Last Updated: July 7, 2026

METHADONE Drug Patent Profile

Name: METHADONE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Methadone patents expire, and what generic alternatives are available?

Methadone is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Breckenridge, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc. and is included in twenty-nine NDAs.

The generic ingredient in METHADONE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Methadone

A generic version of METHADONE was approved as methadone hydrochloride by HIKMA on March 8^th, 1983.

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Summary for METHADONE

US Patents:	0
Applicants:	15
NDAs:	29
Drug Prices:	Drug price information for METHADONE
DailyMed Link:	METHADONE at DailyMed

Drug patent expirations by year for METHADONE

US Patents and Regulatory Information for METHADONE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vistapharm Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	204166-001	Mar 16, 2020	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Roxane	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	074081-001	Apr 28, 1995		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Epic Pharma Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	090065-001	Aug 18, 2015	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Specgx Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	040517-001	Apr 27, 2004	AA	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

DrugChatter Q&A for METHADONE

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.