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Ketorolac tromethamine - Generic Drug Details

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What are the generic sources for ketorolac tromethamine and what is the scope of patent protection?

Ketorolac tromethamine is the generic ingredient in nine branded drugs marketed by Amphastar Pharm, Apotex Inc, Apothecon, Atlantide, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Nephron, Sagent Pharms Inc, Sandoz Inc, Sun Pharm, West-ward Pharms Int, Wockhardt, Roche Palo, Allergan, Akorn, Micro Labs Ltd India, Zyla, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, Lupin Ltd, and Omeros, and is included in fifty-three NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine has sixty-seven patent family members in twenty-five countries.

There are eighteen drug master file entries for ketorolac tromethamine. Forty-six suppliers are listed for this compound.

Summary for ketorolac tromethamine

International Patents:	67
US Patents:	19
Tradenames:	9
Applicants:	30
NDAs:	53
Drug Master File Entries:	18
Suppliers / Packagers:	46
Bulk Api Vendors:	78
Clinical Trials:	72
Patent Applications:	6,651
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ketorolac tromethamine
Drug Sales Revenues:	Drug sales revenues for ketorolac tromethamine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ketorolac tromethamine
DailyMed Link:	ketorolac tromethamine at DailyMed

See drug prices for ketorolac tromethamine

See drug sales revenues for ketorolac tromethamine

Recent Clinical Trials for ketorolac tromethamine

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

Sponsor	Phase
EMS	Phase 2
Oman Medical Speciality Board	Phase 2/Phase 3
University of Louisville	Phase 4

See all ketorolac tromethamine clinical trials

Pharmacology for ketorolac tromethamine

Drug Class	Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for ketorolac tromethamine

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for KETOROLAC TROMETHAMINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
SPRIX	SPRAY, METERED;NASAL	ketorolac tromethamine	022382	2012-03-12
ACUVAIL	SOLUTION/DROPS;OPHTHALMIC	ketorolac tromethamine	022427	2011-08-24
ACULAR LS	SOLUTION/DROPS;OPHTHALMIC	ketorolac tromethamine	021528	2005-01-28
TORADOL	INJECTABLE;INJECTION	ketorolac tromethamine	019698
TORADOL	TABLET;ORAL	ketorolac tromethamine	019645

US Patents and Regulatory Information for ketorolac tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	074801-002	Jun 5, 1997		DISCN	No	No
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes					Y
West-ward Pharms Int	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075772-002	Jul 21, 2004	AP	RX	No	No

Expired US Patents for ketorolac tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997
Allergan	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Roche Palo	TORADOL	ketorolac tromethamine	TABLET;ORAL	019645-001	Dec 20, 1991

International Patents for ketorolac tromethamine

Country	Patent Number	Estimated Expiration
Slovenia	2555770
Poland	1654002
South Korea	20120058588

Supplementary Protection Certificates for ketorolac tromethamine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
1534313	300784	Netherlands		PRODUCT NAME: EEN OCULAIRE OPLOSSING WELKE FENYLEFRINE BEVAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ALSMEDE KETOROLAC, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730