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RENVELA Drug Profile

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Renvela is a drug marketed by Genzyme and is included in two NDAs. It is available from six suppliers. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in sixteen countries.

The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for Tradename: RENVELA

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list6
Drug Prices: :see details

Pharmacology for Tradename: RENVELA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 2009RXYes9,095,509► subscribeY ► subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009RXNo9,095,509► subscribeY ► subscribe
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 2007RXYes7,985,418► subscribeY ► subscribe
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Expired Patents for Tradename: RENVELA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20096,858,203► subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20095,496,545► subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20095,667,775► subscribe
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Paragraph IV activity for: RENVELA

Drugname Dosage Strength RLD Submissiondate
sevelamer carbonatePowder for Oral Suspension0.8 g/packet and 2.4 g/packetRenvela12/30/2009
sevelamer carbonateTablets800 mgRenvela12/4/2008

Non-Orange Book Patents for Tradename: RENVELA

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
8,808,738Aliphatic amine polymer salts for tableting► 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: RENVELA

Country Document Number Estimated Expiration
Japan2014193926► subscribe
Canada2762076► subscribe
Canada2586023► 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: RENVELA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2009Austria► subscribePRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
00428Netherlands► subscribePRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
C/GB02/011United Kingdom► subscribePRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
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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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