TORADOL Drug Patent Profile

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 16^th, 1997.

Summary for TORADOL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	137
Patent Applications:	4,893
DailyMed Link:	TORADOL at DailyMed

Recent Clinical Trials for TORADOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Henry Ford Health System	Phase 4
Damascus University	N/A
Arkansas Children's Hospital Research Institute	Phase 4

See all TORADOL clinical trials

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
Roche Palo	TORADOL	ketorolac tromethamine	INJECTABLE;INJECTION	019698-002	Nov 30, 1989		DISCN	Yes	No
Roche Palo	TORADOL	ketorolac tromethamine	TABLET;ORAL	019645-001	Dec 20, 1991		DISCN	Yes	No

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

International Patents for TORADOL

See the table below for patents covering TORADOL around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	470214
Norway	772494
Japan	S61191686	1,2-DIHYDRO-3H-PYRROLO(1,2-A)PYRROLE-1-CARBOXYLIC ACID COMPOUND AND MANUFACTURE
Slovenia	7711721	PROCESS FOR OBTAINING 5-AROYL-1,2 DEHYDRO-3H-PYRROLO (1,2-A)PYRROL-1-CARBOXYLIC DERIVATIVES
Croatia	P940490	5-AROYL-1,2-DIHYDRO-3H-PYRROLO(1,2-a)PYRROLE-1-CARBOXYLIC ACID DERIVATIVES AND PROCESS FOR THE PRODUCTION THEREOF
Netherlands	186318

Supplementary Protection Certificates for TORADOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	2015/071	Ireland		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		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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	C 2015 055	Romania		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	15C0090	France		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