FDA Orange Book

Generic for Prolensa

Prolensa 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 Prolensa is bromfenac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Prolensa products in the Orange Book

Prolensa products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution/drops, ophthalmic	EQ 0.07% ACID	Marketed (Rx)	AB	4	AB

NDA 203168, 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 bromfenac

Approved generic versions of Prolensa
Company	ANDA	TE code	Approved	Strengths
LUPIN LTD	206027	AB (A-rated, therapeutically equivalent)	November 22, 2023	EQ 0.07% ACID
ALEMBIC PHARMACEUTICALS LTD	214340	AB (A-rated, therapeutically equivalent)	July 8, 2024	EQ 0.07% ACID
APOTEX INC	207334	AB (A-rated, therapeutically equivalent)	July 8, 2024	EQ 0.07% ACID
AMNEAL EU LTD	210962	AB (A-rated, therapeutically equivalent)	July 29, 2024	EQ 0.07% ACID

Prolensa patents

Patents listed for Prolensa
Patent	Expires	Covers	Use code	NDA
10085958	November 19, 2032	Drug product	None	203168
9517220	November 11, 2033	Method of use	U-1933	203168

Prolensa NDC codes

Questions

Is there a generic for Prolensa?

Yes. The generic name for Prolensa is bromfenac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Prolensa?

The active ingredient in Prolensa is bromfenac, per the FDA Orange Book.

When does the Prolensa patent expire?

The last patent listed for Prolensa in the Orange Book expires November 11, 2033. 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.