FDA Orange Book

Generic for Timoptic-XE

Timoptic-XE 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-XE is timolol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Timoptic-XE products in the Orange Book

Timoptic-XE products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, gel forming/drops, ophthalmic	EQ 0.25% BASE	Marketed (Rx)	AB	4	AB
solution, gel forming/drops, ophthalmic	EQ 0.5% BASE	Marketed (Rx)	AB	5	AB

NDA 020330, 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-XE
Company	ANDA	TE code	Approved	Strengths
ALEMBIC PHARMACEUTICALS LTD	212942	AB (A-rated, therapeutically equivalent)	October 22, 2020	EQ 0.25% BASE, EQ 0.5% BASE
GLAND PHARMA LTD	214645	AB (A-rated, therapeutically equivalent)	June 24, 2022	EQ 0.25% BASE, EQ 0.5% BASE
DR REDDYS LABORATORIES LTD	215733	AB (A-rated, therapeutically equivalent)	September 22, 2022	EQ 0.25% BASE, EQ 0.5% BASE
EUGIA PHARMA SPECIALITIES LTD	213540	AB (A-rated, therapeutically equivalent)	March 23, 2023	EQ 0.5% BASE
SOMERSET THERAPEUTICS LLC	210640	AB (A-rated, therapeutically equivalent)	September 16, 2024	EQ 0.25% BASE, EQ 0.5% BASE

Timoptic-XE NDC codes

Questions

Is there a generic for Timoptic-XE?

Yes. The generic name for Timoptic-XE is timolol. 5 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 Timoptic-XE?

The active ingredient in Timoptic-XE 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.