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Last Updated: November 22, 2024

MERCAPTOPURINE - Generic Drug Details


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What are the generic drug sources for mercaptopurine and what is the scope of freedom to operate?

Mercaptopurine is the generic ingredient in three branded drugs marketed by Nova Labs Ltd, Dr Reddys Labs Sa, Hikma, Mylan, and Stason Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for mercaptopurine. Three suppliers are listed for this compound.

Summary for MERCAPTOPURINE
Drug Prices for MERCAPTOPURINE

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Recent Clinical Trials for MERCAPTOPURINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lucile Packard Children's Hospital FoundationPhase 1/Phase 2
Stanford UniversityPhase 1/Phase 2
AmgenPhase 1/Phase 2

See all MERCAPTOPURINE clinical trials

Pharmacology for MERCAPTOPURINE
Anatomical Therapeutic Chemical (ATC) Classes for MERCAPTOPURINE

US Patents and Regulatory Information for MERCAPTOPURINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan MERCAPTOPURINE mercaptopurine TABLET;ORAL 040594-001 Jul 1, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa MERCAPTOPURINE mercaptopurine TABLET;ORAL 040461-001 Feb 11, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma MERCAPTOPURINE mercaptopurine TABLET;ORAL 040528-001 Feb 13, 2004 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nova Labs Ltd PURIXAN mercaptopurine SUSPENSION;ORAL 205919-001 Apr 28, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Stason Pharms PURINETHOL mercaptopurine TABLET;ORAL 009053-002 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for MERCAPTOPURINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Nova Laboratories Ireland Limited Xaluprine (previously Mercaptopurine Nova Laboratories) mercaptopurine EMEA/H/C/002022
Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Authorised no no no 2012-03-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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