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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Covington
Fish and Richardson
Cipla
Argus Health
Johnson and Johnson
Express Scripts
Julphar
Boehringer Ingelheim

Generated: September 26, 2018

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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 ketorolac tromethamine; phenylephrine hydrochloride freedom to operate?

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

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

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

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Supplementary Protection Certificates for ketorolac tromethamine; phenylephrine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000111 Germany ➤ Try a Free Trial PRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728
0784 Netherlands ➤ Try a Free Trial PRODUCT NAME: EEN OCULAIRE OPLOSSING WELKE FENYLEFRINE BEVAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ALSMEDE KETOROLAC, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
2015 00072 Denmark ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Covington
Fish and Richardson
Cipla
Argus Health
Johnson and Johnson
Express Scripts
Julphar
Boehringer Ingelheim

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