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 |
| Hamilton Health Sciences Corporation | 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 |
|---|---|---|---|
| Canada | 1102809 | PROCEDE D'OBTENTION DE DERIVES D'ACIDES 5-AROYL-1,2- DIHYDRO-3H-PYRROLO [1,2-A]-PYRROLE-1- CARBOXYLIQUES (5-AROYL-1,2-DIHYDRO-3H-PYRROLO (1,2-A)-PYRROLE-1- CARBOXYLIC ACID DERIVATIVES AND PROCESS FOR THE PRODUCTION THEREOF) | ⤷ Try a Trial |
| Japan | S61191686 | 1,2-DIHYDRO-3H-PYRROLO(1,2-A)PYRROLE-1-CARBOXYLIC ACID COMPOUND AND MANUFACTURE | ⤷ Try a Trial |
| Finland | 63406 | ⤷ Try a Trial | |
| Malaysia | 8100357 | 1,2-DIHYDRO-3H-PYROLO[1,2-A]PYRROLE-1-CARBOXYLIC ACID DERIVATIVES AND PROCESS FOR THE PRODUCTION THEREOF | ⤷ 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 | 122015000111 | Germany | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
ISSN: 2162-2639
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