TORADOL Drug Patent 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. Sixty-eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Toradol
A generic version of TORADOL was approved as ketorolac tromethamine by MYLAN on May 16th, 1997.
Summary for TORADOL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 134 |
Patent Applications: | 4,893 |
Formulation / Manufacturing: | see details |
DailyMed Link: | TORADOL at DailyMed |
Recent Clinical Trials for TORADOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Arkansas Children's Hospital Research Institute | Phase 4 |
University of Miami | Phase 2 |
McMaster University | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for TORADOL
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roche Palo | TORADOL | ketorolac tromethamine | INJECTABLE;INJECTION | 019698-002 | Nov 30, 1989 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roche Palo | TORADOL | ketorolac tromethamine | TABLET;ORAL | 019645-001 | Dec 20, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 TORADOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche Palo | TORADOL | ketorolac tromethamine | TABLET;ORAL | 019645-001 | Dec 20, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TORADOL
See the table below for patents covering TORADOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 479980 | ⤷ Try a Trial | |
Japan | S6254792 | ⤷ Try a Trial | |
Austria | 364844 | ⤷ Try a Trial | |
South Africa | 7704238 | ⤷ Try a Trial | |
Denmark | 151335 | ⤷ Try a Trial | |
United Kingdom | 1554075 | ⤷ Try a Trial | |
Denmark | 151337 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TORADOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534313 | 15C0090 | France | ⤷ Try a Trial | 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 |
1534313 | C 2015 055 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA |
1534313 | 92923 | Luxembourg | ⤷ Try a Trial | 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 |
1534313 | 122015000111 | Germany | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
1534313 | 300784 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
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 | 2015/071 | Ireland | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |