Deep knowledge on 
 small-molecule drugs and 
 the 110,000 global patents 
 covering them 

Free Patent Expiration Alerts


Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

SPRIX Drug Profile

« Back to Dashboard
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 eighteen drug master file entries for this compound. Forty-nine 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 / Packagers: see list3

Clinical Trials for: SPRIX

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

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: SPRIX

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Egalet Us Inc
SPRIX
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 14, 20107,476,689<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 Estimated Expiration
European Patent Office0524587<disabled in preview>
Austria130758<disabled in preview>
Spain2082288<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.

Supplementary Protection Certificates for Tradename: SPRIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00072Denmark<disabled>PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
923Luxembourg<disabled>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
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

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Connect with Social Media:

`abc