FDA Orange Book
Generic for Minirin
Minirin contains desmopressin acetate. 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 Minirin is desmopressin acetate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Minirin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.01MG/SPRAY | Discontinued | None | 2 | AB |
NDA 021333, held by FERRING PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic desmopressin acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 076703 | AB (A-rated, therapeutically equivalent) | January 27, 2005 | 0.01MG/SPRAY |
| ZYDUS PHARMACEUTICALS USA INC | 091345 | AB (A-rated, therapeutically equivalent) | October 3, 2017 | 0.01MG/SPRAY |
Questions
Is there a generic for Minirin?
Yes. The generic name for Minirin is desmopressin acetate. 2 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 Minirin?
The active ingredient in Minirin is desmopressin acetate, 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.