FDA Orange Book · active-ingredient family
Candesartan cilexetil
Candesartan cilexetil: 1 brand, 7 generics; first approved Jun 04, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
27
Brand (NDA) products
Originator applications
- ATACANDRLDANI PHARMSNDA 02083819984 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB 32MG TABLET ORAL Rx AB
Generic (ANDA) products (7)
Abbreviated applications
- CANDESARTAN CILEXETILPRINSTON INCANDA 20623320233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB 32MG TABLET ORAL Rx AB - CANDESARTAN CILEXETILALEMBICANDA 21030220183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB - CANDESARTAN CILEXETILZYDUS LIFESCIENCESANDA 09139020174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB 32MG TABLET ORAL Rx AB - CANDESARTAN CILEXETILALEMBICANDA 2091192017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 32MG TABLET ORAL Rx AB - CANDESARTAN CILEXETILMACLEODS PHARMS LTDANDA 20381320164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB 32MG TABLET ORAL Rx AB - CANDESARTAN CILEXETILAPOTEXANDA 20207920144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — 8MG TABLET ORAL Discontinued — 16MG TABLET ORAL Discontinued — 32MG TABLET ORAL Discontinued — - CANDESARTAN CILEXETILMYLANANDA 07870220134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB 32MG 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
28 yr 7 mo ago
Most recent approval
3 yr ago
Approvals span 1998–2023 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Candesartan cilexetil: 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.
