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Last Updated: March 4, 2024

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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-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.

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
European Society of Cataract and Refractive SurgeonsPhase 3
Luigi RondasPhase 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: ⤷  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 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 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 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
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
New Zealand 628398 Stable preservative-free mydriatic and anti-inflammatory solutions for injection ⤷  Try a Trial
Mexico 2015005089 SOLUCIONES MIDRIATICAS Y ANTIINFLAMATORIAS INYECTABLES, ESTABLES Y LIBRES DE CONSERVANTES. (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION.) ⤷  Try a Trial
Australia 2013201465 Stable preservative-free mydriatic and anti-inflammatory solutions for injection ⤷  Try a Trial
Hong Kong 1081455 OPHTHALMOLOGIC IRRIGATION SOLUTIONS AND METHOD ⤷  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 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 300784 Netherlands ⤷  Try a Trial PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313 122015000111 Germany ⤷  Try a Trial PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.