KETOROLAC TROMETHAMINE - Generic Drug Details

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

Ketorolac tromethamine is the generic ingredient in nine branded drugs marketed by Alembic, Amphastar Pharm, Apotex Inc, Apothecon, Aspiro, Baxter Hlthcare Corp, Bedford, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Sagent Pharms Inc, Sandoz, Steriscience Speclts, Sun Pharm, Wockhardt, Wockhardt Bio Ag, Roche Palo, Abbvie, Allergan, Chartwell Rx, Epic Pharma Llc, Micro Labs Ltd India, Zyla, Atnahs Pharma Us, Bionpharma, Hetero Labs Ltd Iii, Leading, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Zydus Lifesciences, Lupin Ltd, and Rayner Surgical, and is included in sixty-four 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. Sixty-nine suppliers are listed for this compound.

Summary for KETOROLAC TROMETHAMINE

International Patents:	68
US Patents:	19
Tradenames:	9
Applicants:	41
NDAs:	64
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	108
Patent Applications:	6,179
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
University of Calgary	Phase 3
Canadian Institutes of Health Research (CIHR)	Phase 3
University of Miami	Phase 2

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

Anatomical Therapeutic Chemical (ATC) Classes for KETOROLAC TROMETHAMINE

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

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	Ophthalmic 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
Sandoz	KETOROLAC TROMETHAMINE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	076583-001	Nov 5, 2009	AT	RX	No	No
Bionpharma	KETOROLAC TROMETHAMINE	ketorolac tromethamine	TABLET;ORAL	216759-001	Feb 23, 2023	AB	RX	No	No
Chartwell Rx	KETOROLAC TROMETHAMINE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	078434-001	Nov 5, 2009		DISCN	No	No
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes

Expired US Patents for KETOROLAC TROMETHAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992
Roche Palo	TORADOL	ketorolac tromethamine	TABLET;ORAL	019645-001	Dec 20, 1991
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003

International Patents for KETOROLAC TROMETHAMINE

Country	Patent Number	Title	Estimated Expiration
Spain	2593113
South Korea	101723703
Israel	207925	תכשירי קטורולק טרומתאמין לטיפול או מניעה של כאבי עיניים (Ketorolac tromethamine compositions for treating or preventing ocular pain)
European Patent Office	2113246	Compositions d'administration d'agents therapeutiques dans les yeux et leurs methodes d'elaboration et d'utilisation (Compositions for delivery of therapeutics into the eyes and methods for making and using the same)

Supplementary Protection Certificates for KETOROLAC TROMETHAMINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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