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Chemistry

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Also known as: 154229-18-2, Zytiga, Cb7630, Cb-7630, Yonsa, Cb 7630
Molecular Formula
C26H33NO2
Molecular Weight
391.5  g/mol
InChI Key
UVIQSJCZCSLXRZ-UBUQANBQSA-N
FDA UNII
EM5OCB9YJ6

Abiraterone Acetate
An androstene derivative that inhibits STEROID 17-ALPHA-HYDROXYLASE and is used as an ANTINEOPLASTIC AGENT in the treatment of metastatic castration-resistant PROSTATE CANCER.
1 2D Structure

Abiraterone Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl] acetate
2.1.2 InChI
InChI=1S/C26H33NO2/c1-17(28)29-20-10-12-25(2)19(15-20)6-7-21-23-9-8-22(18-5-4-14-27-16-18)26(23,3)13-11-24(21)25/h4-6,8,14,16,20-21,23-24H,7,9-13,15H2,1-3H3/t20-,21-,23-,24-,25-,26+/m0/s1
2.1.3 InChI Key
UVIQSJCZCSLXRZ-UBUQANBQSA-N
2.1.4 Canonical SMILES
CC(=O)OC1CCC2(C3CCC4(C(C3CC=C2C1)CC=C4C5=CN=CC=C5)C)C
2.1.5 Isomeric SMILES
CC(=O)O[C@H]1CC[C@@]2([C@H]3CC[C@]4([C@H]([C@@H]3CC=C2C1)CC=C4C5=CN=CC=C5)C)C
2.2 Other Identifiers
2.2.1 UNII
EM5OCB9YJ6
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 17-(3-pyridyl)-5,16-androstadien-3beta-acetate

2. Cb 7630

3. Cb-7630

4. Cb7630

5. Zytiga

2.3.2 Depositor-Supplied Synonyms

1. 154229-18-2

2. Zytiga

3. Cb7630

4. Cb-7630

5. Yonsa

6. Cb 7630

7. Abiraterone Acetate [usan]

8. 17-(3-pyridyl)-5,16-androstadien-3beta-acetate

9. Em5ocb9yj6

10. [(3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-yl] Acetate

11. Nsc-748121

12. Nsc-749227

13. Chebi:68639

14. (3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-(pyridin-3-yl)-2,3,4,7,8,9,10,11,12,13,14,15-dodecahydro-1h-cyclopenta[a]phenanthren-3-yl Acetate

15. 17-(pyridin-3-yl)androsta-5,16-dien-3beta-yl Acetate

16. (3beta)-17-(pyridin-3-yl)androsta-5,16-dien-3-yl Acetate

17. Abiraterone Acotate

18. 17-(3-pyridyl)androsta-5, Acetate

19. Androsta-5, 17-(3-pyridinyl)-, 3-acetate,

20. Unii-em5ocb9yj6

21. Abiraterone-acetate

22. Ncgc00186462-01

23. 3s,9s,10r,13s,14s)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-ol, 3-acetate

24. Abiraterone Acetate

25. Mfcd00934213

26. Zytiga (tn)

27. Abiraterone (acetate)

28. Jnj-212082

29. Abiraterone Acetate- Bio-x

30. Dsstox_cid_28969

31. Dsstox_rid_83234

32. Dsstox_gsid_49043

33. Schembl93715

34. Mls006010090

35. Chembl271227

36. Gtpl9288

37. Abiraterone Acetate (jan/usp)

38. 3beta-17-(3-pyridyl)androsta-5,16-dien-3-ol Acetate

39. Abiraterone (as Acetate)

40. Abiraterone Acetate [mi]

41. Dtxsid3049043

42. Abiraterone Acetate [jan]

43. Ex-a107

44. Abiraterone Acetate [vandf]

45. Abiraterone Acetate [mart.]

46. Bcp02949

47. Zinc3809191

48. Tox21_113589

49. Abiraterone Acetate [usp-rs]

50. Abiraterone Acetate [who-dd]

51. Bdbm50407398

52. Nsc748121

53. Nsc749227

54. S2246

55. Abiraterone Acetate, >=98% (hplc)

56. Akos015896502

57. Cs-0544

58. Ds-2007

59. Jnj 212082

60. Nsc 748121

61. Nsc 749227

62. Jnj-2012082

63. Abiraterone Acetate [orange Book]

64. Ncgc00379022-06

65. Ac-25760

66. Ba164133

67. Hy-75054

68. Smr004701235

69. Abiraterone Acetate [usp Monograph]

70. Cas-154229-18-2

71. D09701

72. 3b-acetoxy-17-(3-pyridyl)androsta-5,16-diene

73. A809510

74. 3beta-acetoxy-17-(3-pyridyl)androsta-5,16-diene

75. W-201385

76. Brd-k24048528-001-02-5

77. Q27888393

78. (3s)-3-acetoxy-17-(pyridin-3-yl)androsta-5,16-diene

79. (3?)-17-(3-pyridinyl)androsta-5,16-dien-3-yl Acetate

80. (3beta)-17-(3-pyridinyl)androsta-5,16-dien-3-ol Acetate

81. 17-(pyridin-3-yl)androsta-5,16-dien-3.beta.-yl Acetate

82. Abiraterone Acetate, United States Pharmacopeia (usp) Reference Standard

83. Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, Acetate (ester), (3beta)-

84. Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, Acetate (ester), (3.beta.)-

85. (1s,2r,5s,10r,11s,15s)-2,15-dimethyl-14-(pyridin-3-yl)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-7,13-dien-5-yl Acetate

86. [(3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-yl] Ethanoate

87. Acetic Acid [(3s,8r,9s,10r,13s,14s)-10,13-dimethyl-17-(3-pyridinyl)-2,3,4,7,8,9,11,12,14,15-decahydro-1h-cyclopenta[a]phenanthren-3-yl] Ester

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 391.5 g/mol
Molecular Formula C26H33NO2
XLogP35.2
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass391.251129295 g/mol
Monoisotopic Mass391.251129295 g/mol
Topological Polar Surface Area39.2 Ų
Heavy Atom Count29
Formal Charge0
Complexity739
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Zytiga is indicated with prednisone or prednisolone for:

- the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

- the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.


Abiraterone Mylan is indicated with prednisone or prednisolone for:

- the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

- the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

- the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.


Abiraterone Krka is indicated with prednisone or prednisolone for:

- the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5. 1)

- the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)

- the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)


Cytochrome P-450 Enzyme Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 ENZYMES. (See all compounds classified as Cytochrome P-450 Enzyme Inhibitors.)


Steroid Synthesis Inhibitors

Compounds that bind to and inhibit enzymes involved in the synthesis of STEROIDS. (See all compounds classified as Steroid Synthesis Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Cytochrome P450 17A1 Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]; Cytochrome P450 17A1 Inhibitor [EPC]
5.3 ATC Code

L02BX03


L02BX03


L02BX03


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REDDY\\\\\\'S LABORATORIES","customerCountry":"INDIA","quantity":"45.16","actualQuantity":"45.162","unit":"KGS","unitRateFc":"5500","totalValueFC":"253796.9","currency":"USD","unitRateINR":"466675","date":"26-Aug-2024","totalValueINR":"21075976.35","totalValueInUsd":"253796.9","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29372900","bill_no":"5247648","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Micronized","supplierPort":"MEXICO CITY","supplierAddress":"CARRETERA FEDERAL CUERNAVACA JIUTEPEC SDNF Mexico","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"ABIRATERONE ACETATE USP MICRONIZEDANRA00069J","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"INDUSTRIAS QUIMICAS FALCON ","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"DR. REDDY\\\\\\'S LABORATORIES","customerCountry":"INDIA","quantity":"39.31","actualQuantity":"39.312","unit":"KGS","unitRateFc":"5500","totalValueFC":"220921.7","currency":"USD","unitRateINR":"466675","date":"26-Aug-2024","totalValueINR":"18345927.6","totalValueInUsd":"220921.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29372900","bill_no":"5247648","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Micronized","supplierPort":"MEXICO CITY","supplierAddress":"CARRETERA FEDERAL CUERNAVACA JIUTEPEC SDNF Mexico","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"ABIRATERONE ACETATE USP MICRONIZEDANRA00078K","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"INDUSTRIAS QUIMICAS FALCON ","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"DR. REDDY\\\\\\'S LABORATORIES","customerCountry":"INDIA","quantity":"16.25","actualQuantity":"16.252","unit":"KGS","unitRateFc":"5500","totalValueFC":"91331.4","currency":"USD","unitRateINR":"466675","date":"26-Aug-2024","totalValueINR":"7584402.1","totalValueInUsd":"91331.4","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29372900","bill_no":"5247648","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Micronized","supplierPort":"MEXICO CITY","supplierAddress":"CARRETERA FEDERAL CUERNAVACA JIUTEPEC SDNF Mexico","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"(N.C.V.) (ABIRATERONE ACETATE MICROFINE 3 30C PLASTIC JAR INALU BAG ) (FOR R&D UNIT ONLY)","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.52","actualQuantity":"515.45","unit":"GMS","unitRateFc":"14.6","totalValueFC":"8516.6","currency":"EUR","unitRateINR":"1372.1","date":"31-Aug-2024","totalValueINR":"707242.34","totalValueInUsd":"8516.6","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"5342849","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , BelgiumSDNF Belgium","customerAddress":"30 FORJETT STREET"}]
06-Jan-2021
31-Aug-2024
KGS
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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

