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Serving leading biopharmaceutical companies globally:

Merck
Novartis
Johnson and Johnson
Daiichi Sankyo
Accenture
Citi
Dow
McKesson
Queensland Health
Argus Health

Generated: January 24, 2018

DrugPatentWatch Database Preview

RENAGEL Drug Profile

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When do Renagel patents expire, and when can generic versions of Renagel launch?

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

This drug has forty-one patent family members in thirty-one countries.

The generic ingredient in RENAGEL is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
Summary for RENAGEL
International Patents:41
US Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: 5
Clinical Trials: 18
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RENAGEL at DailyMed
Drug patent expirations by year for RENAGEL
Pharmacology for RENAGEL

US Patents and Regulatory Information for RENAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for RENAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 ➤ Subscribe ➤ Subscribe
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for RENAGEL
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 400 mg and 800 mg ➤ Subscribe 5/22/2008

Non-Orange Book US Patents for 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
8,187,631 Direct compression polymer tablet core ➤ Subscribe
9,579,343 Direct compression polymer tablet core ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for RENAGEL

Supplementary Protection Certificates for RENAGEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/011 United Kingdom ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
00428 Netherlands ➤ Subscribe PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
/2009 Austria ➤ Subscribe PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
C0011 France ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
2002 Austria ➤ Subscribe PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
00080 Netherlands ➤ Subscribe PRODUCT 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
0716606/01 Switzerland ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Novartis
Daiichi Sankyo
US Army
Boehringer Ingelheim
Express Scripts
Johnson and Johnson
UBS
Mallinckrodt

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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