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Last Updated: May 23, 2024

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, 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 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.

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
University of MiamiPhase 2
Chung-Ang University Gwangmyeong HospitalN/A
McMaster UniversityPhase 3

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 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
Lupin Ltd KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 210183-001 Jul 1, 2019 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sandoz KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 076271-002 Oct 6, 2004 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ⤷  Sign Up ⤷  Sign Up
Zyla SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ketorolac tromethamine

Country Patent Number Title Estimated Expiration
South Korea 20120058588 KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN ⤷  Sign Up
Colombia 6321226 COMPOSICIONES DE KETOROLAC TROMETAMINA PARA TRATAR O PREVENIR EL DOLOR OCULAR ⤷  Sign Up
Denmark 2446878 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ketorolac tromethamine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
>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.