Ketorolac tromethamine - Generic Drug Details

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, Baxter Hlthcare Corp, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Sagent Pharms Inc, Sandoz Inc, Steriscience, Sun Pharm, Wockhardt, Roche Palo, Allergan, Akorn, Micro Labs Ltd India, Zyla, Cycle Pharms Ltd, Hetero Labs Ltd Iii, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Lupin Ltd, and Rayner Surgical, and is included in fifty-six 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-eight patent family members in twenty-five countries.

There are sixteen drug master file entries for ketorolac tromethamine. Fifty-two suppliers are listed for this compound.

Summary for ketorolac tromethamine

International Patents:	68
US Patents:	19
Tradenames:	9
Applicants:	33
NDAs:	56
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	103
Patent Applications:	7,057
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
What excipients (inactive ingredients) are in ketorolac tromethamine?	ketorolac tromethamine excipients list
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
Andrew Hendifar, MD	Early Phase 1
NEMA Research, Inc.	Phase 3
Nuance Pharma (shanghai) Co., Ltd	Phase 1

See all ketorolac tromethamine clinical trials

Pharmacology for ketorolac tromethamine

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
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	Strength	NDA	ANDAs Submitted	Submissiondate
SPRIX	Nasal Spray	ketorolac tromethamine	15.75 mg/spray	022382	1	2012-03-12
ACUVAIL	Opthalmic Solution	ketorolac tromethamine	0.45%	022427	1	2011-08-24
ACULAR LS	Ophthalmic Solution	ketorolac tromethamine	0.4%	021528	1	2005-01-28

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
Eugia Pharma	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	212939-001	Oct 20, 2020		DISCN	No	No
Sun Pharm	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	078737-001	Oct 6, 2008	AP	RX	No	No
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes			Y
Mylan	KETOROLAC TROMETHAMINE	ketorolac tromethamine	TABLET;ORAL	074761-001	May 16, 1997	AB	RX	No	No

Expired US Patents for ketorolac tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010
Allergan	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003

International Patents for ketorolac tromethamine

Country	Patent Number	Title	Estimated Expiration
Canada	2796071	COMPOSITIONS DE KETOROLAC POUR LA CICATRISATION DE LESIONS CORNEENNES (KETOROLAC COMPOSITIONS FOR CORNEAL WOUND HEALING)
South Korea	20100130989	KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN
Slovenia	2555770
European Patent Office	2446878	Compositions de kétorolac trométhamine pour traiter ou prévenir la douleur oculaire (Ketorolac tromethamine compositions for treating or preventing ocular pain)

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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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