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Serving 500+ biopharmaceutical companies globally:

UBS
US Army
Cipla
Daiichi Sankyo
Express Scripts
Deloitte
Cantor Fitzgerald
Farmers Insurance
Colorcon
Dow

Generated: August 23, 2017

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FOSRENOL Drug Profile

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What is the patent landscape for Fosrenol, and when can generic versions of Fosrenol launch?

Fosrenol is a drug marketed by Shire Dev Llc and Shire Llc and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and four patent family members in thirty-five countries.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for Tradename: FOSRENOL

Patents:5
Applicants:2
NDAs:2
Suppliers / Packagers: see list3
Bulk Api Vendors: see list17
Clinical Trials: see list23
Patent Applications: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FOSRENOL at DailyMed

Pharmacology for Tradename: FOSRENOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Dev Llc
FOSRENOL
lanthanum carbonate
POWDER;ORAL204734-002Sep 24, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-003Nov 23, 2005RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Dev Llc
FOSRENOL
lanthanum carbonate
POWDER;ORAL204734-001Sep 24, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Dev Llc
FOSRENOL
lanthanum carbonate
POWDER;ORAL204734-002Sep 24, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-001Oct 26, 2004DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-003Nov 23, 2005RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Dev Llc
FOSRENOL
lanthanum carbonate
POWDER;ORAL204734-001Sep 24, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-003Nov 23, 2005RXYesNo► Subscribe► Subscribe ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-002Oct 26, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-001Oct 26, 2004DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV activity for: FOSRENOL

Drugname Dosage Strength RLD Submissiondate
lanthanum carbonateOral Powder750 mg and 1000 mgFosrenol11/25/2015
lanthanum carbonateChewable Tablet500 mg, 750 mg and 1000 mgFosrenol10/27/2008

Non-Orange Book Patents for Tradename: FOSRENOL

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
8,263,119Capsule formulations containing lanthanum compounds► Subscribe
8,697,132Capsule and powder formulations containing lanthanum compounds► 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: FOSRENOL

Country Document Number Estimated Expiration
Czech Republic17621► Subscribe
Eurasian Patent Organization200600479► Subscribe
Argentina056609► Subscribe
South Korea20130119960► Subscribe
Australia2006313490► Subscribe
Australia2004266050► Subscribe
Slovenia2172205► Subscribe
Norway20061347► Subscribe
Norway974425► Subscribe
China103237543► 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: FOSRENOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008005Lithuania► SubscribePRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
2008005,C0817639Lithuania► SubscribePRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029
C/GB06/036United Kingdom► SubscribeSPC/GB06/036: 20061027
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Healthtrust
Dow
Novartis
Harvard Business School
Mallinckrodt
Fuji
Boehringer Ingelheim
Merck
McKinsey

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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