FDA Orange Book · active-ingredient family
Clomiphene citrate
Clomiphene citrate: 2 brands, 7 generics; first approved Mar 22, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
7
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
Generic (ANDA) products (7)
Abbreviated applications
- CLOMIPHENE CITRATEASCENT PHARMS INCANDA 2206732026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - CLOMIPHENE CITRATENOVITIUM PHARMAANDA 2197812025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - CLOMIPHENE CITRATEACCORD HLTHCAREANDA 2194062025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - CLOMIPHENE CITRATERUBICON RESEARCHANDA 2165452024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - CLOMIPHENE CITRATEAPPCOANDA 2167392024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - CLOMIPHENE CITRATERSCOSETTEANDA 0755281999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - GRANATA BIO CORPANDA 0721961988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
45 yr ago
Most recent approval
3 mo ago
Approvals span 1982–2026 across 9 FDA applications.
Brand (NDA) 222%
Generic (ANDA) 778%
Clomiphene citrate: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
