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Serving hundreds of leading biopharmaceutical companies globally:

Merck
UBS
Cerilliant
Cipla
Fish and Richardson
Fuji
Federal Trade Commission
US Army
Teva

Generated: May 28, 2018

DrugPatentWatch Database Preview

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 patent protection?

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.

Ketorolac tromethamine; phenylephrine hydrochloride has fifty-seven patent family members in thirty-one countries.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Non-Orange Book US Patents for ketorolac tromethamine; phenylephrine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,585,895 Ophthalmologic irrigation solutions and method ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ketorolac tromethamine; phenylephrine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000111 Germany ➤ Sign Up 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
4 5031-2015 Slovakia ➤ Sign Up PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730
923 Luxembourg ➤ Sign Up PRODUCT 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
/2015 Austria ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Express Scripts
Boehringer Ingelheim
Cerilliant
Baxter
Fuji
Chinese Patent Office
US Army

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.