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Profile for Tradename: SPRIX

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

This drug has nine patent family members in eight countries.

The generic ingredient in SPRIX is ketorolac tromethamine. There are seventeen 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: Active, not recruiting Condition: Migraines

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

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

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

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

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Status: Recruiting Condition: Migraine

An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Status: Active, not recruiting Condition: Other Acute Pain

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Egalet Us Inc
SPRIX
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 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

Non-Orange Book Patents for Tradename: SPRIX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,267,827Therapeutic compositions for intranasal administration which include KETOROLAC<disabled in preview>
7,476,689Therapeutic compositions for intranasal administration which include KETOROLAC<disabled in preview>
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International Patent Family for Tradename: SPRIX

Country Document Number Publication Date
Spain2082288Mar 16, 1996
Germany69206345Apr 25, 1996
Austria130758Dec 15, 1995
European Patent Office0524587Nov 29, 1995
European Patent Office0524587Jan 27, 1993
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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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