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Last Updated: June 21, 2024

DORZOLAMIDE HYDROCHLORIDE Drug Patent Profile


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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. Seventeen 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
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
Zambon Spa DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091180-001 Dec 4, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 078749-001 Nov 6, 2008 AT1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 090604-001 Nov 18, 2009 AT1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 212639-001 Aug 9, 2019 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 207629-001 May 14, 2021 AT1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ingenus Pharms Llc DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 217260-001 May 1, 2023 AT2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Indoco DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 202053-001 Sep 11, 2014 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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