FDA Orange Book

Generic for Timoptic

Timoptic contains 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 Timoptic is timolol. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1, AT2, AT3.

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Timoptic products in the Orange Book

Timoptic products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution/drops, ophthalmic	EQ 0.25% BASE	Marketed (Rx)	AT1	8	AT1, AT3
solution/drops, ophthalmic	EQ 0.5% BASE	Marketed (Rx)	AT1	13	AT1, AT3, AT2

NDA 018086, 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 timolol

Approved generic versions of Timoptic
Company	ANDA	TE code	Approved	Strengths
SANDOZ INC	074261	AT1 (A-rated, therapeutically equivalent)	April 28, 1995	EQ 0.25% BASE
SANDOZ INC	074262	AT1 (A-rated, therapeutically equivalent)	April 28, 1995	EQ 0.5% BASE
ABBVIE INC	074746	AT1 (A-rated, therapeutically equivalent)	March 25, 1997	EQ 0.25% BASE
ABBVIE INC	074747	AT1 (A-rated, therapeutically equivalent)	March 25, 1997	EQ 0.5% BASE
FDC LTD	077259	AT1 (A-rated, therapeutically equivalent)	April 30, 2008	EQ 0.25% BASE, EQ 0.5% BASE
MANKIND PHARMA LTD	078771	AT1 (A-rated, therapeutically equivalent)	September 28, 2009	EQ 0.25% BASE, EQ 0.5% BASE
EPIC PHARMA LLC	212291	AT3 (A-rated, therapeutically equivalent)	September 11, 2020	EQ 0.5% BASE
J MOLNER HOLDINGS INC	212592	AT3 (A-rated, therapeutically equivalent)	December 13, 2021	EQ 0.25% BASE, EQ 0.5% BASE
MICRO LABS LTD	216596	AT3 (A-rated, therapeutically equivalent)	September 7, 2022	EQ 0.5% BASE
INGENUS PHARMACEUTICALS LLC	216533	AT3 (A-rated, therapeutically equivalent)	September 13, 2022	EQ 0.25% BASE, EQ 0.5% BASE
SENTISS PHARMA PRIVATE LTD	217195	AT3 (A-rated, therapeutically equivalent)	May 8, 2023	EQ 0.5% BASE
MICRO LABS LTD	217343	AT1 (A-rated, therapeutically equivalent)	May 26, 2023	EQ 0.25% BASE, EQ 0.5% BASE
SOMERSET THERAPEUTICS LLC	217764	AT1 (A-rated, therapeutically equivalent)	July 3, 2024	EQ 0.25% BASE, EQ 0.5% BASE
SOMERSET THERAPEUTICS LLC	216653	AT2 (A-rated, therapeutically equivalent)	July 3, 2024	EQ 0.5% BASE
CAPLIN STERILES LTD	218460	AT1 (A-rated, therapeutically equivalent)	August 7, 2024	EQ 0.5% BASE

Timoptic NDC codes

Questions

Is there a generic for Timoptic?

Yes. The generic name for Timoptic is timolol. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1, AT2, AT3.

What is the generic name for Timoptic?

The active ingredient in Timoptic is 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.