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Last Updated: January 31, 2023

OMIDRIA Drug Patent Profile


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Which patents cover Omidria, and when can generic versions of Omidria launch?

Omidria is a drug marketed by Rayner Surgical and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-one patent family members in thirty-nine countries.

The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.

Drug patent expirations by year for OMIDRIA
Drug Prices for OMIDRIA

See drug prices for OMIDRIA

Recent Clinical Trials for OMIDRIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Luigi RondasPhase 3
European Society of Cataract and Refractive SurgeonsPhase 3
University of FloridaPhase 4

See all OMIDRIA clinical trials

Paragraph IV (Patent) Challenges for OMIDRIA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OMIDRIA Injection ketorolac tromethamine; phenylephrine hydrochloride 1%/0.3% 205388 1 2015-05-29

US Patents and Regulatory Information for OMIDRIA

OMIDRIA is protected by seven US patents.

Patents protecting OMIDRIA

Ophthalmologic irrigation solutions and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ophthalmologic irrigation solutions and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ophthalmologic irrigation solutions and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ophthalmologic irrigation solutions and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: See Plans and Pricing
Patent Expiration: 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
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

International Patents for OMIDRIA

See the table below for patents covering OMIDRIA around the world.

Country Patent Number Title Estimated Expiration
Chile 2015001078 Una formulacion farmaceutica liquida y esteril que comprende fenilefrina, ketorolaco y un sistema tamponante en un vehiculo acuoso, en donde la formulacion se encuentra libre de conservantes y de antioxidantes y es estable durante al menos seis meses almacenada a una temperatura de 5°c a 25°c. See Plans and Pricing
Georgia, Republic of P20186891 STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION See Plans and Pricing
Canada 2887772 SOLUTIONS MYDRIATIQUES ET ANTI-INFLAMMATOIRES STABLES SANS AGENTS DE CONSERVATION DESTINEES A ETRE INJECTEES (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) See Plans and Pricing
Canada 2866848 SOLUTIONS ET PROCEDE D'IRRIGATION OPHTALMOLOGIQUE (OPHTHALMOLOGIC IRRIGATION SOLUTIONS AND METHOD) See Plans and Pricing
Japan 2016014055 眼科学的洗浄溶液および眼科学的洗浄方法 (OPHTHALMOLOGIC IRRIGATION SOLUTIONS AND OPHTHALMOLOGIC IRRIGATION METHOD) See Plans and Pricing
Hungary S1500069 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OMIDRIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 2015/071 Ireland See Plans and Pricing PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 122015000111 Germany See Plans and Pricing PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 92923 Luxembourg See Plans and Pricing PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313 1590074-9 Sweden See Plans and Pricing PRODUCT NAME: EN KOMBINATION INNEFATTANDE FENYLEFRIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV OCH KETOROLAK ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/15/1018 20150730
1534313 C20150054 00179 Estonia See Plans and Pricing PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
1534313 264 5031-2015 Slovakia See Plans and Pricing PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
AstraZeneca
Dow
Harvard Business School
McKinsey

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