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Last Updated: November 16, 2019

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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 Oak Pharms Inc, Akorn Inc, Anda Repository, Aurobindo Pharma Ltd, Bausch And Lomb, Fdc Ltd, Hi Tech Pharma, Lannett Co Inc, Rubicon, Sandoz, Sandoz Inc, Teva Pharms, Watson Labs Inc, and Zambon Spa, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for dorzolamide hydrochloride; timolol maleate. Eleven suppliers are listed for this compound.

Recent Clinical Trials for dorzolamide hydrochloride; timolol maleate

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SponsorPhase
University of FloridaPhase 1
AllerganPhase 3
AllerganPhase 4

See all dorzolamide hydrochloride; timolol maleate clinical trials

Recent Litigation for dorzolamide hydrochloride; timolol maleate

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District Court Litigation
Case NameDate
MERCK & CO., INC. v. APOTEX INC.2006-12-04
MERCK & CO., INC. v. HI-TECH PHARMACAL CO., INC.2006-01-18

See all dorzolamide hydrochloride; timolol maleate litigation

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
Teva Pharms DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 078704-001 Sep 28, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Hi Tech Pharma DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 077847-001 Oct 28, 2008 AT RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 203058-001 Sep 22, 2014 AT RX No No   Start Trial   Start Trial   Start 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
Oak Pharms Inc COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998   Start Trial   Start Trial
Oak Pharms Inc COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998   Start Trial   Start Trial
Oak Pharms Inc COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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