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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Baxter
AstraZeneca
Dow
Chinese Patent Office
Fuji
Johnson and Johnson
Federal Trade Commission
US Army

Generated: July 22, 2018

DrugPatentWatch Database Preview

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 and is included in three NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has sixty-two patent family members in seventeen countries.

The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Drug patent expirations by year for WELCHOL
Pharmacology for WELCHOL
Medical Subject Heading (MeSH) Categories 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
Colesevelam hydrochloride [USAN]
FT-0697863
GT 31-104
GT 31-104HB
GT-31104
GT31-104
GT31-104HB
HS-0084
LS-74936
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 WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 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 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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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 ➤ Try a Free Trial
➤ Subscribe Tablets 625 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for WELCHOL

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
7,261,880 Methods of treating Syndrome X with aliphatic polyamines ➤ Try a Free Trial
8,377,428 Low salt forms of polyallylamine ➤ Try a Free Trial
7,541,024 Low salt forms of polyallylamine ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for WELCHOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00159 Netherlands ➤ Try a Free Trial PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
C0021 France ➤ Try a Free Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
C/GB04/031 United Kingdom ➤ Try a Free Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
McKinsey
Teva
Cantor Fitzgerald
QuintilesIMS
McKesson
Mallinckrodt
Chinese Patent Office
Daiichi Sankyo

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