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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 eigthy-eight 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 / Packagers: see list3
Formulation / Manufacturing:see details

Clinical Trials for: OSMOPREP

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
7,718,197Colonic purgative composition with soluble binding agent<disabled in preview>
8,507,009Colonic purgative composition with soluble binding agent<disabled in preview>
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International Patent Family for Tradename: OSMOPREP

Country Document Number Publication Date
South Korea20120045015May 08, 2012
World Intellectual Property Organization (WIPO)2005051361Jun 09, 2005
European Patent Office1682098Jul 26, 2006
Australia2012202628May 24, 2012
Japan5502807May 28, 2014
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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