COSOPT Drug Patent Profile
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When do Cosopt patents expire, and when can generic versions of Cosopt launch?
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. Seventeen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cosopt
A generic version of COSOPT was approved as dorzolamide hydrochloride; timolol maleate by HIKMA on October 28th, 2008.
Summary for COSOPT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 35 |
Patent Applications: | 385 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for COSOPT |
Drug Sales Revenues: | Drug sales revenues for COSOPT |
What excipients (inactive ingredients) are in COSOPT? | COSOPT excipients list |
DailyMed Link: | COSOPT at DailyMed |
Recent Clinical Trials for COSOPT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Wills Eye | Phase 2/Phase 3 |
Mid Atlantic Retina | Phase 2/Phase 3 |
J. Arch McNamara Research Fund | Phase 2 |
Pharmacology for COSOPT
Drug Class | Carbonic Anhydrase Inhibitor beta-Adrenergic Blocker |
Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for COSOPT
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 | AT1 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Thea Pharma | COSOPT PF | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 202667-001 | Feb 1, 2012 | AT2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Thea Pharma | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Thea Pharma | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Thea Pharma | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Thea Pharma | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
United Kingdom | 2155331 | COMPOSITION FOR REDUCING INTRAOCULAR PRESSURE | ⤷ Try a Trial |
Austria | 86998 | ⤷ Try a Trial | |
Ireland | 811235 | ⤷ Try a Trial | |
Canada | 2065965 | COMPOSITIONS OPHTALMIQUES COMPRENANT UN INHIBITEUR DE L'ANHYDRASE CARBONIQUE ET UN ANTAGONISTE DES RECEPTEURS BETA-ADRENERGIQUES (OPHTHALMIC COMPOSITIONS COMPRISING COMBINATIONS OF A CARBONIC ANHYDRASE INHIBITOR AND A BETA-ADRENERGIC ANTAGONIST) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COSOPT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0296879 | 96C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: HYDROCHLORIDUM, EQ. DORZOLAMIDUM; NAT. REGISTRATION NO/DATE: 922 IS 168 F13 19951019; FIRST REGISTRATION: SE 12208 19941219 |
0509752 | 49/1999 | Austria | ⤷ Try a Trial | 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 |
0509752 | SPC/GB99/043 | United Kingdom | ⤷ Try a 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 | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |