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Last Updated: August 6, 2020

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WELCHOL Drug Profile

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Which patents cover Welchol, and when can generic versions of Welchol launch?

Welchol is a drug marketed by Daiichi Sankyo Inc and Daiichi Sankyo and is included in four NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-four patent family members in eighteen countries.

The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Drug patent expirations by year for WELCHOL
Drug Prices for WELCHOL

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Drug Sales Revenue Trends for WELCHOL

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Recent Clinical Trials for WELCHOL

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SponsorPhase
LMC Diabetes & Endocrinology Ltd.Phase 4
Valeant Pharmaceuticals International, Inc.Phase 4
Mayo ClinicPhase 3

See all WELCHOL clinical trials

Pharmacology for WELCHOL
Paragraph IV (Patent) Challenges for WELCHOL
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 WELCHOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo Inc WELCHOL colesevelam hydrochloride BAR, CHEWABLE;ORAL 210895-001 Apr 3, 2019 RX Yes Yes   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
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   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 WELCHOL

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

Supplementary Protection Certificates for WELCHOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0764174 300159 Netherlands   Start Trial 300159, 20150605, EXPIRES: 20190309
0764174 CA 2004 00027 Denmark   Start Trial
0764174 04C0021 France   Start Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
0764174 91100 Luxembourg   Start Trial 91100, EXPIRES: 20190310
0764174 SPC/GB04/031 United Kingdom   Start Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
0764174 SPC013/2004 Ireland   Start Trial SPC013/2004: 20050912, EXPIRES: 20190309
0764174 C300159 Netherlands   Start Trial PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Mallinckrodt
Express Scripts
McKesson
Johnson and Johnson

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