METHADONE Drug Patent Profile

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.

Summary for METHADONE

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

See drug prices for METHADONE

US Patents and Regulatory Information for METHADONE

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
Roxane	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	074081-001	Apr 28, 1995		DISCN	No	No
Epic Pharma Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	090065-001	Aug 18, 2015	AA	RX	No	No
Specgx Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	040517-001	Apr 27, 2004	AA	RX	No	Yes
Epic Pharma Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	090065-002	Aug 18, 2015	AA	RX	No	No
Hikma	METHADONE HYDROCHLORIDE	methadone hydrochloride	CONCENTRATE;ORAL	040180-001	Apr 30, 1998	AA	RX	No	No