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:	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

See all TORADOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TORADOL

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Netherlands	7707651
Hungary	174224	SPOSOB POLUCHENIJA PROIZVODNYKH 5-BENZOIL-1,2-DIGIDRO-3H-PIRROLO/1,2-A/PIRROLIL-1-KARBONOVOJJ KISLOTY (PROCESS FOR PREPARING 5-BENZOYL-1,2-DIHYDRO-3H-PYRROLO/1,2-A/PYRROLE-1-CARBOXYLIC ACID DERIVATIVES)
New Zealand	184610	5-BENZOYL-1,2-DIHYDRO-3H-PYRROLO(1,2-A)PYRROLE-1-CARBOXYLIC ACIDS AND PHARMACEUTICAL COMPOSITIONS
Ireland	45253	1,2-DIHYDRO-3H-PYRROLO (1,2-A)PYRROLE-1-CARBOXYLIC ACID DERIVATIES AND PROCESS FOR THE PRODUCTION THEREOF
U.S.S.R.	1151211	METHOD OF OBTAINING 5-AROYL-1,2-DIHYDRO-3H-PYRROLE /1,2-A/-PYRROLE-1-CARBOXYLIC ACID

Supplementary Protection Certificates for TORADOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	76/2015	Austria		PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	92923	Luxembourg		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