DrugPatentWatch Database Preview
TIMOPTIC Drug Profile
» See Plans and Pricing
Which patents cover Timoptic, and when can generic versions of Timoptic launch?
Timoptic is a drug marketed by Valeant Pharms Intl and Valeant Pharms Llc and is included in three NDAs.
The generic ingredient in TIMOPTIC is timolol maleate. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
US ANDA Litigation and Generic Entry Outlook for Timoptic
A generic version of TIMOPTIC was approved as timolol maleate by MYLAN on June 8th, 1990.
Summary for TIMOPTIC
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 23 |
| Clinical Trials: | 17 |
| Patent Applications: | 4,371 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TIMOPTIC |
| Drug Sales Revenues: | Drug sales revenues for TIMOPTIC |
| DailyMed Link: | TIMOPTIC at DailyMed |
Recent Clinical Trials for TIMOPTIC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Diego | N/A |
| Bausch & Lomb Incorporated | N/A |
| Inotek Pharmaceuticals Corporation | Phase 3 |
Pharmacology for TIMOPTIC
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
US Patents and Regulatory Information for TIMOPTIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valeant Pharms Intl | TIMOPTIC | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 018086-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Valeant Pharms Intl | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-002 | Nov 5, 1986 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Valeant Pharms Intl | TIMOPTIC | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 018086-002 | Approved Prior to Jan 1, 1982 | AT1 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Valeant Pharms Intl | TIMOPTIC IN OCUDOSE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 019463-001 | Nov 5, 1986 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Valeant Pharms Llc | TIMOPTIC-XE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020330-002 | Nov 4, 1993 | AB | 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 TIMOPTIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Pharms Intl | TIMOPTIC | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 018086-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Valeant Pharms Intl | TIMOPTIC | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 018086-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Valeant Pharms Intl | TIMOPTIC | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 018086-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Valeant Pharms Intl | TIMOPTIC | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 018086-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TIMOPTIC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 85165 | Start Trial |
| Canada | 985698 | Start Trial |
| Switzerland | 533080 | Start Trial |
| France | 2039306 | Start Trial |
| Cyprus | 1023 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TIMOPTIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0509752 | C990041 | Netherlands | Start 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 |
| 0227494 | 95C0013 | Belgium | Start Trial | PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910 |
| 0509752 | 49/1999 | Austria | Start 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 | Start 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 | 2000C/001 | Belgium | Start 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 |
