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Also known as: 1038915-73-9, Mk-4827 tosylate, Mk-4827 (tosylate), Mk-4827-tosylate, Niraparib (tosylate), Mk 4827 tosylate
Molecular Formula
C26H28N4O4S
Molecular Weight
492.6  g/mol
InChI Key
LCPFHXWLJMNKNC-PFEQFJNWSA-N
FDA UNII
75KE12AY9U

Niraparib Tosylate
1 2D Structure

Niraparib Tosylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-methylbenzenesulfonic acid;2-[4-[(3S)-piperidin-3-yl]phenyl]indazole-7-carboxamide
2.1.2 InChI
InChI=1S/C19H20N4O.C7H8O3S/c20-19(24)17-5-1-3-15-12-23(22-18(15)17)16-8-6-13(7-9-16)14-4-2-10-21-11-14;1-6-2-4-7(5-3-6)11(8,9)10/h1,3,5-9,12,14,21H,2,4,10-11H2,(H2,20,24);2-5H,1H3,(H,8,9,10)/t14-;/m1./s1
2.1.3 InChI Key
LCPFHXWLJMNKNC-PFEQFJNWSA-N
2.1.4 Canonical SMILES
CC1=CC=C(C=C1)S(=O)(=O)O.C1CC(CNC1)C2=CC=C(C=C2)N3C=C4C=CC=C(C4=N3)C(=O)N
2.1.5 Isomeric SMILES
CC1=CC=C(C=C1)S(=O)(=O)O.C1C[C@H](CNC1)C2=CC=C(C=C2)N3C=C4C=CC=C(C4=N3)C(=O)N
2.2 Other Identifiers
2.2.1 UNII
75KE12AY9U
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 1038915-73-9

2. Mk-4827 Tosylate

3. Mk-4827 (tosylate)

4. Mk-4827-tosylate

5. Niraparib (tosylate)

6. Mk 4827 Tosylate

7. Niraparib (mk-4827) Tosylate

8. (s)-2-(4-(piperidin-3-yl)phenyl)-2h-indazole-7-carboxamide 4-methylbenzenesulfonate

9. 75ke12ay9u

10. Mk-4827(niraparib) Tosylate

11. 2h-indazole-7-carboxamide, 2-(4-(3s)-3-piperidinylphenyl)-, 4-methylbenzenesulfonate (1:1)

12. Unii-75ke12ay9u

13. Niraparib Tosylate Monohyrate

14. Niraparib(mk-4827) Tosylate

15. Schembl20522624

16. Dtxsid801026487

17. Hy-10619b

18. Mfcd28167748

19. S7625

20. Ccg-269634

21. Niraparib Tosylate [orange Book]

22. Ac-30383

23. As-56981

24. A11848

25. A909268

26. Q27266392

27. (3s)-3-[4-[7-(aminocarbonyl)-2h-indazol-2-yl]phenyl]piperidine Tosylate

28. (s)-2-(4-(piperidin-3-yl)phenyl)-2h-indazole-7-carboxamide 4-?methylbenzenesulfona?te

29. 4-methylbenzenesulfonic Acid;2-[4-[(3s)-piperidin-3-yl]phenyl]indazole-7-carboxamide

30. 2-{4-[(3s)-piperidin-3-yl]phenyl}-2h-indazole-7-carboxamide; 4-methylbenzene-1-sulfonic Acid

2.4 Create Date
2014-10-10
3 Chemical and Physical Properties
Molecular Weight 492.6 g/mol
Molecular Formula C26H28N4O4S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass492.18312656 g/mol
Monoisotopic Mass492.18312656 g/mol
Topological Polar Surface Area136 Ų
Heavy Atom Count35
Formal Charge0
Complexity655
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameZEJULA
Active IngredientNIRAPARIB TOSYLATE
CompanyTESARO INC (Application Number: N208447. Patents: 8071623, 8436185)

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Dr. Reddy's Laboratories

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Lee Fine Chem

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Sichuan Qingmu Pharmaceutical

