Is there a generic for Timolol?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Timolol, referencing the brand BETIMOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Timolol?

BETIMOL (NDA 020439, THEA PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Timolol are approved?

Timolol is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Timolol

Timolol is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BETIMOL · NDA 020439

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
BETIMOLRLD×2	THEA PHARMA	NDA 020439	—	Mar 31, 1995

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
TIMOLOL	SOMERSET	ANDA 216654	AT	Oct 10, 2024
TIMOLOL×2	EPIC PHARMA LLC	ANDA 205309	—	Sep 30, 2016

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Timolol — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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