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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Omidria
A generic version of OMIDRIA was approved as ketorolac tromethamine; phenylephrine hydrochloride by LUPIN LTD on July 1st, 2019.
Summary for OMIDRIA
International Patents: | 81 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 5 |
Patent Applications: | 18 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OMIDRIA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OMIDRIA |
What excipients (inactive ingredients) are in OMIDRIA? | OMIDRIA excipients list |
DailyMed Link: | OMIDRIA at DailyMed |


Recent Clinical Trials for OMIDRIA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Luigi Rondas | Phase 3 |
European Society of Cataract and Refractive Surgeons | Phase 3 |
University of Florida | Phase 4 |
Pharmacology for OMIDRIA
Drug Class | Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for OMIDRIA
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 |