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METHADONE HYDROCHLORIDE

NDA

METHADONE HYDROCHLORIDE | N017058 | HIKMA PHARMACEUTICALS USA 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2002-P-0528 · 5 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Methadone Hydrochloride Tablets in 15 mg, 20 mg, and 30 mg strengths suitable for abbreviated new drug applications, citing the 40 mg strength approved under NDA 17-058 as the referenc	Other	2017-09-20	Open	Lachman Consultant Services, Inc.

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

Clinical Trials

137 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 95 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)NCT04214834	Phase 3	Active	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program	189	2020-09-28 → 2026-06-30
Methadone and Quality of Postoperative Recovery NCT03168958	Phase 4	Recruiting	Endeavor Health	130	2018-12-25 → 2021-07-25
Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery NCT03893734	Phase 4	Recruiting	Endeavor Health	140	2018-05-01 → 2020-12-23
Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy NCT03574792	Phase 2	Completed	Roswell Park Cancer Institute	62	2018-05-03 → 2021-11-11
Cognitive Function and Pain Threshold in People Who Are Methadone Maintained NCT04027166	Early Phase 1	Completed	Yale University	27	2019-07-01 → 2021-04-28
Epidural Methadone in Healthy Volunteers NCT03525509	Early Phase 1	Completed	simon.haroutounian	13	2018-06-04 → 2019-08-30
Combined Behavioral and Pharmacologic Treatment of Polydrug Abuse NCT00292123	Phase 1	Completed	National Institute on Drug Abuse (NIDA)	200	1999-06 → 2006-08
A Laboratory Model for Heroin Abuse Medications - 8 NCT00000273	Phase 2	Completed	New York State Psychiatric Institute	8	1995-08 → 2005-11
Starting Treatment With Agonist Replacement Therapies (START)NCT00315341	Phase 4	Completed	University of California, Los Angeles	1,269	2006-04 → 2010-08
IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction NCT01205256	Phase 3	Completed	University of Virginia	11	2009-03 → 2010-04

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$12.82

Highest Price

$12.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-4538-25METHADONE HCL 40MG DISKETS	$12.82	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
00054-4538-25METHADONE HCL 40MG DISKETS	$12.82	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain3 active DMFs3 inactive

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

SIEGFRIED USA LLCMETHADONE HYDROCHLORIDE USP

DMF 62311986

CHATTEM CHEMICALS INCMETHADONE HYDROCHLORIDE USP

DMF 252862012

SPECGX LLCMETHADONE HYDROCHLORIDE USP

DMF 293502015

MALLINCKRODT INCInactiveMETHADONE HYDROCHLORIDE

DMF 15151970

ADAMHA NIDAInactiveMETHADONE

DMF 22241974

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMETHADONE HYDROCHLORIDE USP

DMF 139421999

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -29	View Letter (PDF)
Dec 19, 2023	SUPPL -28	View Letter (PDF)
Jun 3, 2021	SUPPL -27	View Letter (PDF)
Oct 8, 2019	SUPPL -26	View Letter (PDF)
Feb 2, 2018	SUPPL -25	View Letter (PDF)
Dec 19, 2016	SUPPL -23	View Letter (PDF)
Dec 19, 2016	SUPPL -22	View Letter (PDF)
Sep 20, 2013	SUPPL -21	View Letter (PDF)
Feb 7, 2008	SUPPL -19	View Letter (PDF)
Dec 28, 2006	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

RLDAA

0 patents0 exclusivities▴

TABLET, FOR SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.