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Last Updated: March 29, 2024

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 freedom to operate?

Ketorolac tromethamine; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Lupin Ltd and Rayner Surgical, 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 eighty-five patent family members in thirty-nine countries.

Two suppliers are 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 Strength NDA ANDAs Submitted Submissiondate
OMIDRIA Injection ketorolac tromethamine; phenylephrine hydrochloride 1%/0.3% 205388 1 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
Lupin Ltd KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 210183-001 Jul 1, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ketorolac tromethamine; phenylephrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 ⤷  Try a Trial ⤷  Try a Trial
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 ⤷  Try a Trial ⤷  Try a Trial
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 ⤷  Try a Trial ⤷  Try a Trial
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ketorolac tromethamine; phenylephrine hydrochloride

Country Patent Number Title Estimated Expiration
China 1684701 Ophthalmologic irrigation solutions and method ⤷  Try a Trial
Luxembourg 92923 ⤷  Try a Trial
Costa Rica 20150233 SOLUCIONES INYECTABLES ESTABLES EXENTAS DE CONSERVANTES DE COMPUESTOS ANTIMIDRIÁSICOS Y ANTI-INFLAMATORIOS ⤷  Try a Trial
New Zealand 628398 Stable preservative-free mydriatic and anti-inflammatory solutions for injection ⤷  Try a Trial
Japan 2013216705 OPHTHALMOLOGIC IRRIGATION SOLUTION AND METHOD ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ketorolac tromethamine; phenylephrine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 CR 2015 00072 Denmark ⤷  Try a Trial PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313 1590074-9 Sweden ⤷  Try a Trial PRODUCT NAME: EN KOMBINATION INNEFATTANDE FENYLEFRIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV OCH KETOROLAK ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/15/1018 20150730
1534313 CA 2015 00072 Denmark ⤷  Try a 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
1534313 264 5031-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313 122015000111 Germany ⤷  Try a 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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