FDA Orange Book · active-ingredient family
Clomiphene citrate
Clomiphene citrate is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CLOMID · NDA 016131
2
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOMIPHENE CITRATE | ASCENT PHARMS INC | ANDA 220673 | AB | May 15, 2026 | |
| CLOMIPHENE CITRATE | NOVITIUM PHARMA | ANDA 219781 | AB | Oct 17, 2025 | |
| CLOMIPHENE CITRATE | ACCORD HLTHCARE | ANDA 219406 | AB | Oct 03, 2025 | |
| CLOMIPHENE CITRATE | RUBICON RESEARCH | ANDA 216545 | AB | Nov 12, 2024 | |
| CLOMIPHENE CITRATE | APPCO | ANDA 216739 | AB | Nov 08, 2024 | |
| CLOMIPHENE CITRATE | COSETTE | ANDA 075528 | AB | Aug 30, 1999 | |
| MILOPHENE | GRANATA BIO CORP | ANDA 072196 | AB | Dec 20, 1988 |
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.
Clomiphene citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
