FDA Orange Book · active-ingredient family
Bepotastine besilate
Bepotastine besilate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BEPREVE · NDA 022288
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BEPREVERLD | BAUSCH AND LOMB INC | NDA 022288 | AT | Sep 08, 2009 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BEPOTASTINE BESILATE | SOMERSET THERAPS LLC | ANDA 217770 | AT | Aug 14, 2024 | |
| BEPOTASTINE BESILATE | ALEMBIC | ANDA 214588 | AT | Apr 05, 2023 | |
| BEPOTASTINE BESILATE | MYLAN | ANDA 206220 | AT | Mar 18, 2019 | |
| BEPOTASTINE BESILATE | APOTEX | ANDA 206066 | — | Mar 05, 2019 |
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.
Bepotastine besilate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
