.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Baxter
Cerilliant
Harvard Business School
Merck
Julphar
Citi
McKinsey
Fuji

Generated: December 17, 2017

DrugPatentWatch Database Preview

OSMOPREP Drug Profile

« Back to Dashboard

Which patents cover Osmoprep, and what generic 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-nine patent family members in eleven countries and twenty-nine supplementary protection certificates in seven countries.

The generic ingredient in OSMOPREP is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand four hundred 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix PharmsOSMOPREPsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrateTABLET;ORAL021892-001Mar 16, 2006RXYesYes► Subscribe► SubscribeYY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: OSMOPREP

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005051361► Subscribe
Australia2004292428► Subscribe
Australia2011202346► Subscribe
Argentina046651► Subscribe
Brazil122014001142► Subscribe
BrazilPI0416702► Subscribe
Japan5329042► Subscribe
Spain2584866► Subscribe
Japan2014065746► Subscribe
China102648980► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: OSMOPREP

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
666Luxembourg► SubscribePRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
C0041France► SubscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
2015 00014Denmark► 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
90062-5Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
C/GB97/078United Kingdom► SubscribePRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Teva
Argus Health
Cerilliant
Colorcon
UBS
Accenture
Cipla
Daiichi Sankyo

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot