DORZOLAMIDE HYDROCHLORIDE Drug Patent Profile

Which patents cover Dorzolamide Hydrochloride, and what generic alternatives are available?

Dorzolamide Hydrochloride is a drug marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset. and is included in thirty-two NDAs.

The generic ingredient in DORZOLAMIDE HYDROCHLORIDE is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dorzolamide Hydrochloride

A generic version of DORZOLAMIDE HYDROCHLORIDE was approved as dorzolamide hydrochloride; timolol maleate by SANDOZ on November 6^th, 2008.

Summary for DORZOLAMIDE HYDROCHLORIDE

US Patents:	0
Applicants:	17
NDAs:	32
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	56
Patent Applications:	385
DailyMed Link:	DORZOLAMIDE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DORZOLAMIDE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Laboratorios Poen	Phase 4
Shahid Beheshti University of Medical Sciences	Phase 2/Phase 3
Salus University	Phase 4

See all DORZOLAMIDE HYDROCHLORIDE clinical trials

Pharmacology for DORZOLAMIDE HYDROCHLORIDE

Drug Class	Carbonic Anhydrase Inhibitor
Mechanism of Action	Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DORZOLAMIDE HYDROCHLORIDE

S01EC	Carbonic anhydrase inhibitors
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUSOPT	Ophthalmic Solution	dorzolamide hydrochloride	2%	020408	1	2005-10-11

US Patents and Regulatory Information for DORZOLAMIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zambon Spa	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	091180-001	Dec 4, 2013		DISCN	No	No
Sandoz	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	078749-001	Nov 6, 2008	AT1	RX	No	No
Sandoz	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	090604-001	Nov 18, 2009	AT1	RX	No	No
Alembic	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212639-001	Aug 9, 2019	AT	RX	No	No
Eugia Pharma	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	207629-001	May 14, 2021	AT1	RX	No	No
Ingenus Pharms Llc	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	217260-001	May 1, 2023	AT2	RX	No	No
Indoco	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202053-001	Sep 11, 2014	AT	RX	No	No