FDA Orange Book
Generic for Bromsite
Bromsite contains bromfenac. 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 Bromsite is bromfenac. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Bromsite products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 0.075% ACID | Marketed (Rx) | AB | 1 | AB |
NDA 206911, held by SUN PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bromfenac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 211239 | AB (A-rated, therapeutically equivalent) | February 2, 2024 | EQ 0.075% ACID |
Bromsite patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE50218 | March 5, 2029 | Drug product | U-1834 | 206911 |
Bromsite NDC codes
Questions
Is there a generic for Bromsite?
Yes. The generic name for Bromsite is bromfenac. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Bromsite?
The active ingredient in Bromsite is bromfenac, per the FDA Orange Book.
When does the Bromsite patent expire?
The last patent listed for Bromsite in the Orange Book expires March 5, 2029. A listed patent expiry date is not a generic launch date.
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.