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Last Updated: August 5, 2020

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TIMOPTIC Drug Profile

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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.

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Drug patent expirations by year for TIMOPTIC
Drug Prices for TIMOPTIC

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Recent Clinical Trials for TIMOPTIC

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SponsorPhase
University of California, San DiegoN/A
Bausch & Lomb IncorporatedN/A
Inotek Pharmaceuticals CorporationPhase 3

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Pharmacology for TIMOPTIC

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

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

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