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REVEX

NDA

NALMEFENE HYDROCHLORIDE | N020459 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs3 inactive

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

SPECGX LLCNALMEFENE HYDROCHLORIDE

DMF 156632001

RUSAN PHARMA LTDNALMEFENE HYDROCHLORIDE

DMF 343672019

SICHUAN QINGMU PHARMACEUTICAL CO LTDNALMEFENE HYDROCHLORIDE

DMF 367512022

PURISYS LLCNALMEFENE HYDROCHLORIDE DRUG SUBSTANCE

DMF 397672024

SANOFI SAInactiveNALMEFENE HYDROCHLORIDE

DMF 54841984

NV ORGANONInactiveNALMEFENE HYDROCHLORIDE

DMF 56421984

TASMANIAN ALKALOIDS PROPRIETARY LTDInactiveNALMEFENE HYDROCHLORIDE

DMF 85071990

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 13, 2006	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Apr 17, 1995

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Apr 17, 1995