Deep knowledge on
small-molecule drugs and
the 90,000 global patents
covering them

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Profile for Tradename: SPRIX

« Back to Dashboard
Sprix is a drug marketed by Egalet Us Inc and is included in one NDA. It is available from four 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. Eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for Tradename: SPRIX

Suppliers / Packagers: see list4

Pharmacology for Tradename: SPRIX

Clinical Trials for: SPRIX

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

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

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

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

Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients
Status: Recruiting Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Courtesy of
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
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 14, 2010RXYes6,333,044<disabled>Y <disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: SPRIX

Country Document Number Publication Date
ItalyMI912024Jan 23, 1993
Spain2082288Mar 16, 1996
Greece3019012May 31, 1996
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a trial or see the database preview and plan comparison

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn