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Last Updated: January 25, 2020

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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 Oak Pharms Inc, Akorn Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Fdc Ltd, Hi Tech Pharma, Lannett Co Inc, Rubicon, Sandoz, Sandoz Inc, Somerset, 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

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

Recent Litigation for DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Identify potential future generic entrants

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
Bausch And Lomb DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 090037-001 Jul 14, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 090604-001 Nov 18, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Oak Pharms Inc COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 AT RX Yes Yes   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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Serving leading biopharmaceutical companies globally:

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