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Ketorolac tromethamine; phenylephrine hydrochloride - Generic Drug Details

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Ketorolac tromethamine; phenylephrine hydrochloride is the generic ingredient in one branded drug marketed by Omeros and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are eighteen drug master file entries for ketorolac tromethamine; phenylephrine hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: ketorolac tromethamine; phenylephrine hydrochloride

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list18
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ketorolac tromethamine; phenylephrine hydrochloride

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, 2014RXYes9,066,856► subscribeY ► subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYes9,278,101► subscribe ► subscribe
Omeros
OMIDRIA
ketorolac tromethamine; phenylephrine hydrochloride
SOLUTION;IRRIGATION205388-001May 30, 2014RXYes9,486,406► subscribeY ► subscribe
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International Patent Family for Ingredient: ketorolac tromethamine; phenylephrine hydrochloride

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: KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

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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