Is there a generic for Dorzolamide hydrochloride; timolol maleate?

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Dorzolamide hydrochloride; timolol maleate, referencing the brand COSOPT PF. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dorzolamide hydrochloride; timolol maleate?

COSOPT PF (NDA 202667, 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 Dorzolamide hydrochloride; timolol maleate are approved?

Dorzolamide hydrochloride; timolol maleate is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Dorzolamide hydrochloride; timolol maleate

Dorzolamide hydrochloride; timolol maleate is approved as 2 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:COSOPT PF · NDA 202667

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
COSOPT PFRLD	THEA PHARMA	NDA 202667	AT2	Feb 01, 2012
COSOPTRLD	THEA PHARMA	NDA 020869	AT1	Apr 07, 1998

Generic (ANDA) products (20)

Product	Applicant	Application	TE	Approved
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	ALEMBIC THERAP	ANDA 216308	AT2	Feb 18, 2025
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	INGENUS PHARMS LLC	ANDA 217260	AT2	May 01, 2023
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	GLAND	ANDA 215520	AT1	Sep 19, 2022
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	MICRO LABS	ANDA 215936	AT2	Jan 25, 2022
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EUGIA PHARMA	ANDA 207629	AT1	May 14, 2021
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	ALEMBIC	ANDA 213099	AT1	May 04, 2021
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	MICRO LABS	ANDA 204777	AT1	May 28, 2020
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	SOMERSET	ANDA 207523	AT1	Jun 25, 2019
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	FDC LTD	ANDA 205295	AT1	Jun 13, 2019
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EUGIA PHARMA	ANDA 207630	AT2	Jul 24, 2018
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	CHARTWELL MOLECULAR	ANDA 201998	—	Dec 17, 2014
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EPIC PHARMA LLC	ANDA 203058	AT1	Sep 22, 2014
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	REGCON HOLDINGS	ANDA 202054	AT1	Sep 03, 2014
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	ZAMBON SPA	ANDA 091180	—	Dec 04, 2013
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	SANDOZ	ANDA 090604	AT1	Nov 18, 2009
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	TEVA PHARMS	ANDA 078704	—	Sep 28, 2009
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	BAUSCH AND LOMB	ANDA 090037	AT1	Jul 14, 2009
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	SANDOZ	ANDA 078749	AT1	Nov 06, 2008
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	HIKMA	ANDA 077847	—	Oct 28, 2008
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	RUBICON RESEARCH	ANDA 078201	—	Oct 28, 2008

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.

Dorzolamide hydrochloride; timolol maleate — frequently asked questions

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

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