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Last Updated: September 29, 2020

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METHADONE HYDROCHLORIDE Drug Profile

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

Methadone Hydrochloride is a drug marketed by Hikma, Specgx Llc, Vistapharm, Akorn, Mylan Institutional, Mallinckrodt Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Epic Pharma Llc, Nostrum Labs Inc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc. and is included in twenty-six NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Methadone Hydrochloride

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

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Drug patent expirations by year for METHADONE HYDROCHLORIDE
Drug Prices for METHADONE HYDROCHLORIDE

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Recent Clinical Trials for METHADONE HYDROCHLORIDE

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SponsorPhase
National Institute of Drug AbusePhase 2
Ho Chi Minh City CDCPhase 2
The Wistar InstitutePhase 2

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Pharmacology for METHADONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for METHADONE HYDROCHLORIDE

US Patents and Regulatory Information for METHADONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 208305-002 Mar 30, 2018 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
Thepharmanetwork Llc METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 090635-001 Nov 25, 2009 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

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