omidria Drug Patent Profile
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When do Omidria patents expire, and what generic alternatives are available?
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: | 19 |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Japan | 2016196511 | 安定で保存剤非含有の散瞳および抗炎症注射用液剤 (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
Serbia | 62188 | STABILNI MIDRIJATSKI I ANTI-INFLAMATORNI RASTVORI BEZ KONZERVANSA ZA UBRIZGAVANJE (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
Eurasian Patent Organization | 033811 | СТАБИЛЬНЫЕ БЕСКОНСЕРВАНТНЫЕ МИДРИАТИЧЕСКИЕ И ПРОТИВОВОСПАЛИТЕЛЬНЫЕ РАСТВОРЫ ДЛЯ ИНЪЕКЦИЙ (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for omidria
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534313 | 1590074-9 | Sweden | ⤷ Try a Trial | 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 | 76/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730 |
1534313 | 15C0090 | France | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |