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Last Updated: April 19, 2024

Ketorolac tromethamine - Generic Drug Details

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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 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, 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, Lupin Ltd, and Rayner Surgical, and is included in sixty-three 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:	63
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	68
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	107
Patent Applications:	5,544
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
University of Miami	Phase 2
Chung-Ang University Gwangmyeong Hospital	N/A
Hamilton Health Sciences Corporation	Phase 3

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	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
Baxter Hlthcare Corp	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	075631-002	Jun 29, 2001		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roche Palo	TORADOL	ketorolac tromethamine	INJECTABLE;INJECTION	019698-001	Nov 30, 1989		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Hetero Labs Ltd Iii	KETOROLAC TROMETHAMINE	ketorolac tromethamine	TABLET;ORAL	216651-001	Aug 25, 2022	AB	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
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ 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
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)	⤷ Try a Trial
Spain	2593113		⤷ Try a Trial
Austria	444732		⤷ Try a Trial
Israel	207925	תכשירי קטורולק טרומתאמין לטיפול או מניעה של כאבי עיניים (Ketorolac tromethamine compositions for treating or preventing ocular pain)	⤷ 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	122015000111	Germany	⤷ Try a Trial	PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	CA 2015 00072	Denmark	⤷ Try a Trial	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	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
1534313	C 2015 055	Romania	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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