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Last Updated: May 14, 2021

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TORADOL Drug Profile

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When do Toradol patents expire, and what generic alternatives are available?

Toradol is a drug marketed by Roche Palo and is included in two NDAs.

The generic ingredient in TORADOL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Drug patent expirations by year for TORADOL
Recent Clinical Trials for TORADOL

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SponsorPhase
Carilion ClinicPhase 3
Alberta Children's HospitalPhase 2
Hospital Authority, Hong KongPhase 3

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Paragraph IV (Patent) Challenges for TORADOL
Tradename Dosage Ingredient NDA Submissiondate
TORADOL INJECTABLE;INJECTION ketorolac tromethamine 019698
TORADOL TABLET;ORAL ketorolac tromethamine 019645

US Patents and Regulatory Information for TORADOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo TORADOL ketorolac tromethamine INJECTABLE;INJECTION 019698-001 Nov 30, 1989 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Roche Palo TORADOL ketorolac tromethamine INJECTABLE;INJECTION 019698-002 Nov 30, 1989 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Roche Palo TORADOL ketorolac tromethamine TABLET;ORAL 019645-001 Dec 20, 1991 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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 TORADOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 2015/071 Ireland   Get Started for $10 PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 CA 2015 00072 Denmark   Get Started for $10 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 C 2015 055 Romania   Get Started for $10 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 15C0090 France   Get Started for $10 PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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