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LABORATORIES","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"16500","totalValueFC":"13335.6","currency":"USD","unitRateINR":"1393425","date":"10-Jul-2024","totalValueINR":"1114740","totalValueInUsd":"13335.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4430180","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.518, LAO DONG EAST ROAD, CHANGZHOU JIANGSU 213018, CHINA. Changzhou, , China China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721154600,"product":"NIRAPARIB TOSYLATE MONOHYDRATE","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"NANTONG CHANYOO PHARMATECH COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"NATCO PHARMA LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"13000","totalValueFC":"13133.6","currency":"USD","unitRateINR":"1097850","date":"17-Jul-2024","totalValueINR":"1097850","totalValueInUsd":"13133.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4556418","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO,2 TONGHAI SI ROAD,YANGKOU CHEMICAL INDUSTRIAL PARK,RUDONG COASTAL,ECOOMIC DEVELOPMENT ZONE,NANTONG CN","customerAddress":"NATCO HOUSE, ROAD NO.2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"NIRAPARIB TOSYLATE MONOHYDRATE","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"12000","totalValueFC":"24163.8","currency":"USD","unitRateINR":"1015200","date":"01-Oct-2024","totalValueINR":"2030400","totalValueInUsd":"24163.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5903809","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.518, LAO DONG EAST ROAD, CHANGZH OU JIANGSU 213018, CHINA. Changzhou , , China China","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730226600,"product":"NIRAPARIB TOSYLATE MONOHYDRATE","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"NANTONG CHANYOO PHARMATECH COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PU DONG APT","customer":"NATCO PHARMA LTD","customerCountry":"INDIA","quantity":"122.00","actualQuantity":"122","unit":"KGS","unitRateFc":"8950","totalValueFC":"1103899.9","currency":"USD","unitRateINR":"760302.5","date":"30-Oct-2024","totalValueINR":"92756905","totalValueInUsd":"1103899.9","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29339990","bill_no":"6423469","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PU DONG APT","supplierAddress":"NO,2 TONGHAI SI ROAD,YANGKOU CHEMIC AL INDUSTRIAL PARK,RUDONG COASTAL, SDNF China","customerAddress":"NATCO HOUSE, ROAD NO.2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"NIRAPARIB TOSYLATE MONOHYDRATE NIRAPARIB TOSYLATE MONOHYDRATE FOR R & D PURPOSE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CHANGZHOU PHARMACEUTICAL FACTORY","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"12000","totalValueFC":"36415.6","currency":"USD","unitRateINR":"1031400","date":"21-Dec-2024","totalValueINR":"3094200","totalValueInUsd":"36415.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7380284","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.518, LAO DONG EAST ROAD, CHANGZH OU JIANGSU 213018, CHINA. Changzhou , China China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"NIRAPARIB TOSYLATE MONOHYDRATE","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"NANTONG CHANYOO PHARMATECH COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PU DONG APT","customer":"NATCO PHARMA LTD","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"8050","totalValueFC":"122158.1","currency":"USD","unitRateINR":"697130","date":"15-Apr-2025","totalValueINR":"10456950","totalValueInUsd":"122158.1","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29339990","bill_no":"9491288","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PU DONG APT","supplierAddress":"NO,2 TONGHAI SI ROAD,YANGKOU CHEMIC AL INDUSTRIAL PARK,RUDONG COASTAL, SDNF China","customerAddress":"NATCO HOUSE, ROAD NO.2,"}]
13-Jun-2023
05-May-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
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Drugs in Development

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Details:

Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Ovarian Neoplasms.


Lead Product(s): Niraparib Tosylate,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 09, 2025

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01

Tesaro

U.S.A
arrow
FNCE
Not Confirmed

Tesaro

U.S.A
arrow
FNCE
Not Confirmed

Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Ovarian Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 09, 2025

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Details:

IMNN-001 is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Ovarian Epithelial.


Lead Product(s): IMNN-001,Paclitaxel,Carboplatin,Olaparib,Niraparib Tosylate

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Cell & Gene Therapy

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 07, 2025

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02

Imunon

U.S.A
arrow
FNCE
Not Confirmed

Imunon

U.S.A
arrow
FNCE
Not Confirmed

Details : IMNN-001 is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Ovarian Epithelial.

Product Name : Undisclosed

Product Type : Cell & Gene Therapy

Upfront Cash : Inapplicable

April 07, 2025

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  • Development Update

Details:

Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ovarian Neoplasms.


Lead Product(s): Niraparib Tosylate,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 21, 2025

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03

GSK

United Kingdom
arrow
FNCE
Not Confirmed

GSK

United Kingdom
arrow
FNCE
Not Confirmed

Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ovarian Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 21, 2025

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Details:

ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.


Lead Product(s): Azenosertib,Niraparib Tosylate

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 09, 2025

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04

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 09, 2025

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  • Development Update

Details:

Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.


Lead Product(s): Niraparib Tosylate,Ipilimumab

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Lustgarten Foundation | GSK | Bristol Myers Squibb

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 24, 2024

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05

Abramson Cancer Center at Penn Medicine

Country
arrow
FNCE
Not Confirmed

Abramson Cancer Center at Penn Medicine

Country
arrow
FNCE
Not Confirmed

Lead Product(s) : Niraparib Tosylate,Ipilimumab

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Lustgarten Foundation | GSK | Bristol Myers Squibb

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 24, 2024

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  • Development Update

Details:

Jemperli (dostarlimab, targets PD-1) in combination with Zejula (niraparib, targets PARP) is being evaluated as a first line treatment in phase 3 ciical trials of ovarian cancer.


Lead Product(s): Dostarlimab,Niraparib Tosylate

Therapeutic Area: Oncology Brand Name: Jemperli

Study Phase: Phase IIIProduct Type: Antibody, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 20, 2024

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06

GSK

United Kingdom
arrow
FNCE
Not Confirmed

GSK

United Kingdom
arrow
FNCE
Not Confirmed

Details : Jemperli (dostarlimab, targets PD-1) in combination with Zejula (niraparib, targets PARP) is being evaluated as a first line treatment in phase 3 ciical trials of ovarian cancer.

Product Name : Jemperli

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

December 20, 2024

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Details:

ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.


Lead Product(s): Azenosertib,Niraparib Tosylate

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 16, 2024

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07

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 16, 2024

blank
  • Development Update

Details:

Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Prostatic Neoplasms.


Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Johnson & Johnson Innovative Medicine

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 30, 2024

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08

Latin American Cooperative Oncology Group

Country
arrow
FNCE
Not Confirmed

Latin American Cooperative Oncology Group

Country
arrow
FNCE
Not Confirmed

Details : Niraparib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Prostatic Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 30, 2024

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Details:

Akeega (niraparib, abiraterone acetate) is a tablet works by inhibiting approved for BRCA-mutated mCRPC in adults. The FDA has approved FoundationOne Liquid CDx as its companion diagnostic.


Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone

Therapeutic Area: Oncology Brand Name: Akeega

Study Phase: Approved FDFProduct Type: Cytotoxic Drug

Sponsor: JANSSEN BIOTECH

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 01, 2024

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09

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : Akeega (niraparib, abiraterone acetate) is a tablet works by inhibiting approved for BRCA-mutated mCRPC in adults. The FDA has approved FoundationOne Liquid CDx as its companion diagnostic.

Product Name : Akeega

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

July 01, 2024

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Details:

ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.


Lead Product(s): Azenosertib,Niraparib Tosylate

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 18, 2024

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10

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : ZN-c3 (azenosertib), is a potentially first-in-class and best-in-class WEE1 inhibitor being investigated for advanced solid tumors and hematologic malignancies.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 18, 2024

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 138229-59-1

End Use API : Niraparib Tosylate

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

CAS Number : 1171197-20-8

End Use API : Niraparib Tosylate

About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

Aarti Industries Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothQingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.

CAS Number : 1335523-82-4

End Use API : Niraparib Tosylate

About The Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing ...

Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothQingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.

CAS Number : 2141967-71-5

End Use API : Niraparib Tosylate

About The Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing ...

Company Banner
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FDA Orange Book

read-more
read-more

01

GLAXOSMITHKLINE

United Kingdom
FNCE
Not Confirmed
arrow

GLAXOSMITHKLINE

United Kingdom
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2017-03-27

Application Number : 208447

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

GLAXOSMITHKLINE

United Kingdom
FNCE
Not Confirmed
arrow

GLAXOSMITHKLINE

United Kingdom
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2023-04-26

Application Number : 214876

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

GLAXOSMITHKLINE

United Kingdom
FNCE
Not Confirmed
arrow

GLAXOSMITHKLINE

United Kingdom
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2023-04-26

Application Number : 214876

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

GLAXOSMITHKLINE

United Kingdom
FNCE
Not Confirmed
arrow

GLAXOSMITHKLINE

United Kingdom
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2023-04-26

Application Number : 214876

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

read-more
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01

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Packaging : Blisterpakning 56item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Packaging : Blisterpakning 84item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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03

Glaxosmithkline Ag

United Kingdom
FNCE
Not Confirmed
arrow

Glaxosmithkline Ag

United Kingdom
arrow
FNCE
Not Confirmed

Niraparibum

Brand Name : Zejula capsules

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 03/10/2018

Application Number : 66763

Regulatory Info : Allowed

Registration Country : Switzerland

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04

Glaxosmithkline Ag

United Kingdom
FNCE
Not Confirmed
arrow

Glaxosmithkline Ag

United Kingdom
arrow
FNCE
Not Confirmed

Niraparibum

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 20/01/2023

Application Number : 68652

Regulatory Info : Allowed

Registration Country : Switzerland

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05

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparib Tosylate Monohydrate

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 2024-04-12

Application Number : 1171235006

Regulatory Info : Authorized

Registration Country : Spain

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06

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparib Tosylate Monohydrate

Brand Name : Zejula

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date : 2018-03-08

Application Number : 1171235001

Regulatory Info : Authorized

Registration Country : Spain

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07

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparib; Abiraterone Acetate

Brand Name : Akeega mg

Dosage Form : Film Coated Tablet

Dosage Strength : 50mg;500mg

Packaging :

Approval Date : 18/04/2024

Application Number : 68977

Regulatory Info : Allowed

Registration Country : Switzerland

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08

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparib; Abiraterone Acetate

Brand Name : Akeega mg

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg;500mg

Packaging :

Approval Date : 18/04/2024

Application Number : 68977

Regulatory Info : Allowed

Registration Country : Switzerland

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09

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Abiraterone Acetate; Niraparib Tosylate Monohydrate

Brand Name : Akeega

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG; 500 MG

Packaging :

Approval Date : 2023-04-27

Application Number : 1231722002

Regulatory Info : Authorized

Registration Country : Spain

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10

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Abiraterone Acetate; Niraparib Tosylate Monohydrate

Brand Name : Akeega

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG; 500 MG

Packaging :

Approval Date : 2023-04-27

Application Number : 1231722001

Regulatory Info : Authorized

Registration Country : Spain

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Australia

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read-more

01

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

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Niraparib

Brand Name : AKEEGA 50 mg /500 mg

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Niraparib

Brand Name : AKEEGA 100 mg /500 mg

Dosage Form : FCT

Dosage Strength : 100mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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01

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Company : Janssen Biotech

Niraparib/Abiraterone

Drug Cost (USD) : 566,563

Year : 2023

Prescribers : 16

Prescriptions : 31

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02

Brand Name : Zejula

United Kingdom
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Brand Name : Zejula

United Kingdom
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Company : Glaxosmithkline

Niraparib Tosylate

Drug Cost (USD) : 161,500,239

Year : 2023

Prescribers : 1886

Prescriptions : 10023

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03

Brand Name : Zejula

United Kingdom
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Brand Name : Zejula

United Kingdom
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Company : Glaxosmithkline

Niraparib Tosylate

Drug Cost (USD) : 154,728,383

Year : 2022

Prescribers : 2211

Prescriptions : 11360

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04

Brand Name : Zejula

United Kingdom
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Brand Name : Zejula

United Kingdom
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Company : Glaxosmithkline

Niraparib Tosylate

Drug Cost (USD) : 152,013,598

Year : 2021

Prescribers : 2662

Prescriptions : 11565

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Company : Tesaro, Inc.