API Imports and Exports

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(USD/KGS)
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Drugs in Development

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Details:

Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga® (abiraterone acetate), is an anticancer medication. It works by preventing androgen (male hormone) production in man.


Lead Product(s): Abiraterone Acetate,Prednisone

Therapeutic Area: Oncology Product Name: Abiraterone Acetate-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 19, 2020

Dr Reddy Company Banner

01

Lead Product(s) : Abiraterone Acetate,Prednisone

Therapeutic Area : Oncology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga® (abiraterone acetate), is an anticancer medication. It works by preventing androgen (male hormone) production in man...

Product Name : Abiraterone Acetate-Generic

Product Type : Small molecule

Upfront Cash : Not Applicable

June 19, 2020

Dr Reddy Company Banner

Details:

Abiraterone and the combination product Abiraterone/Prednisolone are used to treat men with prostate cancer. The 500 mg (mono product) and 500 mg + 5 mg (combination product) tablets will be marketed in Europe by our partners.


Lead Product(s): Abiraterone Acetate,Prednisolone

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 17, 2022

Tiefenbacher Compnay Banner

02

26th North American ISSX
Not Confirmed

Details : Abiraterone and the combination product Abiraterone/Prednisolone are used to treat men with prostate cancer. The 500 mg (mono product) and 500 mg + 5 mg (combination product) tablets will be marketed in Europe ...

Product Name : Undisclosed

Product Type : Small molecule

Upfront Cash : Not Applicable

November 17, 2022

Tiefenbacher Compnay Banner

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 Product Name: Akeega

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: JANSSEN BIOTECH

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2024

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03

26th North American ISSX
Not Confirmed
26th North American ISSX
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 : Small molecule

Upfront Cash : Not Applicable

July 01, 2024

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Details:

KPG-121 is a modulator of the CRL4CRBN complex targeting rapid ubiquitination and degradation of CK1 alpha, IKZF3 and IKZF1. It is being investigated in combination with Abiraterone for mCRPC.


Lead Product(s): Lenalidomide Analog,Abiraterone Acetate

Therapeutic Area: Oncology Product Name: KPG-121

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2024

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04

26th North American ISSX
Not Confirmed
26th North American ISSX
Not Confirmed

Lead Product(s) : Lenalidomide Analog,Abiraterone Acetate

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : KPG-121 is a modulator of the CRL4CRBN complex targeting rapid ubiquitination and degradation of CK1 alpha, IKZF3 and IKZF1. It is being investigated in combination with Abiraterone for mCRPC.

Product Name : KPG-121

Product Type : Small molecule

Upfront Cash : Not Applicable

June 05, 2024

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Details:

Under the agreement, Novartis obtains worldwide development and commercialization rights of ARV-766, Arvinas’ second generation PROTAC® androgen receptor (AR) degrader for patients with prostate cancer and also its preclinical AR-V7 program.


Lead Product(s): Luxdegalutamide,Abiraterone Acetate

Therapeutic Area: Oncology Product Name: ARV-766

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

Deal Size: $1,160.0 million Upfront Cash: $150.0 million

Deal Type: Licensing Agreement April 11, 2024

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05

Arvinas

U.S.A
arrow
26th North American ISSX
Not Confirmed

Arvinas

U.S.A
arrow
26th North American ISSX
Not Confirmed

Details : Under the agreement, Novartis obtains worldwide development and commercialization rights of ARV-766, Arvinas’ second generation PROTAC® androgen receptor (AR) degrader for patients with prostate cancer and a...

Product Name : ARV-766

Product Type : Small molecule

Upfront Cash : $150.0 million

April 11, 2024

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Details:

JNJ-64091742 (niraparib) is an orally administered, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that is currently being studied for the treatment of metastatic castrationresistant prostate cancer with BRCA alterations.


