Dorzolamide hydrochloride - Generic Drug Details

What are the generic drug sources for dorzolamide hydrochloride and what is the scope of patent protection?

Dorzolamide hydrochloride is the generic ingredient in five branded drugs marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Msd Sub Merck, Thea Pharma, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for dorzolamide hydrochloride. Twelve suppliers are listed for this compound.

Summary for dorzolamide hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	19
NDAs:	35
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	56
Patent Applications:	587
What excipients (inactive ingredients) are in dorzolamide hydrochloride?	dorzolamide hydrochloride excipients list
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
Alembic	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	213099-001	May 4, 2021	AT1	RX	No	No
Hikma	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	077846-001	Oct 28, 2008		DISCN	No	No
Indoco	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	202054-001	Sep 3, 2014	AT1	RX	No	No
Am Regent	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	079186-001	Nov 18, 2009		DISCN	No	No
Gland Pharma Ltd	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	215520-001	Sep 19, 2022	AT1	RX	No	No
Thea Pharma	COSOPT PF	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	202667-001	Feb 1, 2012	AT2	RX	Yes	Yes
Bausch And Lomb	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	090143-001	Jun 25, 2009	AT	RX	No	No

Expired US Patents for dorzolamide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994