Niraparib Tosylate

Drug Cost (USD) : 364,669

Year : 2021

Prescribers : 15

Prescriptions : 41

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Company : Tesaro, Inc.

Niraparib Tosylate

Drug Cost (USD) : 140,466,403

Year : 2020

Prescribers : 2766

Prescriptions : 10681

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Not Confirmed
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Company : Tesaro, Inc.

Niraparib Tosylate

Drug Cost (USD) : 95,099,948

Year : 2019

Prescribers : 1773

Prescriptions : 7528

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Company : Tesaro, Inc.

Niraparib Tosylate

Drug Cost (USD) : 68,458,312

Year : 2018

Prescribers : 1451

Prescriptions : 5736

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Regulatory FDF Prices

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Brand Name : Zejula

United Kingdom
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Brand Name : Zejula

United Kingdom
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Niraparib Tosylate

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Price Per Pack (Euro) : 3,186.91

Published in :

Country : Norway

RX/OTC/DISCN :

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Brand Name : Zejula

United Kingdom
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Brand Name : Zejula

United Kingdom
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FNCE
Not Confirmed

Niraparib Tosylate

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Price Per Pack (Euro) : 4,780.36

Published in :

Country : Norway

RX/OTC/DISCN :

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Annual Reports

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01

Brand Name : Zejula

Niraparib

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Brand Name : Zejula

United Kingdom
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Not Confirmed

Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2020 Revenue in Millions : 470

2019 Revenue in Millions : 317

Growth (%) : 48

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Brand Name : Zejula

Niraparib

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Not Confirmed

Brand Name : Zejula

United Kingdom
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Not Confirmed

Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2021 Revenue in Millions : 535

2020 Revenue in Millions : 464

Growth (%) : 17

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Brand Name : Zejula

Niraparib

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Not Confirmed

Brand Name : Zejula

United Kingdom
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Not Confirmed

Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2022 Revenue in Millions : 571

2021 Revenue in Millions : 535

Growth (%) : 7

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Brand Name : Zejula

Niraparib

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Not Confirmed

Brand Name : Zejula

United Kingdom
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Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2023 Revenue in Millions : 564

2022 Revenue in Millions : 571

Growth (%) : 13

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Brand Name : Zejula

Niraparib

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Brand Name : Zejula

Japan
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Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2022 Revenue in Millions : 93

2021 Revenue in Millions : 68

Growth (%) : 37

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Brand Name : Zejula

Niraparib

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Brand Name : Zejula

Japan
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Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2023 Revenue in Millions : 97

2022 Revenue in Millions : 93

Growth (%) : 18

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Brand Name : Zejula

Niraparib

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Brand Name : Zejula

United Kingdom
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Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2024 Revenue in Millions : 738

2023 Revenue in Millions : 564

Growth (%) : 31

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Brand Name : Zejula

Niraparib

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Brand Name : Zejula

Japan
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Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2024 Revenue in Millions : 96

2023 Revenue in Millions : 96

Growth (%) : 0

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Brand Name : Zejula

Niraparib

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Brand Name : Zejula

United Kingdom
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Niraparib

Main Therapeutic Indication : Oncology

Currency : USD

2019 Revenue in Millions : 284

2018 Revenue in Millions : 0

Growth (%) : N/A

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Patents & EXCLUSIVITIES

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US Patents

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01

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GLAXOSMITHKLINE

United Kingdom
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NIRAPARIB TOSYLATE

US Patent Number : 8071623

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214876

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-03-27

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GLAXOSMITHKLINE

United Kingdom
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NIRAPARIB TOSYLATE

