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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Teva
Federal Trade Commission
Medtronic
Baxter
Boehringer Ingelheim
Argus Health
Merck
AstraZeneca
Julphar

Generated: January 21, 2018

DrugPatentWatch Database Preview

Sevelamer hydrochloride - Generic Drug Details

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What are the generic drug sources for sevelamer hydrochloride and what is the scope of sevelamer hydrochloride patent protection?

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

Sevelamer hydrochloride has forty-one patent family members in thirty-one countries.

There are thirty-two drug master file entries for sevelamer hydrochloride. Five suppliers are listed for this compound.
Summary for sevelamer hydrochloride
Pharmacology for sevelamer hydrochloride

US Patents and Regulatory Information for sevelamer hydrochloride

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 sevelamer hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 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 021179-002 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 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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Non-Orange Book US Patents for sevelamer hydrochloride

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 sevelamer hydrochloride

Supplementary Protection Certificates for sevelamer hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606/01 Switzerland ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
C0011 France ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 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
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
C/GB02/011 United Kingdom ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

UBS
Covington
Medtronic
Fuji
Cerilliant
Healthtrust
Argus Health
Colorcon
McKinsey

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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