Synopsis
Synopsis
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USDMF
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 84500-001
Start Marketing Date : 2022-06-04
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1[iU]/[iU])
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF

NDC Package Code : 71052-042
Start Marketing Date : 2022-11-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1[iU]/[iU])
Marketing Category : BULK INGREDIENT

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NDC Package Code : 71052-042
Start Marketing Date : 2022-11-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1[iU]/[iU])
Marketing Category : BULK INGREDIENT

NDC Package Code : 84500-001
Start Marketing Date : 2022-06-04
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1[iU]/[iU])
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : We are a world class innovation driven specialty pharmaceutical company with integrated Research, Development, Manufacturing and Marketing of Quality affordable medicines for a Hea...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Details:
Isatuximab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Lead Product(s):
Isatuximab,Dexamethasone,Fludarabine Phosphate,Cytarabine,Daunorubicin,Idarubicin Hydrochloride,Filgrastim,Mitoxantrone,Doxorubicin Hydrochloride,
Therapeutic Area: Oncology
Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibody, Unconjugated Sponsor:
Undisclosed
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
March 04, 2019
Lead Product(s) : Dexamethasone, Fludarabine Phosphate, Cytarabine, Daunorubicin, Idarubicin Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Isatuximab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
March 04, 2019
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Details:
Blincyto (Blinatumomab) is an antibody candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Leukemia, Lymphoid.
Lead Product(s):
Blinatumomab,Peg L asparaginase,Cyclophosphamide,Cytarabine,Dexamethasone,Doxorubicin Hydrochloride,Etoposide,Mercaptopurine,
Therapeutic Area: Oncology
Brand Name: Blincyto
Study Phase: Phase IIProduct Type: Antibody, Unconjugated Sponsor:
Undisclosed
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
November 12, 2025

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Lead Product(s) : Blinatumomab, Peg L asparaginase, Cyclophosphamide, Cytarabine, Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Blincyto (Blinatumomab) is an antibody candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Leukemia, Lymphoid.
Product Name : Blincyto
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
November 12, 2025

Details:
Calaspargase Pegol is a Enzyme drug candidate, which is currently being evaluated in Phase II/ Phase III clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Lead Product(s):
Peg L asparaginase,Cyclophosphamide,Cytarabine,Daratumumab,Daunorubicin HCl,Dexamethasone,Doxorubicin Hydrochloride,Mercaptopurine,
Therapeutic Area: Oncology
Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Enzyme Sponsor:
Undisclosed
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
July 18, 2025

Lead Product(s) : Peg L asparaginase, Cyclophosphamide, Cytarabine, Daratumumab, Daunorubicin HCl
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Daratumumab + Chemotherapy Safety & Efficacy In Newly Diagnosed T-ALL & T-LL
Details : Calaspargase Pegol is a Enzyme drug candidate, which is currently being evaluated in Phase II/ Phase III clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Product Name : Undisclosed
Product Type : Enzyme
Upfront Cash : Inapplicable
July 18, 2025

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Details:
Dexamethasone is a Steroid drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Precursor T-Cell Lymphoblastic Leukemia-Lymphoma.
Lead Product(s):
Dexamethasone,Vincristine Sulfate,Daunorubicin,Peg L asparaginase,Dasatinib,Methotrexate,Hydrocortisone,Cytarabine,
Therapeutic Area: Oncology
Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Steroid Sponsor:
AbbVie Inc
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
April 30, 2024

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Lead Product(s) : Dexamethasone, Vincristine Sulfate, Daunorubicin, Peg L asparaginase, Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : AbbVie Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dexamethasone is a Steroid drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Precursor T-Cell Lymphoblastic Leukemia-Lymphoma.
Product Name : Undisclosed
Product Type : Steroid
Upfront Cash : Inapplicable
April 30, 2024

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Details:
Dexamethasone is a Steroid drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Lead Product(s):
Dexamethasone,Mitoxantrone,Peg L asparaginase,Bortezomib,Vorinostat,Mercaptopurine,Methotrexate,Blinatumomab,
Therapeutic Area: Oncology
Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Steroid Sponsor:
Tanja Andrea Gruber
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
May 08, 2023

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Lead Product(s) : Dexamethasone, Mitoxantrone, Peg L asparaginase, Bortezomib, Vorinostat
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Tanja Andrea Gruber
Deal Size : Inapplicable
Deal Type : Inapplicable
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Details : Dexamethasone is a Steroid drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Product Name : Undisclosed
Product Type : Steroid
Upfront Cash : Inapplicable
May 08, 2023

Details:
Bone Marrow Aspiration is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Acute Leukemias of Ambiguous Lineage.
Lead Product(s): Bone Marrow Aspiration,Peg L asparaginase,Cytarabine,Fludarabine Phosphate,Hydrocortisone Sodium Succinate,Lumbar Puncture,Methotrexate,Prednisolone,Prednisone,Revumenib
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 09, 2023

Lead Product(s) : Peg L asparaginase, Cytarabine, Fludarabine Phosphate, Hydrocortisone Sodium Succinate, Methotrexate
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bone Marrow Aspiration is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Acute Leukemias of Ambiguous Lineage.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
March 09, 2023

