TRUSOPT Drug Patent Profile
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When do Trusopt patents expire, and what generic alternatives are available?
Trusopt is a drug marketed by Msd Sub Merck and is included in one NDA.
The generic ingredient in TRUSOPT is dorzolamide hydrochloride. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Trusopt
A generic version of TRUSOPT was approved as dorzolamide hydrochloride by RUBICON on October 28th, 2008.
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Summary for TRUSOPT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 12 |
| Patent Applications: | 4,627 |
| Drug Prices: | Drug price information for TRUSOPT |
| What excipients (inactive ingredients) are in TRUSOPT? | TRUSOPT excipients list |
| DailyMed Link: | TRUSOPT at DailyMed |
Recent Clinical Trials for TRUSOPT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 3 |
| National Eye Institute (NEI) | Phase 3 |
| National Eye Institute (NEI) | Phase 1/Phase 2 |
Paragraph IV (Patent) Challenges for TRUSOPT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TRUSOPT | Ophthalmic Solution | dorzolamide hydrochloride | 2% | 020408 | 1 | 2005-10-11 |
US Patents and Regulatory Information for TRUSOPT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | TRUSOPT | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020408-001 | Dec 9, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 TRUSOPT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | TRUSOPT | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020408-001 | Dec 9, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Msd Sub Merck | TRUSOPT | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020408-001 | Dec 9, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRUSOPT
See the table below for patents covering TRUSOPT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 1286294 | SULFAMIDES AROMATIQUES SUBSTITUES UTILISES CONTRE LE GLAUCOME (SUBSTITUTED AROMATIC SULFONAMIDES AS ANTIGLAUCOMA AGENTS) | ⤷ Sign Up |
| South Korea | 960004534 | ⤷ Sign Up | |
| Spain | 8704498 | ⤷ Sign Up | |
| South Africa | 8804537 | ⤷ Sign Up | |
| Ireland | 881933 | ⤷ Sign Up | |
| Germany | 19575017 | ⤷ Sign Up | |
| Spain | 2053738 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRUSOPT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0296879 | 96C0003 | Belgium | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | C990041 | Netherlands | ⤷ Sign Up | 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 |
| >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.
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