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Last Updated: June 18, 2021

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Dorzolamide hydrochloride; timolol maleate - Generic Drug Details

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What are the generic drug sources for dorzolamide hydrochloride; timolol maleate and what is the scope of patent protection?

Dorzolamide hydrochloride; timolol maleate is the generic ingredient in three branded drugs marketed by Akorn, Aurobindo Pharma Ltd, Bausch And Lomb, Fdc Ltd, Indoco, Lannett Co Inc, Micro Labs, Rubicon, Sandoz, Sandoz Inc, Somerset, Teva Pharms, and Zambon Spa, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for dorzolamide hydrochloride; timolol maleate. Thirteen 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 NDA Submissiondate
COSOPT SOLUTION/DROPS;OPHTHALMIC dorzolamide hydrochloride; timolol maleate 020869 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
Fdc Ltd DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 205295-001 Jun 13, 2019 AT RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Akorn DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 077847-001 Oct 28, 2008 AT RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 AT RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Zambon Spa DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091180-001 Dec 4, 2013 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Bausch And Lomb DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 090037-001 Jul 14, 2009 AT RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998   Try Before You Buy   Try Before You Buy
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998   Try Before You Buy   Try Before You Buy
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998   Try Before You Buy   Try Before You Buy
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
McKesson
Dow
AstraZeneca
Express Scripts

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