KETOROLAC TROMETHAMINE - Generic Drug Details

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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

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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
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

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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
Epic Pharma Llc	KETOROLAC TROMETHAMINE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	078399-001	Nov 5, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare Corp	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	209900-001	Sep 15, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bedford	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075230-001	Oct 25, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075228-001	Apr 26, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	074802-001	Jun 5, 1997	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075784-002	Jan 11, 2002	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	⤷ Sign Up	⤷ Sign Up
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010	⤷ Sign Up	⤷ Sign Up
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Sign Up	⤷ Sign Up
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997	⤷ Sign Up	⤷ Sign Up
Roche Palo	TORADOL	ketorolac tromethamine	TABLET;ORAL	019645-001	Dec 20, 1991	⤷ Sign Up	⤷ Sign Up
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009	⤷ Sign Up	⤷ Sign Up
>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
Canada	2796071	COMPOSITIONS DE KETOROLAC POUR LA CICATRISATION DE LESIONS CORNEENNES (KETOROLAC COMPOSITIONS FOR CORNEAL WOUND HEALING)	⤷ Sign Up
China	102014869	Ketorolac tromethamine compositions for treating or preventing ocular pain	⤷ Sign Up
Spain	2566162		⤷ Sign Up
Hungary	E027102		⤷ Sign Up
Denmark	2446878		⤷ Sign Up
Japan	2013503873		⤷ Sign Up
>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	C 2015 055	Romania	⤷ Sign Up	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	CR 2015 00072	Denmark	⤷ Sign Up	PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	92923	Luxembourg	⤷ Sign Up	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	76/2015	Austria	⤷ Sign Up	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	⤷ Sign Up	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	15C0090	France	⤷ Sign Up	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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