Viewing data from:

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Robert van Osdel FDA-2023-P-0591 · 3 docket documents Robert van Osdel, a regulatory affairs consultant, filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine a nalmefene hydrochloride injectable pharmaceutical product in a pre-filled syringe containing 1 mg/1 mL is suitable for mark	Other	2023-02-27	Withdrawn	Robert van Osdel
Citizen Petition from Nirsum Pharmaceuticals, LLC FDA-2017-P-2044 · 16 docket documents Nirsum Pharmaceuticals, LLC filed this petition under 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine whether Revex (nalmefene hydrochloride injection) in strengths of 0.1 mg base/ml and 1.0 mg base/ml, subject of NDA 020-459, was withdrawn fro	505(q)	2017-04-04	Denied	Nirsum Pharmaceuticals, LLC

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

Clinical Trials

22 trials from ClinicalTrials.gov, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence NCT00811941	Phase 3	Completed	H. Lundbeck A/S	665	2009-03 → 2010-11
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)NCT02364947	Phase 3	Completed	Otsuka Pharmaceutical Co., Ltd.	678	2015-02-09 → 2016-07-30
Efficacy of Nalmefene in Patients With Alcohol Dependence NCT00812461	Phase 3	Completed	H. Lundbeck A/S	678	2009-03 → 2011-04
Patient Driven Recovery With Nalmefene and Coaching NCT03279562	Phase 1	Completed	Yale University	10	2017-09-01 → 2019-12-30
Nalmefene Smoking Cessation Study NCT00202696	Phase 2	Completed	Somaxon Pharmaceuticals	76	2005-09 → 2006-03
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use NCT02197598	Phase 4	Completed	H. Lundbeck A/S	45	2014-09
Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge NCT01969617	Phase 1	Completed	H. Lundbeck A/S	22	2013-11
Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation NCT02639273	Phase 1	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	13	2016-06-08 → 2023-12-08
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene NCT03278886	Phase 1/2	Completed	Boston Medical Center	11	2018-07-03 → 2018-12-19
Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling NCT00132119	Phase 2/3	Completed	Somaxon Pharmaceuticals	233	2005-08 → 2006-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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