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Last Updated: July 26, 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, Alembic Pharms Ltd, 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 eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for dorzolamide hydrochloride; timolol maleate. Fourteen 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
Meir Medical CenterN/A

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
Aurobindo Pharma Ltd DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 207630-001 Jul 24, 2018 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alembic Pharms Ltd DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 213099-001 May 4, 2021 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zambon Spa DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091180-001 Dec 4, 2013 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn COSOPT PF dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 202667-001 Feb 1, 2012 AT RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
Medtronic
Baxter

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