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Last Updated: March 29, 2024

WELCHOL Drug Patent Profile


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

Welchol is a drug marketed by Cosette and is included in four NDAs.

The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Sixteen 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
Entera Health, IncPhase 2
Valeant Pharmaceuticals International, Inc.Phase 4
Bausch Health Americas, Inc.Phase 4

See all WELCHOL clinical trials

Pharmacology for WELCHOL
Drug ClassBile Acid Sequestrant
Mechanism of ActionBile-acid Binding Activity
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 zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting WELCHOL

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cosette WELCHOL colesevelam hydrochloride BAR, CHEWABLE;ORAL 210895-001 Apr 3, 2019 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride BAR, CHEWABLE;ORAL 210895-001 Apr 3, 2019 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
>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
Canada 2444046 UTILISATION DU COLESEVELAM POUR REDUIRE LE GLUCOSE SERIQUE (USE OF COLESEVELAM IN REDUCING SERUM GLUCOSE) ⤷  Try a Trial
China 1290515 ⤷  Try a Trial
Australia 7047994 ⤷  Try a Trial
South Korea 100271693 ⤷  Try a Trial
Japan H10501264 ⤷  Try a Trial
Brazil 0209134 ⤷  Try a Trial
European Patent Office 0706399 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for WELCHOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0764174 91100 Luxembourg ⤷  Try a Trial 91100, EXPIRES: 20190310
0764174 04C0021 France ⤷  Try a Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
0764174 SPC/GB04/031 United Kingdom ⤷  Try a Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
0764174 300159 Netherlands ⤷  Try a Trial 300159, 20150605, EXPIRES: 20190309
0764174 SPC013/2004 Ireland ⤷  Try a Trial SPC013/2004: 20050912, EXPIRES: 20190309
0764174 CA 2004 00027 Denmark ⤷  Try a Trial
0764174 C300159 Netherlands ⤷  Try a Trial PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.