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Last Updated: May 19, 2022

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 Amphastar Pharm, Apotex Inc, Apothecon, Atlantide, 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, Roche Palo, Allergan, Akorn, Micro Labs Ltd India, Zyla, Cycle Pharms Ltd, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Lupin Ltd, and Rayner Surgical, and is included in fifty-five 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. Fifty suppliers are listed for this compound.

Drug Prices for ketorolac tromethamine

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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

SponsorPhase
Andrew Hendifar, MDEarly Phase 1
NEMA Research, Inc.Phase 3
St. Louis UniversityN/A

See all ketorolac tromethamine clinical trials

Pharmacology for ketorolac tromethamine
Medical Subject Heading (MeSH) Categories for ketorolac tromethamine
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo TORADOL ketorolac tromethamine INJECTABLE;INJECTION 019698-001 Nov 30, 1989 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cycle Pharms Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 210616-001 Aug 16, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 203242-001 Oct 7, 2015 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Zyla SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 See Plans and Pricing See Plans and Pricing
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 See Plans and Pricing See Plans and Pricing
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 See Plans and Pricing See Plans and Pricing
Roche Palo TORADOL ketorolac tromethamine TABLET;ORAL 019645-001 Dec 20, 1991 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ketorolac tromethamine

Country Patent Number Title Estimated Expiration
New Zealand 588367 KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN See Plans and Pricing
European Patent Office 1654002 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) See Plans and Pricing
China 102497856 Ketorolac tromethamine compositions for treating or preventing ocular pain See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009111418 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ketorolac tromethamine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 15C0090 France See Plans and Pricing 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 122015000111 Germany See Plans and Pricing PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 92923 Luxembourg See Plans and Pricing 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 C 2015 055 Romania See Plans and Pricing 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.