OMIDRIA Drug Patent Profile
✉ Email this page to a colleague
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-five 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. Two suppliers are 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: | 85 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 5 |
Patent Applications: | 5 |
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
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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 OMIDRIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OMIDRIA
See the table below for patents covering OMIDRIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20170128640 | 주사용의 안정한 보존제-비함유 산동 및 항-염증 용액 (- - STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLA mMATORY SOLUTIONS FOR INJECTION) | ⤷ Sign Up |
Spain | 2397574 | ⤷ Sign Up | |
Portugal | 2911511 | ⤷ Sign Up | |
Japan | 2010132696 | OPHTHALMOLOGIC IRRIGATION SOLUTION AND METHOD FOR OPHTHALMOLOGIC IRRIGATION | ⤷ Sign Up |
Japan | 2018009033 | 眼科学的洗浄溶液および眼科学的洗浄方法 (OPHTHALMOLOGIC IRRIGATION SOLUTION AND METHOD) | ⤷ Sign Up |
Australia | 2013202330 | Ophthalmologic irrigation solutions and method | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OMIDRIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534313 | C20150054 00179 | Estonia | ⤷ Sign Up | PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015 |
1534313 | 264 5031-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
1534313 | 15C0090 | France | ⤷ Sign Up | PRODUCT NAME: 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; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
1534313 | 92923 | Luxembourg | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | CR 2015 00072 | Denmark | ⤷ Sign Up | PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |