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Last Updated: March 28, 2024

Dorzolamide hydrochloride; timolol maleate - Generic Drug Details


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What are the generic sources for dorzolamide hydrochloride; timolol maleate and what is the scope of freedom to operate?

Dorzolamide hydrochloride; timolol maleate is the generic ingredient in three branded drugs marketed by Thea Pharma, Alembic, Bausch And Lomb, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Ingenus Pharms Llc, Micro Labs, Rubicon, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for dorzolamide hydrochloride; timolol maleate
Recent Clinical Trials for dorzolamide hydrochloride; timolol maleate

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

SponsorPhase
University of FloridaPhase 1
AllerganPhase 3
AllerganPhase 4

See all dorzolamide hydrochloride; timolol maleate clinical trials

Pharmacology for dorzolamide hydrochloride; timolol maleate
Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COSOPT Ophthalmic Solution dorzolamide hydrochloride; timolol maleate 2%/0.5% 020869 1 2005-10-11

US Patents and Regulatory Information for dorzolamide hydrochloride; timolol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 078704-001 Sep 28, 2009 DISCN No 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
Zambon Spa DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091180-001 Dec 4, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 213099-001 May 4, 2021 AT1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma COSOPT PF dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 202667-001 Feb 1, 2012 AT2 RX Yes Yes ⤷  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; timolol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Thea Pharma COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Try a Trial ⤷  Try a Trial
Thea Pharma COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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