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PURINETHOL

NDA

MERCAPTOPURINE | N009053 | STASON PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceuticals Inc FDA-2014-P-1044 Zydus Pharmaceuticals (USA), Inc. filed this citizen petition on July 14, 2014, requesting that the FDA amend the Orange Book to designate a second reference listed drug for Mercaptopurine Tablets, specifically requesting that products from Mylan and/or Roxane be designated as alternative reference	505(q)	2014-09-11	Withdrawn	Zydus Pharmaceuticals Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

AARTI PHARMALABS LTDMERCAPTOPURINE

DMF 229712009

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDMERCAPTOPURINE

DMF 268492012

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveMERCAPTOPURINE USP

DMF 165752003

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveMERCAPTOPURINE USP

DMF 168052003

BENZOCHEM LIFESCIENCES PVT LTDInactiveMERCAPTOPURINE USP

DMF 212672008

RPG LIFE SCIENCES LTDInactiveMERCAPTOPURINE USP

DMF 217582008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#002 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.