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OSMOPREP Drug Profile

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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-seven 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 and twenty-nine drug master file entries for this compound. Three 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 list2
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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Expired Patents for Tradename: OSMOPREP

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms
OSMOPREP
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021892-001Mar 16, 20065,616,346<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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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: OSMOPREP

Country Document Number Estimated Expiration
Japan5329042<disabled in preview>
Brazil122014001142<disabled in preview>
Australia2015221520<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OSMOPREP

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90062-5Sweden<disabled>PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
C0052France<disabled>PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C0041France<disabled>PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
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