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Last Updated: August 4, 2021

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COSOPT Drug Patent Profile


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Which patents cover Cosopt, and what generic alternatives are available?

Cosopt is a drug marketed by Akorn and is included in two NDAs.

The generic ingredient in COSOPT is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Paragraph IV (Patent) Challenges for COSOPT
Tradename Dosage Ingredient NDA Submissiondate
COSOPT SOLUTION/DROPS;OPHTHALMIC dorzolamide hydrochloride; timolol maleate 020869 2005-10-11

US Patents and Regulatory Information for COSOPT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 AT RX Yes Yes ⤷  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 COSOPT

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

Supplementary Protection Certificates for COSOPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0509752 SPC/GB99/043 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
0509752 CA 2000 00002 Denmark ⤷  Free Forever Trial
0509752 C990041 Netherlands ⤷  Free Forever Trial PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
0509752 2000C/001 Belgium ⤷  Free Forever Trial PRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Boehringer Ingelheim
McKinsey
Moodys
Express Scripts

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