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Last Updated: July 19, 2024

Methadone hydrochloride - Generic Drug Details

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What are the generic drug sources for methadone hydrochloride and what is the scope of patent protection?

Methadone hydrochloride is the generic ingredient in five branded drugs marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Sandoz, Vistapharm, Ascent Pharms Inc, Aurolife Pharma Llc, Epic Pharma Llc, Nostrum Labs Inc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for methadone hydrochloride. Eighteen suppliers are listed for this compound.

Drug Prices for methadone hydrochloride

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Recent Clinical Trials for methadone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 2
Parnassia Addiction Research CentrePhase 2
Leiden University Medical CenterPhase 2

See all methadone hydrochloride clinical trials

Pharmacology for methadone hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for methadone hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes 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
Specgx Llc METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 207368-001 Aug 22, 2019 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vistapharm Llc METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 040241-002 May 29, 1998 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz WESTADONE methadone hydrochloride TABLET, EFFERVESCENT;ORAL 017108-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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