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Last Updated: October 20, 2019

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WELCHOL Drug Profile

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Which patents cover Welchol, and what generic alternatives are available?

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-three patent family members in eighteen countries.

The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Eleven 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
Valeant Pharmaceuticals International, Inc.Phase 4
LMC Diabetes & Endocrinology Ltd.Phase 4
Mayo ClinicPhase 3

See all WELCHOL clinical trials

Recent Litigation for WELCHOL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Daiichi Sankyo Inc. v. Impax Laboratories Inc.2010-01-14

See all WELCHOL litigation

Pharmacology for WELCHOL
Synonyms for WELCHOL
1-Hexaminium, N,N,N-trimethyl-6-(2-propenylamino)-, chloride, polymer with (chloromethyl)oxirane, 2-propen-4-amine and N-2-propenyl-1-decanamine, hydrochloride
1-Hexaminium,N,N,N-trimethyl-6-(2-propenylamino)-,chloride,polymer with (chloromethyl)oxirane,2-propen-4-amine and N-2-propenyl-1-decanamine, hdrochloride
2-(chloromethyl)oxirane; prop-2-en-1-amine; N-prop-2-enyldecan-1-amine; trimethyl-[6-(prop-2-enylamino)hexyl]azanium; chloride; hydrochloride
2-Propen-1-amine polymer with (chloromethyl)oxirane, N,N,N-trimethyl-6-(2-propenylamino)-1-hexanaminium chloride, and N-2-propenyl-1-decanamine, hydrochloride
6-(allylamino)hexyl-trimethyl-ammonium; n-allyldecan-1-amine; 2-(chloromethyl)oxirane; prop-2-en-1-amine; chloride; hydrochloride
AB01563397_01
AC1L4MYW
AC1Q1S4Z
Allylamine polymer with 1-chloro-2,3-epoxypropane, (6-(allylamino)hexyl)trimethylammonium chloride and N-allyldecylamine, hydrochloride
AN-30543
CholestaGel
Cholestagel, Colesevelam hydrochloride
Colesevelam HCl
Colesevelam hydrochloride [USAN]
FT-0697863
GT 31-104
GT 31-104HB
GT-31104
GT31-104
GT31-104HB
HS-0084
LS-74936
P4SG24WI5Q
UNII-P4SG24WI5Q
VTAKZNRDSPNOAU-UHFFFAOYSA-M

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
>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 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 TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for WELCHOL
Drugname Dosage Strength RLD Date
➤ Subscribe Powder for Oral Suspension 1.875 g/Packet and 3.75 g/Packet ➤ Subscribe   Start Trial
➤ Subscribe Tablets 625 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for WELCHOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0764174 SPC/GB04/031 United Kingdom   Start Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 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 04C0021 France   Start Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; 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:

McKinsey
Medtronic
Boehringer Ingelheim
Baxter
Mallinckrodt
McKesson

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