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Last Updated: November 30, 2022

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 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, Hetero Labs Ltd Iii, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Lupin Ltd, and Rayner Surgical, and is included in fifty-six 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-two 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
Nuance Pharma (shanghai) Co., LtdPhase 1

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
Eugia Pharma KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 212939-001 Oct 20, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 078737-001 Oct 6, 2008 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
Mylan KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 074761-001 May 16, 1997 AB RX No No See Plans and Pricing See Plans and Pricing 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
Zyla SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 See Plans and Pricing See Plans and Pricing
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 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
Canada 2796071 COMPOSITIONS DE KETOROLAC POUR LA CICATRISATION DE LESIONS CORNEENNES (KETOROLAC COMPOSITIONS FOR CORNEAL WOUND HEALING) See Plans and Pricing
South Korea 20100130989 KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN See Plans and Pricing
Slovenia 2555770 See Plans and Pricing
European Patent Office 2446878 Compositions de kétorolac trométhamine pour traiter ou prévenir la douleur oculaire (Ketorolac tromethamine compositions for treating or preventing ocular pain) 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 76/2015 Austria See Plans and Pricing 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 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 122015000111 Germany See Plans and Pricing PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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