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Last Updated: March 28, 2024

Metyrosine - Generic Drug Details


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What are the generic drug sources for metyrosine and what is the scope of freedom to operate?

Metyrosine is the generic ingredient in two branded drugs marketed by Bausch and Amneal, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for metyrosine. Three suppliers are listed for this compound.

Drug Prices for metyrosine

See drug prices for metyrosine

Recent Clinical Trials for metyrosine

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

SponsorPhase
Joseph Ahmed FoundationPhase 2
Sarcoma Oncology Research Center, LLCPhase 2
Tyme, IncPhase 2

See all metyrosine clinical trials

Pharmacology for metyrosine

US Patents and Regulatory Information for metyrosine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal METYROSINE metyrosine CAPSULE;ORAL 213734-001 Jul 24, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch DEMSER metyrosine CAPSULE;ORAL 017871-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  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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