FDA Orange Book
Generic for Bepreve
Bepreve contains bepotastine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Bepreve is bepotastine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Bepreve products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 1.5% | Marketed (Rx) | AT | 3 | AT |
NDA 022288, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bepotastine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 206220 | AT (A-rated, therapeutically equivalent) | March 18, 2019 | 1.5% |
| ALEMBIC PHARMACEUTICALS LTD | 214588 | AT (A-rated, therapeutically equivalent) | April 5, 2023 | 1.5% |
| SOMERSET THERAPEUTICS LLC | 217770 | AT (A-rated, therapeutically equivalent) | August 14, 2024 | 1.5% |
Bepreve NDC codes
Questions
Is there a generic for Bepreve?
Yes. The generic name for Bepreve is bepotastine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Bepreve?
The active ingredient in Bepreve is bepotastine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.