FDA Orange Book · active-ingredient family
Exemestane
Exemestane: 1 brand, 11 generics; first approved Oct 21, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
11
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- PFIZERNDA 0207531999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB
Generic (ANDA) products (11)
Abbreviated applications
- EXEMESTANEEUGIA PHARMAANDA 2164542022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - EXEMESTANEQILUANDA 2135472020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - EXEMESTANEDR REDDYS LABS SAANDA 2087642019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - EXEMESTANEBRECKENRIDGEANDA 2110312019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - EXEMESTANEAMNEAL PHARMSANDA 2064212018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - EXEMESTANEZYDUS PHARMSANDA 2026022018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - EXEMESTANECIPLAANDA 2103232018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - EXEMESTANEUPSHER SMITH LABSANDA 2092082017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - EXEMESTANERISINGANDA 2033152017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - EXEMESTANEALVOGENANDA 2008982014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - EXEMESTANEHIKMAANDA 0774312011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued —
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
27 yr 3 mo ago
Most recent approval
4 yr 4 mo ago
Approvals span 1999–2022 across 12 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1192%
Exemestane: 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.
