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Last Updated: June 19, 2021

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DORZOLAMIDE HYDROCHLORIDE Drug Profile


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

Dorzolamide Hydrochloride is a drug marketed by Akorn, Alembic Pharms Ltd, Am Regent, Bausch And Lomb, Fdc Ltd, Indoco, Micro Labs, Rubicon, Sandoz Inc, Teva Pharms, Zambon Spa, Aurobindo Pharma Ltd, Lannett Co Inc, Sandoz, and Somerset. and is included in twenty-six NDAs.

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

Drug patent expirations by year for DORZOLAMIDE HYDROCHLORIDE
Recent Clinical Trials for DORZOLAMIDE HYDROCHLORIDE

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

SponsorPhase
Guardion Health Sciences, Inc.Phase 4
University of the Incarnate WordPhase 4
Laboratorios Sophia S.A de C.V.Phase 1

See all DORZOLAMIDE HYDROCHLORIDE clinical trials

Pharmacology for DORZOLAMIDE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
TRUSOPT SOLUTION/DROPS;OPHTHALMIC dorzolamide hydrochloride 020408 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
Akorn DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 077846-001 Oct 28, 2008 AT RX No No   Get Started Free   Get Started Free   Get Started Free
Indoco DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 202054-001 Sep 3, 2014 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Somerset DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 207523-001 Jun 25, 2019 AT RX No No   Get Started Free   Get Started Free   Get Started Free
Micro Labs DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 204778-001 Nov 8, 2019 AT RX No No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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