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Last Updated: October 26, 2020

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SEVELAMER HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for sevelamer hydrochloride and what is the scope of freedom to operate?

Sevelamer hydrochloride is the generic ingredient in two branded drugs marketed by Genzyme and Glenmark Pharms Ltd, and is included in three 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. Four suppliers are listed for this compound.

Recent Clinical Trials for SEVELAMER HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shanghai Alebund Pharmaceuticals LimitedPhase 2
Akebia TherapeuticsPhase 1
Shandong Weigao Panion Pharmaceutical Co. Ltd.Phase 3

See all SEVELAMER HYDROCHLORIDE clinical trials

Pharmacology for SEVELAMER HYDROCHLORIDE
Paragraph IV (Patent) Challenges for SEVELAMER HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
RENAGEL TABLET;ORAL sevelamer hydrochloride 021179 2008-05-22

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 TABLET;ORAL 021179-002 Jul 12, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glenmark Pharms Ltd SEVELAMER HYDROCHLORIDE sevelamer hydrochloride TABLET;ORAL 204724-001 Feb 8, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glenmark Pharms Ltd SEVELAMER HYDROCHLORIDE sevelamer hydrochloride TABLET;ORAL 204724-002 Feb 8, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for SEVELAMER HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 SPC/GB02/011 United Kingdom   Start Trial PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
0716606 02C0011 France   Start Trial PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606 C300080 Netherlands   Start Trial 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 C300428 Netherlands   Start Trial PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606 49/2009 Austria   Start Trial PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606 6/2002 Austria   Start Trial PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Express Scripts
Colorcon
Harvard Business School
McKesson

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