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-eight 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:	68
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
Hospira	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	074802-001	Jun 5, 1997	AP	RX	No	Yes
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y
Roche Palo	TORADOL	ketorolac tromethamine	INJECTABLE;INJECTION	019698-001	Nov 30, 1989		DISCN	Yes	No
Eugia Pharma	KETOROLAC TROMETHAMINE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	205190-001	Dec 3, 2020		DISCN	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
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009

International Patents for KETOROLAC TROMETHAMINE

Country	Patent Number	Title	Estimated Expiration
Hungary	E027102
European Patent Office	3777808	SYSTÈMES DE LIT (BED SYSTEMS)
Ukraine	97734	КОМПОЗИЦИИ КЕТОРОЛАКА ТРОМЕТАМИНА ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ ГЛАЗНОЙ БОЛИ;КОМПОЗИЦІЇ КЕТОРОЛАКУ ТРОМЕТАМІНУ ДЛЯ ЛІКУВАННЯ АБО ПРОФІЛАКТИКИ ОЧНОГО БОЛЮ (KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN)
South Korea	20120058588	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	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