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Last Updated: May 8, 2021

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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, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Nephron, Sagent Pharms Inc, Sandoz Inc, Sun Pharm, West-ward Pharms Int, Wockhardt, Roche Palo, Allergan, Akorn, Micro Labs Ltd India, Zyla, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, Lupin Ltd, and Omeros, and is included in fifty-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 eighteen 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
EMSPhase 2
Cairo UniversityPhase 1
Oman Medical Speciality BoardPhase 2/Phase 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 NDA Submissiondate
SPRIX SPRAY, METERED;NASAL ketorolac tromethamine 022382 2012-03-12
ACUVAIL SOLUTION/DROPS;OPHTHALMIC ketorolac tromethamine 022427 2011-08-24
ACULAR LS SOLUTION/DROPS;OPHTHALMIC ketorolac tromethamine 021528 2005-01-28
TORADOL TABLET;ORAL ketorolac tromethamine 019645
TORADOL INJECTABLE;INJECTION ketorolac tromethamine 019698

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
Watson Labs KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 074955-001 Sep 19, 1997 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Luitpold KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 078145-001 Jan 14, 2008 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Aurobindo Pharma Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 205191-001 Nov 15, 2018 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>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   Get Started for $10   Get Started for $10
Roche Palo TORADOL ketorolac tromethamine TABLET;ORAL 019645-001 Dec 20, 1991   Get Started for $10   Get Started for $10
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992   Get Started for $10   Get Started for $10
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992   Get Started for $10   Get Started for $10
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ketorolac tromethamine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 76/2015 Austria   Get Started for $10 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 C 2015 055 Romania   Get Started for $10 PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728
1534313 2015/071 Ireland   Get Started for $10 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
1534313 300784 Netherlands   Get Started for $10 PRODUCT NAME: EEN OCULAIRE OPLOSSING WELKE FENYLEFRINE BEVAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ALSMEDE KETOROLAC, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313 92923 Luxembourg   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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