FDA Orange Book · active-ingredient family
Bepotastine besilate
Bepotastine besilate: 1 brand, 4 generics; first approved Sep 08, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- BAUSCH AND LOMB INCNDA 0222882009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5% SOLUTION/DROPS OPHTHALMIC Rx AT
Generic (ANDA) products (4)
Abbreviated applications
- BEPOTASTINE BESILATESOMERSET THERAPS LLCANDA 2177702024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5% SOLUTION/DROPS OPHTHALMIC Rx AT - BEPOTASTINE BESILATEALEMBICANDA 2145882023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5% SOLUTION/DROPS OPHTHALMIC Rx AT - BEPOTASTINE BESILATEMYLANANDA 2062202019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5% SOLUTION/DROPS OPHTHALMIC Rx AT - BEPOTASTINE BESILATEAPOTEXANDA 2060662019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5% SOLUTION/DROPS OPHTHALMIC 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
17 yr 2 mo ago
Most recent approval
2 yr 1 mo ago
Approvals span 2009–2024 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Bepotastine besilate: 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.
