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Sevelamer carbonate - Generic Drug Details

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Sevelamer carbonate is the generic ingredient in one branded drug marketed by Genzyme and is included in two NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are thirty-one drug master file entries for sevelamer carbonate. Six suppliers are listed for this compound.

Summary for Generic Name: sevelamer carbonate

Tradenames:1
Patents:2
Applicants:1
NDAs:2
Drug Master File Entries: see list31
Suppliers / Packaging: see list6
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: sevelamer carbonate

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
TABLET;ORAL022127-001Oct 19, 2007RXYes7,985,418► subscribeY ► subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009RXNo9,095,509► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: sevelamer carbonate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 20097,014,846► subscribe
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 20076,509,013► subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20095,496,545► subscribe
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Non-Orange Book Patents for Generic Ingredient: sevelamer 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
8,808,738Aliphatic 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 Ingredient: sevelamer carbonate

Country Document Number Estimated Expiration
Japan2009508580► subscribe
South Korea101574072► subscribe
South Korea20140139121► 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: SEVELAMER CARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0011France► subscribePRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606/01Switzerland► subscribePRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
2002Austria► subscribePRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
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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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