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Last Updated: May 22, 2022

WELCHOL Drug Patent 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. Seventeen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Summary for WELCHOL
Drug patent expirations by year for WELCHOL
Drug Prices for WELCHOL

See drug prices for WELCHOL

Drug Sales Revenue Trends for WELCHOL

See drug sales revenues for WELCHOL

Recent Clinical Trials for WELCHOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Entera Health, IncPhase 2
Valeant Pharmaceuticals International, Inc.Phase 4
Bausch Health Americas, Inc.Phase 4

See all WELCHOL clinical trials

Paragraph IV (Patent) Challenges for WELCHOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
WELCHOL Powder for Oral Suspension colesevelam hydrochloride 1.875 g/Packet and 3.75 g/Packet 022362 1 2010-04-09
WELCHOL Tablets colesevelam hydrochloride 625 mg 021176 1 2009-07-01

US Patents and Regulatory Information for WELCHOL

WELCHOL is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting WELCHOL

Method for lowering serum glucose
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR REDUCING SERUM GLUCOSE LEVELS IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Method for lowering serum glucose
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting WELCHOL

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: See Plans and Pricing

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 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CAPSULE;ORAL 021141-001 May 26, 2000 See Plans and Pricing See Plans and Pricing
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 See Plans and Pricing See Plans and Pricing
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 See Plans and Pricing See Plans and Pricing
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for WELCHOL

See the table below for patents covering WELCHOL around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9534588 See Plans and Pricing
Mexico PA03009572 FORMAS DE POLIALILAMINA CON BAJO CONTENIDO EN SAL. (LOW SALT FORMS OF POLYALLYLAMINE.) See Plans and Pricing
European Patent Office 0764177 POLYMERES RETICULES CONTENANT COMPOSITION POUR ELIMINER LES SELS BILIAIRES D'UN PATIENT (CROSSLINKED POLYMER CONTAINING COMPOSITION FOR REMOVING BILE SALTS FROM A PATIENT) See Plans and Pricing
Brazil PI0209134 uso de um sevelamer ou um sal do mesmo e uso de um colesevelam ou um sal do mesmo See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for WELCHOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0764174 SPC013/2004 Ireland See Plans and Pricing SPC013/2004: 20050912, EXPIRES: 20190309
0764174 91100 Luxembourg See Plans and Pricing 91100, EXPIRES: 20190310
0764174 CA 2004 00027 Denmark See Plans and Pricing
0764174 04C0021 France See Plans and Pricing PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Mallinckrodt
Express Scripts
McKesson
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.