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REVIA

NDA

NALTREXONE HYDROCHLORIDE | N018932 | TEVA WOMENS HEALTH 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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5194 · 7 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, suitable for submission as an ANDA, with the Ref	Suitability	2026-05-11	Open	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-4151 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that FDA determine whether ReVia (naltrexone HCl) Tablets, 50 mg, approved under NDA 018932 and held by Teva Women's Health, Inc., was withdrawn for reasons of safety or effectiveness. The petitioner contends the drug was disconti	Other	2025-09-23	Denied	Hyman, Phelps & McNamara, P.C.

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

Clinical Trials

282 trials from ClinicalTrials.gov — 1 recruiting, 239 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Opioids and Social Support Enhanced Extinction Effects NCT04166071	Early Phase 1	By Invitation	University of California, Los Angeles	60	2021-12-13 → 2026-09
Naltrexone for Early Problem Drinkers NCT00000455	Phase 4	Completed	UConn Health	160	— → 2002-09
The Effect of Regular Naltrexone Dosing on Disordered Gamblers NCT02537197	Phase 1	Completed	University of Calgary	35	2016-04 → 2022-05-26
Double-Blind Naltrexone in Kleptomania NCT00332579	Phase 2	Completed	University of Minnesota	25	2006-05-01 → 2008-09-01
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment NCT00938886	Phase 2	Completed	Brown University	150	2009-10 → 2015-12
Medication-Assisted Treatment for Youth With Substance Use Disorders NCT02593474	Phase 1	Completed	New York State Psychiatric Institute	11	2015-09 → 2018-04
Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)NCT00453609	Phase 4	Completed	State University of New York - Upstate Medical University	15	2007-04 → 2008-10
Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention NCT01528007	Phase 4	Completed	Finnish Institute for Health and Welfare	100	2011-01 → 2013-09
Biomarkers of Injectable Extended Release Naltrexone Treatment NCT02324725	Phase 4	Completed	University of Pennsylvania	32	2011-10 → 2021-12
Trial of Naltrexone and Dextromethorphan for Gulf War Illness NCT02206490	Phase 2	Completed	East Carolina University	60	2012-01 → 2016-01

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

API Supply Chain9 active DMFs

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

ASPEN OSS BVNALTREXONE HYDROCHLORIDE

DMF 151022000

FRANCOPIA A EUROAPI CONALTREXONE HYDROCHLORIDE

DMF 206232007

SUN PHARMACEUTICAL INDUSTRIES LTDNALTREXONE HYDROCHLORIDE USP (DIHYDRATE FORM)

DMF 212172007

MACFARLAN SMITH LTDNALTREXONE HYDROCHLORIDE

DMF 215902008

SIEGFRIED LTDNALTREXONE HYDROCHLORIDE

DMF 232142009

NORAMCO LLCNALTREXONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 233252009

SUN PHARMACEUTICAL INDUSTRIES LTDNALTREXONE HYDROCHLORIDE USP (DIHYDRATE FORM) (PROCESS-II)

DMF 365602022

SANECA PHARMACEUTICALS ASNALTREXONE HYDROCHLORIDE

DMF 412642025

STHREE CHEMICALS PRIVATE LTDNALTREXONE HYDROCHLORIDE USP

DMF 424342025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 4, 2013	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 20, 1984

No patent or exclusivity listings for this strength.