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ALKERAN

NDA

MELPHALAN | N014691 | APOTEX 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Andrulis Pharmaceuticals Corp. v. Celgene Corp. 1:2013cv01644 23 patentsmelphalanthalidomidelenalidomide	D. Del.	2013-10-02	Terminated 2015-07-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

CHEMPACIFIC CORPMELPHALAN DRUG SUBSTANCE

DMF 200732006

CHEMWERTH INCMELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE

DMF 256442011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMELPHALAN

DMF 283002014

HUBEI HONCH PHARMACEUTICAL CO LTDMELPHALAN

DMF 385912023

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

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#002 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.