Ketorolac tromethamine - Generic Drug Details

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What are the generic sources for ketorolac tromethamine and what is the scope of freedom to operate?

Ketorolac tromethamine is the generic ingredient in nine branded drugs marketed by Alembic Pharms, Amphastar Pharm, Apotex Inc, Apothecon, 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, Wockhardt Bio Ag, Roche Palo, Allergan, Akorn, Micro Labs Ltd India, Zyla, Atnahs Pharma Us, Cycle, Hetero Labs Ltd Iii, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Zydus, Lupin Ltd, and Rayner Surgical, and is included in fifty-nine 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-two suppliers are listed for this compound.

Summary for ketorolac tromethamine

International Patents:	68
US Patents:	19
Tradenames:	9
Applicants:	36
NDAs:	59
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	62
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	105
Patent Applications:	6,824
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

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Drug Sales Revenue Trends for ketorolac tromethamine

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Recent Clinical Trials for ketorolac tromethamine

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

Sponsor	Phase
McMaster University	Phase 3
Hamilton Health Sciences Corporation	Phase 3
Andrew Hendifar, MD	Early 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

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	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Steriscience	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	078299-001	Jul 16, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare Corp	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	209900-002	Jul 25, 2018	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Sagent Pharms Inc	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	091065-002	Nov 27, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex Inc	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	077201-001	Oct 14, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075772-001	Jul 21, 2004	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ketorolac tromethamine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Try a Trial	⤷ Try a Trial
Allergan	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Try a Trial	⤷ Try a Trial
Allergan	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Try a Trial	⤷ Try a Trial
Allergan	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	⤷ Try a Trial	⤷ Try a Trial
Roche Palo	TORADOL	ketorolac tromethamine	TABLET;ORAL	019645-001	Dec 20, 1991	⤷ Try a Trial	⤷ Try a Trial
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ketorolac tromethamine

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Country	Patent Number	Title	Estimated Expiration
South Korea	101560429		⤷ Try a Trial
Canada	2717520	COMPOSITIONS DE KETOROLAC TROMETHAMINE POUR TRAITER OU PREVENIR LES DOULEURS OCULAIRES (KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011127196		⤷ Try a Trial
Japan	5705552		⤷ Try a Trial
Japan	2007501799		⤷ Try a Trial
European Patent Office	3217937	SYSTÈMES DE LIT (BED SYSTEMS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ketorolac tromethamine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	76/2015	Austria	⤷ Try a Trial	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	2015/071	Ireland	⤷ Try a Trial	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	CR 2015 00072	Denmark	⤷ Try a Trial	PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	92923	Luxembourg	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	15C0090	France	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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