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Last Updated: June 19, 2021

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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 Akorn, Alembic Pharms Ltd, Am Regent, Bausch And Lomb, Fdc Ltd, Indoco, Micro Labs, Rubicon, Sandoz Inc, Teva Pharms, Zambon Spa, Merck, Aurobindo Pharma Ltd, Lannett Co Inc, Sandoz, and Somerset, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for dorzolamide hydrochloride. Ten 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
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 COSOPT PF dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 202667-001 Feb 1, 2012 AT RX Yes Yes   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
Akorn DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 077847-001 Oct 28, 2008 AT RX No No   Get Started Free   Get Started Free   Get Started Free
Rubicon DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 078201-001 Oct 28, 2008 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Fdc Ltd DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 205295-001 Jun 13, 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

Expired US Patents for dorzolamide hydrochloride

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

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