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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Cerilliant
McKesson
McKinsey
Dow
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US Army
Mallinckrodt
Boehringer Ingelheim
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Generated: August 23, 2017

DrugPatentWatch Database Preview

OSMOPREP Drug Profile

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Which patents cover Osmoprep, and what generic Osmoprep alternatives are available?

Osmoprep is a drug marketed by Salix Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eleven countries.

The generic ingredient in OSMOPREP is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand three hundred and ninety-two 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
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OSMOPREP at DailyMed

Pharmacology for Tradename: OSMOPREP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS 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, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: OSMOPREP

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, 2006► Subscribe► Subscribe
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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► Subscribe
8,507,009Colonic purgative composition with soluble binding agent► Subscribe
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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
South Korea101495690► Subscribe
South Korea101323628► Subscribe
South Korea101268559► Subscribe
European Patent Office2308476► Subscribe
Australia2015221520► Subscribe
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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
666Luxembourg► SubscribePRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
90018-6Sweden► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
99C0030Belgium► SubscribePRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
C/GB08/036United Kingdom► SubscribePRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
C0076France► SubscribePRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Colorcon
Merck
Cipla
Johnson and Johnson
McKinsey
Queensland Health
Chinese Patent Office
Moodys
Cantor Fitzgerald

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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