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Last Updated: January 25, 2021

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Methamphetamine hydrochloride - Generic Drug Details

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

Methamphetamine hydrochloride is the generic ingredient in three branded drugs marketed by Recordati Rare, Teva, Able, Hikma, Mayne Pharma Inc, and Rexar, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for methamphetamine hydrochloride. Three suppliers are listed for this compound.

Recent Clinical Trials for methamphetamine hydrochloride

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

SponsorPhase
San Francisco Department of Public HealthPhase 1
University of ChicagoEarly Phase 1
University of California, Los AngelesEarly Phase 1

See all methamphetamine hydrochloride clinical trials

US Patents and Regulatory Information for methamphetamine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva METHAMPEX methamphetamine hydrochloride TABLET;ORAL 083889-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Teva METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 086359-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Recordati Rare DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 091189-001 Apr 21, 2010 AA RX No No   Start Trial   Start Trial   Start Trial
Recordati Rare DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Able METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 040529-001 Feb 25, 2004 DISCN No No   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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