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

Subscribe to Free Drug Patent Expiration Updates

Also available in a Drug Patent Expiration NewsletterRSS feed and on Drug Patent Expirations on TwitterTwitter

DrugPatentWatch Ultimate Plan Preview

Profile for Tradename: OSMOPREP

« Back to Dashboard
Osmoprep is a drug marketed by Salix Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in nine countries.

The generic ingredient in OSMOPREP is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand three hundred drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.

Summary for Tradename: OSMOPREP

Suppliers / Packagers: see list3
Formulation / Manufacturing:see details

Clinical Trials for: OSMOPREP

Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Status: Active, not recruiting Condition: Colon Cleansing

Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy
Status: Terminated Condition: Colonoscopy

A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema
Status: Completed Condition: Colonoscopy

A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
Status: Completed Condition: Colonoscopy

Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing
Status: Completed Condition: Colon Cleansing

EryDex Pharmacokinetics in Healthy Volunteers
Status: Completed Condition: Healthy

Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis
Status: Recruiting Condition: Non-Infectious Anterior Uveitis

Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate
Status: Completed Condition: Healthy

Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Teleangiectasia Patients
Status: Completed Condition: Nervous System Disorder; Genetic Syndrome

Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder
Status: Withdrawn Condition: Tendonitis; Bursitis

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
Salix Pharms
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021892-001Mar 16, 2006RXYes7,687,075<disabled>YY <disabled>
This preview shows a limited data set
Subscribe for full access

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: OSMOPREP

Drugname Dosage Strength RLD Submissiondate
sodium phosphate monobasic monohydrate and sodium phosphatedibasic anhydrous, uspTablets1.102 g and 0.398 gOsmoprep4/9/2008

Non-Orange Book Patents for Tradename: OSMOPREP

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
7,718,197Colonic purgative composition with soluble binding agent<disabled in preview>
8,507,009Colonic purgative composition with soluble binding agent<disabled in preview>
This preview shows a limited data set
Subscribe for full access

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: OSMOPREP

Country Document Number Publication Date
Brazil122014001142Aug 18, 2015
World Intellectual Property Organization (WIPO)2005051361Jun 09, 2005
Japan2011173933Sep 08, 2011
Australia2011202346May 24, 2012
South Korea101268559May 31, 2013
This preview shows a limited data set
Subscribe for full access

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 free 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