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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
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Colorcon
US Department of Justice
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Generated: June 23, 2017

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Lanthanum carbonate - Generic Drug Details

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What are the generic drug sources for lanthanum carbonate and what is the scope of lanthanum carbonate freedom to operate?

Lanthanum carbonate
is the generic ingredient in one branded drug marketed by Shire Dev Llc and Shire Llc, and is included in two NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lanthanum carbonate has one hundred and four patent family members in thirty-five countries.

There are eight drug master file entries for lanthanum carbonate. Three suppliers are listed for this compound.

Summary for Generic Name: lanthanum carbonate

Tradenames:1
Patents:5
Applicants:2
NDAs:2
Drug Master File Entries: see list8
Suppliers / Packagers: see list3
Bulk Api Vendors: see list18
Clinical Trials: see list168
Patent Applications: see list1
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lanthanum carbonate at DailyMed

Pharmacology for Ingredient: lanthanum carbonate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-002Oct 26, 2004RXYesNo7,381,428► Subscribe ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-003Nov 23, 2005RXYesNo5,968,976► SubscribeY ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-001Oct 26, 2004DISCNNoNo7,381,428► Subscribe ► Subscribe
Shire Llc
FOSRENOL
lanthanum carbonate
TABLET, CHEWABLE;ORAL021468-002Oct 26, 2004RXYesNo5,968,976► SubscribeY ► Subscribe
Shire Dev Llc
FOSRENOL
lanthanum carbonate
POWDER;ORAL204734-002Sep 24, 2014RXYesYes5,968,976► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lanthanum carbonate

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 Ingredient: lanthanum carbonate

Country Document Number Estimated Expiration
Portugal2172205► Subscribe
BrazilPI0413394► Subscribe
European Patent Office2792363► Subscribe
Canada2536959► Subscribe
Mexico9707334► 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: LANTHANUM CARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/036United Kingdom► SubscribeSPC/GB06/036: 20061027
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
2008005Lithuania► SubscribePRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Harvard Business School
Baxter
Covington
Teva
Chubb
Johnson and Johnson
Fish and Richardson
Healthtrust
US Army

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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