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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Covington
Queensland Health
Deloitte
Federal Trade Commission
Fuji
Daiichi Sankyo
Julphar
Boehringer Ingelheim

Generated: May 25, 2018

DrugPatentWatch Database Preview

Colesevelam hydrochloride - Generic Drug Details

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

Colesevelam hydrochloride
is the generic ingredient in two branded drugs marketed by Daiichi Sankyo and Impax Labs Inc, and is included in four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Colesevelam hydrochloride has sixty-two patent family members in seventeen countries.

There are ten drug master file entries for colesevelam hydrochloride. Six suppliers are listed for this compound.
Pharmacology for colesevelam hydrochloride
Medical Subject Heading (MeSH) Categories for colesevelam hydrochloride
Synonyms for colesevelam 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, 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
UNII-P4SG24WI5Q
VTAKZNRDSPNOAU-UHFFFAOYSA-M
Welchol

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
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 022362-002 Oct 2, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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
Impax Labs Inc COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 091600-001 May 16, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 colesevelam hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 CAPSULE;ORAL 021141-001 May 26, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 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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Non-Orange Book US Patents for colesevelam hydrochloride

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
8,377,428 Low salt forms of polyallylamine ➤ Try a Free Trial
7,261,880 Methods of treating Syndrome X with aliphatic polyamines ➤ 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 colesevelam hydrochloride

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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Dow
Julphar
AstraZeneca
Deloitte
Harvard Business School
US Department of Justice
US Army
Express Scripts

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