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Last Updated: March 28, 2024

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, 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.

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
Hamilton Health Sciences CorporationPhase 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
Teva KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 074754-001 May 16, 1997 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075299-001 Nov 3, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 078721-001 Nov 5, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 204216-002 Nov 1, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Senores Pharms KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 215788-001 Mar 23, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 203376-001 Feb 10, 2014 DISCN 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ACULAR PRESERVATIVE FREE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 020811-001 Nov 3, 1997 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ⤷  Try a Trial ⤷  Try a Trial
Zyla SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo TORADOL ketorolac tromethamine TABLET;ORAL 019645-001 Dec 20, 1991 ⤷  Try a Trial ⤷  Try a Trial
Zyla SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ketorolac tromethamine

Country Patent Number Title Estimated Expiration
Germany 602004023516 ⤷  Try a Trial
European Patent Office 2555770 COMPOSITIONS DE KÉTOROLAC POUR LA CICATRISATION DE LÉSIONS CORNÉENNES (KETOROLAC COMPOSITIONS FOR CORNEAL WOUND HEALING) ⤷  Try a Trial
European Patent Office 2446878 Compositions de kétorolac trométhamine pour traiter ou prévenir la douleur oculaire (Ketorolac tromethamine compositions for treating or preventing ocular pain) ⤷  Try a Trial
Canada 2534484 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 SAME) ⤷  Try a Trial
New Zealand 602445 Ketorolac tromethamine compositions for treating or preventing ocular pain ⤷  Try a Trial
European Patent Office 2473157 COMPOSITIONS DE KÉTOROLAC TROMÉTHAMINE POUR TRAITER OU PRÉVENIR LA DOULEUR OCULAIRE (KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ketorolac tromethamine

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

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