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FDA Orange Book · active-ingredient family

Metyrosine

Metyrosine: 1 brand, 3 generics; first approved Jul 24, 2020; generic available.

Generic available
Generic status & protection

Generic available — 3 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
4
Originator applications

Brand (NDA) products

DEMSERRLDRS
NDA 017871—
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
250MGCAPSULEORALRxAB
Abbreviated applications

Generic (ANDA) products (3)

METYROSINE
ANDA 2186202025
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
250MGCAPSULEORALRxAB
METYROSINE
ANDA 2155412024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
250MGCAPSULEORALRxAB
METYROSINE
ANDA 2137342020
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
250MGCAPSULEORALRxAB
Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval
Jul 24, 2020
6 yr 1 mo ago
Most recent approval
Apr 09, 2025
1 yr 3 mo ago

Approvals span 2020–2025 across 4 FDA applications.

Brand (NDA) 125%
Generic (ANDA) 375%

Metyrosine — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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