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Serving leading biopharmaceutical companies globally:

Harvard Business School
Julphar
Boehringer Ingelheim
Cerilliant
Healthtrust
Novartis
Dow
Daiichi Sankyo
McKinsey
Citi

Generated: December 13, 2017

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FOSRENOL Drug Profile

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When do Fosrenol patents expire, 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 twenty patent family members in thirty-five countries and three supplementary protection certificates in two countries.

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

Pharmacology for FOSRENOL

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Shire Dev LlcFOSRENOLlanthanum carbonatePOWDER;ORAL204734-002Sep 24, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Shire LlcFOSRENOLlanthanum carbonateTABLET, CHEWABLE;ORAL021468-003Nov 23, 2005ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcFOSRENOLlanthanum carbonatePOWDER;ORAL204734-001Sep 24, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcFOSRENOLlanthanum carbonatePOWDER;ORAL204734-002Sep 24, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Shire LlcFOSRENOLlanthanum carbonateTABLET, CHEWABLE;ORAL021468-001Oct 26, 2004DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire LlcFOSRENOLlanthanum carbonateTABLET, CHEWABLE;ORAL021468-003Nov 23, 2005ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcFOSRENOLlanthanum carbonatePOWDER;ORAL204734-001Sep 24, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire LlcFOSRENOLlanthanum carbonateTABLET, CHEWABLE;ORAL021468-003Nov 23, 2005ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Shire LlcFOSRENOLlanthanum carbonateTABLET, CHEWABLE;ORAL021468-002Oct 26, 2004ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Shire LlcFOSRENOLlanthanum carbonateTABLET, CHEWABLE;ORAL021468-001Oct 26, 2004DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
Estonia9700325► Subscribe
BrazilPI0413394► Subscribe
World Intellectual Property Organization (WIPO)2007054782► Subscribe
Denmark200600252► Subscribe
Taiwan436288► Subscribe
Canada2816626► Subscribe
Austria9809► Subscribe
Argentina056609► Subscribe
Japan3224544► Subscribe
Japan2013544287► 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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Serving leading biopharmaceutical companies globally:

Cipla
Harvard Business School
Merck
Argus Health
Chinese Patent Office
McKinsey
UBS
Queensland Health
Medtronic
Deloitte

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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