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Details:
Sugemalimab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lymphoma, Extranodal NK-T-Cell.
Lead Product(s): Sugemalimab,Peg L asparaginase,Gemcitabine,Oxaliplatin
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 26, 2023

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Lead Product(s) : Sugemalimab,Peg L asparaginase,Gemcitabine,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sugemalimab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lymphoma, Extranodal NK-T-Cell.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
January 26, 2023

Details:
Calaspargase Pegol is a Enzyme drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Precursor B-Cell Lymphoblastic Leukemia-Lymphoma.
Lead Product(s): Peg L asparaginase,Levocarnitine
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Enzyme
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 02, 2022

Lead Product(s) : Peg L asparaginase,Levocarnitine
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Calaspargase Pegol is a Enzyme drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Precursor B-Cell Lymphoblastic Leukemia-Lymphoma.
Product Name : Undisclosed
Product Type : Enzyme
Upfront Cash : Inapplicable
November 02, 2022

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Details:
Hyper Cvad Protocol is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Lead Product(s): Hyper Cvad Protocol,Peg L asparaginase,Rituximab
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Cytotoxic Drug
Sponsor: Servier
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 14, 2022

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Lead Product(s) : Hyper Cvad Protocol,Peg L asparaginase,Rituximab
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Servier
Deal Size : Inapplicable
Deal Type : Inapplicable
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Details : Hyper Cvad Protocol is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
October 14, 2022

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Details:
JNJ-75276617 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia.
Lead Product(s): Bleximenib,Fludarabine Phosphate,Cytarabine,Dexamethasone,Vincristine Sulfate,Peg L asparaginase
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 30, 2022

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Lead Product(s) : Bleximenib, Fludarabine Phosphate, Cytarabine, Dexamethasone, Vincristine Sulfate
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : JNJ-75276617 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 30, 2022

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RLD :
TE Code :
ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN
Brand Name : RYLAZE
Dosage Form : INJECTABLE;INTRAMUSCULAR
Dosage Strength : 10MG/0.5ML
Approval Date :
Application Number : 761179
RX/OTC/DISCN :
RLD :
TE Code :

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RLD :
TE Code :
Brand Name : ELSPAR
Dosage Form : VIAL
Dosage Strength : 10,000IU/VIAL
Approval Date :
Application Number : 101063
RX/OTC/DISCN :
RLD :
TE Code :

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RLD :
TE Code :
Brand Name : ASPARLAS
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 3750UNITS/5ML
Approval Date :
Application Number : 761102
RX/OTC/DISCN :
RLD :
TE Code :

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RLD :
TE Code :
Brand Name : ONCASPAR
Dosage Form : VIAL
Dosage Strength : 750IU/VIAL
Approval Date :
Application Number : 103411
RX/OTC/DISCN :
RLD :
TE Code :

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Oncaspar UIml
Dosage Form : Powder For Injectable Solution
Dosage Strength : 750IU
Packaging :
Approval Date : 10/12/2018
Application Number : 66934
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Oncaspar
Dosage Form : Injection/Infusion Solution
Dosage Strength : 750IU/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Oncaspar
Dosage Form : Injection/Infusion Solution
Dosage Strength : 3750units
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Oncaspar
Dosage Form : Injectable And Perfusion Solution
Dosage Strength : 750UNIT
Packaging :
Approval Date : 09-05-2016
Application Number : 1151070001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Oncaspar
Dosage Form : Powder For Injection And Infusion Solution
Dosage Strength : 750UNIT
Packaging :
Approval Date : 02-02-2018
Application Number : 1151070002
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Oncaspar
Dosage Form : Injection/Infusion Solution
Dosage Strength : 750 U/ml
Packaging :
Approval Date : 14-01-2016
Application Number : 28105480214
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Oncaspar
Dosage Form : Injection/Infusion Solution
Dosage Strength : 750 U/ml
Packaging :
Approval Date : 08-12-2017
Application Number : 28105923017
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Oncaspar
Dosage Form : Solution For Injection/Infusion
Dosage Strength : 750U/ml
Packaging :
Approval Date : 14-01-2016
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oncaspar
Dosage Form : Injection/Infusion Solution
Dosage Strength : 750U/ml
Packaging :
Approval Date : 11-12-2017
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]https://www.pharmacompass.com/radio-compass-blog/us-drug-shortages-reduce-16-yoy-in-q1-2025-cns-drugs-antimicrobials-face-highest-scarcities

26 Nov 2024
// BUSINESS STD
https://www.business-standard.com/markets/capital-market-news/kwality-pharma-gains-on-receiving-nod-for-pegylated-asparaginase-124112600383_1.html

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761102

22 Dec 2022
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103411

12 Dec 2022
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/real-world-analysis-suggests-pediatric-inspired-regimens-lead-to-higher-overall-survival-in-adolescent-and-young-adult-patients-with-newly-diagnosed-acute-lymphoblastic-leukemia-301700806.html

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761102

11 Dec 2021
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-presents-positive-interim-phase-23-results-of-rylaze-asparaginase-erwinia-chrysanthemi-recombinant-rywn-in-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-at-ash-2021-annual-meeting-301442693.html
Global Sales Information
Main Therapeutic Indication : Oncology
Currency : USD
2018 Revenue in Millions : 5
2017 Revenue in Millions : 0
Growth (%) : New Launch

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