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Profile for Tradename: SPRIX

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Sprix is a drug marketed by Luitpold and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in SPRIX is ketorolac tromethamine. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for Tradename: SPRIX

Patents:1
Applicants:1
NDAs:1
Suppliers: see list3

Pharmacology for Tradename: SPRIX

Clinical Trials for: SPRIX

Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine
Status: Recruiting Condition: Migraines

Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Status: Completed Condition: Postoperative Pain in Infants

Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain
Status: Enrolling by invitation Condition: Post Vasectomy Pain

Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures
Status: Recruiting Condition: Pain

Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
Status: Completed Condition: Acute Pain

Pharmacokinetics of Intranasal Ketorolac in Children
Status: Recruiting Condition: Evaluating Pharmacokinetics of Intranasal Ketorolac; Pain

The Use of Intranasal Ketoralac for Pain Management
Status: Recruiting Condition: Postoperative Pain Management; Urolithiasis

A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Status: Enrolling by invitation Condition: Chronic Pelvic Pain

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Status: Not yet recruiting Condition: Migraine

Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain
Status: Completed Condition: Interstitial Cystitis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Luitpold
SPRIX
ketorolac tromethamine
SPRAY, METERED;NASAL022382May 14, 2010RXYes6,333,044<disabled>Y<disabled>
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Paragraph IV activity for: SPRIX

Drugname Dosage Strength RLD Submissiondate
ketorolac tromethamineNasal Spray15.75 mg/spraySprix3/12/2012
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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