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Profile for Tradename: OSMOPREP

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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-four patent family members in nine countries.

The generic ingredient in OSMOPREP is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand two hundred and seventy-three 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

Patents:1
Applicants:1
NDAs:1
Suppliers: see list2
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: Not yet recruiting Condition: Tendonitis; Bursitis

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
Salix Pharms
OSMOPREP
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021892-001Mar 16, 2006RXYes7,687,075<disabled>YY<disabled>
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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
8,507,009Colonic purgative composition with soluble binding agent<disabled in preview>
7,718,197Colonic purgative composition with soluble binding agent<disabled in preview>
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International Patent Family for Tradename: OSMOPREP

Country Document Number Publication Date
European Patent Office2308476Apr 13, 2011
South Korea20130048790May 10, 2013
China102648980Aug 29, 2012
South Korea20060114342Nov 06, 2006
China101087593Dec 12, 2007
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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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