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Last Updated: May 20, 2024

Dorzolamide hydrochloride - Generic Drug Details


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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. Eleven suppliers are listed for this compound.

Summary for dorzolamide hydrochloride
Recent Clinical Trials for dorzolamide hydrochloride

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

SponsorPhase
Laboratorios PoenPhase 4
Shahid Beheshti University of Medical SciencesPhase 2/Phase 3
Salus UniversityPhase 4

See all dorzolamide hydrochloride clinical trials

Pharmacology for dorzolamide hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for dorzolamide hydrochloride
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
Rubicon DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 078201-001 Oct 28, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ingenus Pharms Llc DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 217260-001 May 1, 2023 AT2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 090143-001 Jun 25, 2009 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck TRUSOPT dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 020408-001 Dec 9, 1994 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 203058-001 Sep 22, 2014 AT1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 212639-001 Aug 9, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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