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Generated: December 18, 2018

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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 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. Twelve 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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 022362-002 Oct 2, 2009 ➤ Sign Up ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Sign Up ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Sign Up ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ➤ Sign Up ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ➤ Sign Up ➤ Sign Up
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up
➤ Subscribe Tablets 625 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for WELCHOL

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

Farmers Insurance
Medtronic
Healthtrust
Cantor Fitzgerald
Fuji
Merck
Argus Health
US Army
Dow

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