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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

3 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amendment to Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2026-P-5875 Felix Pharmaceuticals Pvt. Ltd. filed an amendment to a suitability petition regarding Galliprant (grapiprant tablets) 20 mg, 60 mg, and 100 mg, a prostaglandin E2 EP4 receptor antagonist non-steroidal anti-inflammatory drug for oral use in dogs with osteoarthritis, marketed by Elanco US Inc. The pe	Suitability	2026-06-16	Open	Felix Pharmaceuticals Pvt. Ltd.
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5194 Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, suitable for an ANDA, with the 50 mg	Suitability	2026-05-11	Open	Hyman
Background Material re Citizen Petition from Ortho-McNeil, Inc. - Attachment ... FDA-2007-P-0065 This document is background material referenced in a citizen petition from Ortho-McNeil, Inc. regarding abbreviated new drug applications, specifically citing a proposed rule published in the Federal Register on July 10, 1989. The attachment consists of the proposed rule text itself concerning ANDAs	Other	2008-04-14	Denied	Ortho-McNeil

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

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

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.