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Last Updated: August 14, 2022

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 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-one 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
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 AT RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Luitpold KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 078145-002 Jan 14, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 078737-002 Oct 6, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gland KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 204216-001 Nov 1, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Steriscience KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 078299-002 Jul 16, 2007 DISCN 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 PRESERVATIVE FREE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 020811-001 Nov 3, 1997 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 ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 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
Spain 2332049 See Plans and Pricing
Poland 2257275 See Plans and Pricing
Israel 207925 תכשירי קטורולק טרומתאמין לטיפול או מניעה של כאבי עיניים (Ketorolac tromethamine compositions for treating or preventing ocular pain) See Plans and Pricing
South Korea 20120058588 KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN See Plans and Pricing
South Korea 101560429 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 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 2015/071 Ireland See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313 CR 2015 00072 Denmark See Plans and Pricing PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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