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Last Updated: March 26, 2023

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-one 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.

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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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516-001 Jun 4, 2004 See Plans and Pricing See Plans and Pricing
>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
0227494 95C0013 Belgium See Plans and Pricing PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
0509752 2000C/001 Belgium See Plans and Pricing 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 49/1999 Austria See Plans and Pricing 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

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Serving leading biopharmaceutical companies globally:

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