Is there a generic for Metyrosine?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Metyrosine, referencing the brand DEMSER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Metyrosine?

DEMSER (NDA 017871, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Metyrosine are approved?

Metyrosine is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Metyrosine

Metyrosine is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DEMSER · NDA 017871

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
DEMSERRLD	BAUSCH	NDA 017871	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
METYROSINE	DR REDDYS LABS SA	ANDA 218620	AB	Apr 09, 2025
METYROSINE	LEADING	ANDA 215541	AB	Sep 17, 2024
METYROSINE	AMNEAL	ANDA 213734	AB	Jul 24, 2020

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Metyrosine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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