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Last Updated: June 29, 2022

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 Thea Pharma, Akorn, Alembic Pharms Ltd, Bausch And Lomb, Eugia Pharma, Fdc Ltd, Indoco, Lannett Co Inc, Micro Labs, Rubicon, Sandoz, Sandoz Inc, Somerset, Teva Pharms, and Zambon Spa, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

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
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 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
Zambon Spa DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091180-001 Dec 4, 2013 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Micro Labs DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 215936-001 Jan 25, 2022 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lannett Co Inc DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 201998-001 Dec 17, 2014 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Thea Pharma COSOPT PF dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 202667-001 Feb 1, 2012 AT RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eugia Pharma DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 207629-001 May 14, 2021 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 090604-001 Nov 18, 2009 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 077847-001 Oct 28, 2008 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Thea Pharma COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 See Plans and Pricing See Plans and Pricing
Thea Pharma COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 See Plans and Pricing See Plans and Pricing
Thea Pharma COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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