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Last Updated: March 29, 2024

MERCAPTOPURINE Drug Patent Profile


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When do Mercaptopurine patents expire, and what generic alternatives are available?

Mercaptopurine is a drug marketed by Dr Reddys Labs Sa, Hikma, and Mylan. and is included in three NDAs.

The generic ingredient in MERCAPTOPURINE is mercaptopurine. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mercaptopurine

A generic version of MERCAPTOPURINE was approved as mercaptopurine by DR REDDYS LABS SA on February 11th, 2004.

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Drug patent expirations by year for MERCAPTOPURINE
Drug Prices for MERCAPTOPURINE

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Recent Clinical Trials for MERCAPTOPURINE

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

SponsorPhase
Stanford UniversityPhase 1/Phase 2
AmgenPhase 1/Phase 2
Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumPhase 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
Dr Reddys Labs Sa MERCAPTOPURINE mercaptopurine TABLET;ORAL 040461-001 Feb 11, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MERCAPTOPURINE mercaptopurine TABLET;ORAL 040528-001 Feb 13, 2004 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan MERCAPTOPURINE mercaptopurine TABLET;ORAL 040594-001 Jul 1, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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