US Patent Number : 11673877

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 208447

Patent Use Code : U-3646

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-03-27

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GLAXOSMITHKLINE

United Kingdom
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NIRAPARIB TOSYLATE

US Patent Number : 8071579

Drug Substance Claim :

Drug Product Claim :

Application Number : 214876

Patent Use Code : U-2655

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-08-12

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GLAXOSMITHKLINE

United Kingdom
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Not Confirmed

NIRAPARIB TOSYLATE

US Patent Number : 8143241

Drug Substance Claim :

Drug Product Claim :

Application Number : 208447

Patent Use Code : U-2655

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-08-12

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GLAXOSMITHKLINE

United Kingdom
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Not Confirmed

NIRAPARIB TOSYLATE

US Patent Number : 11091459

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 214876

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-03-27

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GLAXOSMITHKLINE

United Kingdom
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Not Confirmed

NIRAPARIB TOSYLATE

US Patent Number : 8071579

Drug Substance Claim :

Drug Product Claim :

Application Number : 208447

Patent Use Code : U-2655

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-08-12

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GLAXOSMITHKLINE

United Kingdom
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Not Confirmed

NIRAPARIB TOSYLATE

US Patent Number : 11091459

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 214876

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-03-27

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Not Confirmed

GLAXOSMITHKLINE

United Kingdom
arrow
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Not Confirmed

NIRAPARIB TOSYLATE

US Patent Number : 8071623

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214876

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-03-27

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Not Confirmed

GLAXOSMITHKLINE

United Kingdom
arrow
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Not Confirmed

NIRAPARIB TOSYLATE

US Patent Number : 11673877

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 214876

Patent Use Code : U-3646

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-03-27

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Not Confirmed

GLAXOSMITHKLINE

United Kingdom
arrow
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Not Confirmed

NIRAPARIB TOSYLATE

US Patent Number : 8071579

Drug Substance Claim :

Drug Product Claim :

Application Number : 214876

Patent Use Code : U-2655

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-08-12

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US Exclusivities

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GLAXOSMITHKLINE

United Kingdom
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NIRAPARIB TOSYLATE

Exclusivity Code : ODE-277

Exclusivity Expiration Date : 2026-10-23

Application Number : 208447

Product Number : 1

Exclusivity Details :

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GLAXOSMITHKLINE

United Kingdom
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NIRAPARIB TOSYLATE

Exclusivity Code : ODE-295

Exclusivity Expiration Date : 2027-04-29

Application Number : 208447

Product Number : 1

Exclusivity Details :

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Health Canada Patents

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01

GlaxoSmithKline Inc.

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GlaxoSmithKline Inc.

Country
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FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 2647545

Filing Date : 2007-04-02

Strength per Unit : 100 mg

Dosage Form : CAPSULE

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2027-04-02

Date Granted : 2016-02-23

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GlaxoSmithKline Inc.

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GlaxoSmithKline Inc.

Country
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 2674436

Filing Date : 2008-01-08

Strength per Unit : 100 mg

Dosage Form : CAPSULE

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2028-01-08

Date Granted : 2012-07-17

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GlaxoSmithKline Inc.

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Not Confirmed

GlaxoSmithKline Inc.

Country
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FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 2711491

Filing Date : 2009-01-08

Strength per Unit : 100 mg

Dosage Form : CAPSULE

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2029-01-08

Date Granted : 2016-03-08

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GlaxoSmithKline Inc.

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Not Confirmed

GlaxoSmithKline Inc.

Country
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FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 3029671

Filing Date : 2017-06-29

Strength per Unit : 100 mg

Dosage Form : CAPSULE

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2037-06-29

Date Granted : 2023-08-15

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GlaxoSmithKline Inc.

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Not Confirmed

GlaxoSmithKline Inc.

Country
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 2647545

Filing Date : 2007-04-02

Strength per Unit : 100mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2027-04-02

Date Granted : 2016-02-23

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GlaxoSmithKline Inc.

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Not Confirmed

GlaxoSmithKline Inc.

Country
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 2674436

Filing Date : 2008-01-08

Strength per Unit : 100mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2028-01-08

Date Granted : 2012-07-17

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GlaxoSmithKline Inc.

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Not Confirmed

GlaxoSmithKline Inc.

Country
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 2711491

Filing Date : 2009-01-08

Strength per Unit : 100mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2029-01-08

Date Granted : 2016-03-08

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GlaxoSmithKline Inc.

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Not Confirmed

GlaxoSmithKline Inc.

Country
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Patent Number : 3029671

Filing Date : 2017-06-29

Strength per Unit : 100mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2037-06-29

Date Granted : 2023-08-15

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Belmore Neidrauer LLP

Country
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE, ABIRATERONE ACETATE

Brand Name : AKEEGA

Patent Number : 2647545

Filing Date : 2007-04-02

Strength per Unit : 50mg / 500mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2027-04-02

Date Granted : 2016-02-23

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Not Confirmed

Belmore Neidrauer LLP

Country
arrow
FNCE
Not Confirmed

NIRAPARIB TOSYLATE, ABIRATERONE ACETATE

Brand Name : AKEEGA

Patent Number : 2674436

Filing Date : 2008-01-08

Strength per Unit : 50mg / 500mg

Dosage Form : TABLET

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2028-01-08

Date Granted : 2012-07-17

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ABOUT THIS PAGE

Looking for 1038915-73-9 / Niraparib Tosylate API manufacturers, exporters & distributors?

Niraparib Tosylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Niraparib Tosylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Niraparib Tosylate manufacturer or Niraparib Tosylate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Niraparib Tosylate manufacturer or Niraparib Tosylate supplier.

PharmaCompass also assists you with knowing the Niraparib Tosylate API Price utilized in the formulation of products. Niraparib Tosylate API Price is not always fixed or binding as the Niraparib Tosylate Price is obtained through a variety of data sources. The Niraparib Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Niraparib Tosylate

Synonyms

1038915-73-9, Mk-4827 tosylate, Mk-4827 (tosylate), Mk-4827-tosylate, Niraparib (tosylate), Mk 4827 tosylate

Cas Number

1038915-73-9

Unique Ingredient Identifier (UNII)

75KE12AY9U

Niraparib Tosylate Manufacturers

A Niraparib Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niraparib Tosylate, including repackagers and relabelers. The FDA regulates Niraparib Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niraparib Tosylate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Niraparib Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Niraparib Tosylate Suppliers

A Niraparib Tosylate supplier is an individual or a company that provides Niraparib Tosylate active pharmaceutical ingredient (API) or Niraparib Tosylate finished formulations upon request. The Niraparib Tosylate suppliers may include Niraparib Tosylate API manufacturers, exporters, distributors and traders.

click here to find a list of Niraparib Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Niraparib Tosylate USDMF

A Niraparib Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Niraparib Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Niraparib Tosylate DMFs exist exist since differing nations have different regulations, such as Niraparib Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Niraparib Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Niraparib Tosylate USDMF includes data on Niraparib Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niraparib Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Niraparib Tosylate suppliers with USDMF on PharmaCompass.

Niraparib Tosylate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Niraparib Tosylate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Niraparib Tosylate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Niraparib Tosylate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Niraparib Tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Niraparib Tosylate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Niraparib Tosylate suppliers with NDC on PharmaCompass.

Niraparib Tosylate GMP

Niraparib Tosylate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Niraparib Tosylate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Niraparib Tosylate GMP manufacturer or Niraparib Tosylate GMP API supplier for your needs.

Niraparib Tosylate CoA

A Niraparib Tosylate CoA (Certificate of Analysis) is a formal document that attests to Niraparib Tosylate's compliance with Niraparib Tosylate specifications and serves as a tool for batch-level quality control.

Niraparib Tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Niraparib Tosylate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Niraparib Tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Niraparib Tosylate EP), Niraparib Tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Niraparib Tosylate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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