FDA Orange Book
Generic for Serophene
Serophene contains clomiphene. 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 Serophene is clomiphene. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Serophene products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 50MG | Discontinued | None | 7 | AB |
NDA 018361, held by EMD SERONO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clomiphene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GRANATA BIO CORP | 072196 | AB (A-rated, therapeutically equivalent) | December 20, 1988 | 50MG |
| COSETTE PHARMACEUTICALS INC | 075528 | AB (A-rated, therapeutically equivalent) | August 30, 1999 | 50MG |
| APPCO PHARMA LLC | 216739 | AB (A-rated, therapeutically equivalent) | November 8, 2024 | 50MG |
| RUBICON RESEARCH LTD | 216545 | AB (A-rated, therapeutically equivalent) | November 12, 2024 | 50MG |
| ACCORD HEALTHCARE INC | 219406 | AB (A-rated, therapeutically equivalent) | October 3, 2025 | 50MG |
| NOVITIUM PHARMA LLC | 219781 | AB (A-rated, therapeutically equivalent) | October 17, 2025 | 50MG |
| ASCENT PHARMACEUTICALS INC | 220673 | AB (A-rated, therapeutically equivalent) | May 15, 2026 | 50MG |
Questions
Is there a generic for Serophene?
Yes. The generic name for Serophene is clomiphene. 7 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 Serophene?
The active ingredient in Serophene is clomiphene, 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.