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Last Updated: August 15, 2022

COSOPT Drug Patent Profile


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

Cosopt is a drug marketed by Thea Pharma 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 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 COSOPT

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

International Patents for COSOPT

See the table below for patents covering COSOPT around the world.

Country Patent Number Title Estimated Expiration
Luxembourg 90506 See Plans and Pricing
Lithuania 3368 OPHTALMIC COMBINATIONS OF CARBONIC ANHYDRASE INHIBITORS AND B-BLOCKERS See Plans and Pricing
South Africa 8804537 See Plans and Pricing
Austria 86998 See Plans and Pricing
Austria 182787 See Plans and Pricing
Czech Republic 9302098 See Plans and Pricing
Luxembourg 85264 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COSOPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0509752 2000C/001 Belgium See Plans and Pricing 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
0509752 CA 2000 00002 Denmark See Plans and Pricing
0509752 C990041 Netherlands See Plans and Pricing 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 49/1999 Austria See Plans and Pricing PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
0296879 96C0003 Belgium See Plans and Pricing PRODUCT NAME: HYDROCHLORIDUM, EQ. DORZOLAMIDUM; NAT. REGISTRATION NO/DATE: 922 IS 168 F13 19951019; FIRST REGISTRATION: SE 12208 19941219
0509752 SPC/GB99/043 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.