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Last Updated: August 9, 2020

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KETOROLAC TROMETHAMINE Drug Profile

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When do Ketorolac Tromethamine patents expire, and what generic alternatives are available?

Ketorolac Tromethamine is a drug marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz Inc, Sun Pharm, West-ward Pharms Int, Wockhardt, Akorn, Aurobindo Pharma Ltd, Micro Labs Ltd India, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, and Lupin Ltd. and is included in forty-three NDAs.

The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.

Drug patent expirations by year for KETOROLAC TROMETHAMINE
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

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SponsorPhase
Oman Medical Speciality BoardPhase 2/Phase 3
University of LouisvillePhase 4
Carilion ClinicPhase 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 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
West-ward Pharms Int KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075772-001 Jul 21, 2004 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 201155-002 Aug 4, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 078399-001 Nov 5, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Cycle Pharms Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 210616-001 Aug 16, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075772-002 Jul 21, 2004 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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