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Last Updated: November 30, 2020

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KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for ketorolac tromethamine; phenylephrine hydrochloride and what is the scope of patent protection?

Ketorolac tromethamine; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Lupin Ltd and Omeros, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine; phenylephrine hydrochloride has sixty-seven patent family members in thirty-three countries.

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

Summary for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Pharmacology for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
OMIDRIA SOLUTION;IRRIGATION ketorolac tromethamine; phenylephrine hydrochloride 205388 2015-05-29

US Patents and Regulatory Information for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

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
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 KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 C 2015 055 Romania   Start Trial PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728
1534313 C20150054 00179 Estonia   Start Trial PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
1534313 76/2015 Austria   Start 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 122015000111 Germany   Start Trial PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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