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Last Updated: August 10, 2020

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COLESEVELAM HYDROCHLORIDE - Generic Drug Details

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

Colesevelam hydrochloride is the generic ingredient in two branded drugs marketed by Daiichi Sankyo Inc, Daiichi Sankyo, Alkem Labs Ltd, Glenmark Pharms Ltd, Bionpharma Inc, Dr Reddys, Impax Labs Inc, Invagen Pharms, and Zydus Pharms, and is included in thirteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colesevelam hydrochloride has sixty-four patent family members in eighteen countries.

There are ten drug master file entries for colesevelam hydrochloride. Fourteen suppliers are listed for this compound.

Summary for COLESEVELAM HYDROCHLORIDE
Recent Clinical Trials for COLESEVELAM HYDROCHLORIDE

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

SponsorPhase
Herlev and Gentofte HospitalPhase 4
Filip Krag KnopPhase 4
Lars Kristian MunckPhase 4

See all COLESEVELAM HYDROCHLORIDE clinical trials

Pharmacology for COLESEVELAM HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for COLESEVELAM HYDROCHLORIDE
Paragraph IV (Patent) Challenges for COLESEVELAM HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
WELCHOL FOR SUSPENSION;ORAL colesevelam hydrochloride 022362 2010-04-09
WELCHOL TABLET;ORAL colesevelam hydrochloride 021176 2009-07-01

US Patents and Regulatory Information for COLESEVELAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride FOR SUSPENSION;ORAL 202190-002 Jul 16, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 212602-001 Apr 20, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dr Reddys COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 210889-001 Oct 5, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride FOR SUSPENSION;ORAL 210316-001 May 6, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 207765-001 Oct 7, 2019 AB RX 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 COLESEVELAM HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for COLESEVELAM HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0764174 04C0021 France   Start Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
0764174 C300159 Netherlands   Start Trial PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
0764174 SPC/GB04/031 United Kingdom   Start Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
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Harvard Business School
Mallinckrodt
Moodys
Medtronic

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