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Last Updated: January 18, 2020

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OMIDRIA Drug Profile

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Which patents cover Omidria, and what generic alternatives are available?

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

This drug has sixty-four patent family members in thirty-three 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.

US ANDA Litigation and Generic Entry Outlook for Omidria

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Omidria was eligible for patent challenges on December 31st, 1968.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Drug patent expirations by year for OMIDRIA
Drug Prices for OMIDRIA

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Recent Clinical Trials for OMIDRIA

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

SponsorPhase
Wake Forest University Health SciencesPhase 4
Omeros CorporationPhase 4
Milton S. Hershey Medical CenterPhase 4

See all OMIDRIA clinical trials

Recent Litigation for OMIDRIA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Omeros Corporation v. Lupin Ltd.2017-06-22
OMEROS CORPORATION v. LUPIN LTD2017-06-22
Omeros Corporation v. Sandoz Inc.2017-06-21

See all OMIDRIA litigation

Synonyms for OMIDRIA
Ketorolac / phenylephrine
Ketorolac mixture with phenylephrine
OMS 302
OMS302
Phenylephrine and ketorolac injection
S900006490
Paragraph IV (Patent) Challenges for OMIDRIA
Tradename Dosage Ingredient NDA Submissiondate
OMIDRIA SOLUTION;IRRIGATION ketorolac tromethamine; phenylephrine hydrochloride 205388 2015-05-29

US Patents and Regulatory Information for OMIDRIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for OMIDRIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 15C0090 France   Start 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
1534313 C20150054 00179 Estonia   Start Trial PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
1534313 CA 2015 00072 Denmark   Start Trial PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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