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RENAGEL Drug Profile

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Renagel is a drug marketed by Genzyme and is included in two NDAs. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in thirty countries.

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

Summary for Tradename: RENAGEL

Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list4
Drug Prices: :see details

Pharmacology for Tradename: RENAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme
RENAGEL
sevelamer hydrochloride
CAPSULE;ORAL020926-001Oct 30, 1998DISCNNo► subscribe► subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 2000RXNo6,733,780► subscribeY ► subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 2000RXYes6,733,780► subscribeY ► subscribe
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Expired Patents for Tradename: RENAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20006,509,013► subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
CAPSULE;ORAL020926-001Oct 30, 19985,496,545► subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20005,667,775► subscribe
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Paragraph IV activity for: RENAGEL

Drugname Dosage Strength RLD Submissiondate
sevelamer hydrochlorideTablets400 mg and 800 mgRenagel5/22/2008

Non-Orange Book Patents for Tradename: RENAGEL

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
8,187,631Direct compression polymer tablet core► 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: RENAGEL

Country Document Number Estimated Expiration
Japan5583110► subscribe
Hungary0203334► subscribe
Norway20021827► 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: RENAGEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0011France► subscribePRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
00080Netherlands► subscribePRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128
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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