FDA Orange Book
Generic for Demser
Demser contains metyrosine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Demser is metyrosine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Demser products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Marketed (Rx) | AB | 3 | AB |
NDA 017871, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metyrosine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 213734 | AB (A-rated, therapeutically equivalent) | July 24, 2020 | 250MG |
| LEADING PHARMA LLC | 215541 | AB (A-rated, therapeutically equivalent) | September 17, 2024 | 250MG |
| DR REDDYS LABORATORIES SA | 218620 | AB (A-rated, therapeutically equivalent) | April 9, 2025 | 250MG |
Demser NDC codes
Questions
Is there a generic for Demser?
Yes. The generic name for Demser is metyrosine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Demser?
The active ingredient in Demser is metyrosine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.