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OMIDRIA Drug Profile

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Omidria is a drug marketed by Omeros and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty-one patent family members in twenty-six 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.

Summary for Tradename: OMIDRIA

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYes8,173,707► subscribe ► subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYes► subscribe► subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYes9,486,406► subscribeY ► subscribe
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Paragraph IV activity for: OMIDRIA

Drugname Dosage Strength RLD Submissiondate
phenylephrine and ketorolacInjection1%/0.3%Omidria5/29/2015

International Patent Family for Tradename: OMIDRIA

Country Document Number Estimated Expiration
New Zealand628398► subscribe
Canada2887772► subscribe
Eurasian Patent Organization201590807► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OMIDRIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
923Luxembourg► subscribePRODUCT 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
0150054 00179Estonia► subscribePRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
C0090France► subscribePRODUCT 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
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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 verifification 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.

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