FDA Orange Book

Generic for Combigan

Combigan contains brimonidine and timolol. 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 Combigan is brimonidine and timolol. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Combigan products in the Orange Book

Combigan products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution/drops, ophthalmic	0.2%;EQ 0.5% BASE	Marketed (Rx)	AB	11	AB

NDA 021398, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic brimonidine and timolol

Approved generic versions of Combigan
Company	ANDA	TE code	Approved	Strengths
SANDOZ INC	091087	AB (A-rated, therapeutically equivalent)	April 4, 2022	0.2%;EQ 0.5% BASE
APOTEX INC	091442	AB (A-rated, therapeutically equivalent)	April 20, 2022	0.2%;EQ 0.5% BASE
REGCON HOLDINGS LLC	201949	AB (A-rated, therapeutically equivalent)	October 4, 2022	0.2%;EQ 0.5% BASE
SENTISS AG	091086	AB (A-rated, therapeutically equivalent)	October 31, 2022	0.2%;EQ 0.5% BASE
UPSHER SMITH LABORATORIES LLC	215598	AB (A-rated, therapeutically equivalent)	December 12, 2022	0.2%;EQ 0.5% BASE
ALEMBIC PHARMACEUTICALS LTD	215230	AB (A-rated, therapeutically equivalent)	August 25, 2023	0.2%;EQ 0.5% BASE
GLENMARK PHARMACEUTICALS LTD	214987	AB (A-rated, therapeutically equivalent)	May 16, 2024	0.2%;EQ 0.5% BASE
SOMERSET THERAPEUTICS LLC	216114	AB (A-rated, therapeutically equivalent)	September 10, 2024	0.2%;EQ 0.5% BASE
CAPLIN STERILES LTD	219093	AB (A-rated, therapeutically equivalent)	February 25, 2025	0.2%;EQ 0.5% BASE
GLAND PHARMA LTD	219166	AB (A-rated, therapeutically equivalent)	June 11, 2026	0.2%;EQ 0.5% BASE
SABA ILAC SANAYIVE TICARET AS	217934	AB (A-rated, therapeutically equivalent)	July 1, 2026	0.2%;EQ 0.5% BASE

Combigan NDC codes

0023-9211

Questions

Is there a generic for Combigan?

Yes. The generic name for Combigan is brimonidine and timolol. 11 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 Combigan?

The active ingredient in Combigan is brimonidine and timolol, 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.