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Last Updated: March 29, 2024

Methadone hydrochloride - Generic Drug Details


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What are the generic sources for methadone hydrochloride and what is the scope of freedom to operate?

Methadone hydrochloride is the generic ingredient in five branded drugs marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Sandoz, 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

SponsorPhase
Het Zwarte GatPhase 2
Radboud University Medical CenterPhase 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 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

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
Hikma METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087997-001 Aug 30, 1982 AA RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 203502-002 Aug 31, 2015 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma DOLOPHINE HYDROCHLORIDE methadone hydrochloride SYRUP;ORAL 006134-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc METHADOSE methadone hydrochloride TABLET, FOR SUSPENSION;ORAL 074184-001 Apr 29, 1993 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Inc METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc METHADOSE methadone hydrochloride TABLET;ORAL 040050-001 Apr 15, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 074081-001 Apr 28, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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