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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 Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, suitable for submission as an ANDA, with the Reference Listed Drug being Teva Women's He	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whether ReVia (naltrexone HCl) Tablets, 50 mg, approved under NDA 018932 and held by Teva Women's Health, Inc., was withdrawn for reasons of safety or effectiveness.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	DeniedDecision letter not yet read	Hyman, Phelps & McNamara, P.C.

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

Clinical Trials

295 trials from ClinicalTrials.gov — 9 recruiting, 2 active, 241 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)NCT04464980	Phase 2	Active	NYU Langone Health	1,516	2021-06-08 → 2027-01-31
Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder NCT06233799	Phase 3	Active	National Institute on Drug Abuse (NIDA)	360	2024-07-01 → 2027-04-30
Opioids and Social Support Enhanced Extinction Effects NCT04166071	Early Phase 1	By Invitation	University of California, Los Angeles	60	2021-12-13 → 2026-09
Combination Therapy for Alcohol Use Disorder NCT07249554	Phase 2	Not Yet Recruiting	Johns Hopkins University	45	2026-09 → 2028-09
Low-Dose Naltrexone For ME/CFS: Dose-Finding NCT07285473	Phase 2	Not Yet Recruiting	University of Alabama at Birmingham	75	2026-10-01 → 2028-04-01
Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients NCT07224087	Phase 1	Not Yet Recruiting	Medical University of South Carolina	20	2026-09-01 → 2027-12-31
Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)NCT07224009	Phase 2	Not Yet Recruiting	University of Arkansas	60	2026-08 → 2030-01
A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients NCT07398404	Phase 1/2	Not Yet Recruiting	Medical University of South Carolina	64	2026-09-01 → 2031-06-30
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers NCT07064564	Phase 1	Recruiting	Akyso Therapeutics, LLC	33	2026-07-25 → 2029-12-31
Emergency Department-Initiated Medications for Alcohol Use Disorder NCT05827159	Phase 3	Recruiting	Yale University	240	2024-08-17 → 2029-02-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

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.