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Last Updated: January 28, 2021

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ISTALOL Drug 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. Seventeen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Istalol

A generic version of ISTALOL was approved as timolol maleate by MYLAN on June 8th, 1990.

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Drug patent expirations by year for ISTALOL
Drug Prices for ISTALOL

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Drug Sales Revenue Trends for ISTALOL

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Recent Clinical Trials for ISTALOL

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SponsorPhase
Bp Consulting, IncPhase 4

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Pharmacology for ISTALOL
Paragraph IV (Patent) Challenges for ISTALOL
Tradename Dosage Ingredient NDA Submissiondate
ISTALOL SOLUTION/DROPS;OPHTHALMIC timolol maleate 021516 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   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 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   Start Trial   Start Trial
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516-001 Jun 4, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ISTALOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 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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