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

Therapeutic Area: Oncology Product Name: JNJ-64091742

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 22, 2023

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06

26th North American ISSX
Not Confirmed
26th North American ISSX
Not Confirmed

Details : JNJ-64091742 (niraparib) is an orally administered, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that is currently being studied for the treatment of metastatic castrationresistant prostate ca...

Product Name : JNJ-64091742

Product Type : Small molecule

Upfront Cash : Not Applicable

October 22, 2023

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Details:

Lynparza (olaparib) is a first-in-class PARP inhibitor and approved in combination with abiraterone for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.


Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone

Therapeutic Area: Oncology Product Name: Lynparza

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2023

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07

AstraZeneca

United Kingdom
arrow
26th North American ISSX
Not Confirmed

AstraZeneca

United Kingdom
arrow
26th North American ISSX
Not Confirmed

Details : Lynparza (olaparib) is a first-in-class PARP inhibitor and approved in combination with abiraterone for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.

Product Name : Lynparza

Product Type : Small molecule

Upfront Cash : Not Applicable

August 24, 2023

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Details:

USFDA approves FoundationOne®CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate), the first-and-only dual action tablet, which was approved for deleterious BRCA-mutated metastatic castration-resistant prostate cancer in adults.


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

Therapeutic Area: Oncology Product Name: Akeega

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 14, 2023

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08

26th North American ISSX
Not Confirmed
26th North American ISSX
Not Confirmed

Details : USFDA approves FoundationOne®CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate), the first-and-only dual action tablet, which was approved for deleterious BRCA-mutated meta...

Product Name : Akeega

Product Type : Small molecule

Upfront Cash : Not Applicable

August 14, 2023

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Details:

KEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with BRCA-positive mCRPC.


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

Therapeutic Area: Oncology Product Name: Akeega

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2023

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09

26th North American ISSX
Not Confirmed
26th North American ISSX
Not Confirmed

Details : KEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with BRCA-posi...

Product Name : Akeega

Product Type : Small molecule

Upfront Cash : Not Applicable

August 11, 2023

blank

Details:

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.


Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone

Therapeutic Area: Oncology Product Name: Lynparza

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Merck & Co

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 13, 2023

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10

AstraZeneca

United Kingdom
arrow
26th North American ISSX
Not Confirmed

AstraZeneca

United Kingdom
arrow
26th North American ISSX
Not Confirmed

Details : Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment which leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and t...

Product Name : Lynparza

Product Type : Small molecule

Upfront Cash : Not Applicable

July 13, 2023

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FDA Orange Book

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01

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2020-05-18

Application Number : 208416

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

02

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2023-09-01

Application Number : 208416

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

03

QILU

China
26th North American ISSX
Not Confirmed
arrow

QILU

China
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2019-09-27

Application Number : 212462

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

QILU

China
26th North American ISSX
Not Confirmed
arrow

QILU

China
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2021-06-25

Application Number : 212462

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

RISING

U.S.A
26th North American ISSX
Not Confirmed
arrow

RISING

U.S.A
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2019-02-25

Application Number : 208371

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

26th North American ISSX
Not Confirmed
arrow
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2018-10-31

Application Number : 208432

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

26th North American ISSX
Not Confirmed
arrow
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2023-01-26

Application Number : 210726

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

26th North American ISSX
Not Confirmed
arrow
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Approval Date : 2022-06-24

Application Number : 212206

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

MYLAN

U.S.A
26th North American ISSX
Not Confirmed
arrow

MYLAN

U.S.A
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2018-10-31

Application Number : 208446

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

10

MYLAN

U.S.A
26th North American ISSX
Not Confirmed
arrow

MYLAN

U.S.A
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

Brand Name : ABIRATERONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2020-12-14

Application Number : 208446

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 250MG

USFDA APPLICATION NUMBER - 202379

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DOSAGE - TABLET;ORAL - 500MG

USFDA APPLICATION NUMBER - 202379

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US Patents

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01

arrow
26th North American ISSX
Not Confirmed

SUN PHARM

India
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

US Patent Number : 9889144

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210308

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-03-17

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02

arrow
26th North American ISSX
Not Confirmed

SUN PHARM

India
arrow
26th North American ISSX
Not Confirmed

ABIRATERONE ACETATE

US Patent Number : 10292990

Drug Substance Claim :

Drug Product Claim :

Application Number : 210308

Patent Use Code : U-2535

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-05-20

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