ISTALOL Drug Patent Profile
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When do Istalol patents expire, and when can generic versions of Istalol launch?
Istalol is a drug marketed by Bausch And Lomb and is included in one NDA.
The generic ingredient in ISTALOL is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Istalol
A generic version of ISTALOL was approved as timolol maleate by MYLAN on June 8th, 1990.
Summary for ISTALOL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 1 |
Patent Applications: | 4,690 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ISTALOL |
What excipients (inactive ingredients) are in ISTALOL? | ISTALOL excipients list |
DailyMed Link: | ISTALOL at DailyMed |
Recent Clinical Trials for ISTALOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bp Consulting, Inc | Phase 4 |
Pharmacology for ISTALOL
Drug Class | beta-Adrenergic Blocker |
Mechanism of Action | Adrenergic beta-Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ISTALOL
Paragraph IV (Patent) Challenges for ISTALOL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ISTALOL | Ophthalmic Solution | timolol maleate | 0.5% | 021516 | 1 | 2012-10-19 |
US Patents and Regulatory Information for ISTALOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch And Lomb | ISTALOL | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021516-001 | Jun 4, 2004 | 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 ISTALOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch And Lomb | ISTALOL | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021516-001 | Jun 4, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch And Lomb | ISTALOL | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021516-001 | Jun 4, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ISTALOL
See the table below for patents covering ISTALOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4377052 | ⤷ Try a Trial | |
Canada | 2307303 | COLLYRES A LIBERATION PROLONGEE (PROLONGED-ACTION EYE DROP) | ⤷ Try a Trial |
Spain | 2297894 | ⤷ Try a Trial | |
China | 1278162 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ISTALOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0227494 | 95C0013 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910 |
0509752 | 2000C/001 | Belgium | ⤷ Try a 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 |
0509752 | C990041 | Netherlands | ⤷ Try a 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |