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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
AstraZeneca
Moodys
Cipla
Johnson and Johnson
Harvard Business School
Fuji
Teva
Express Scripts

Generated: January 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. Five 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
Pharmacology for WELCHOL
Medical Subject Heading (MeSH) Categories for WELCHOL

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 TABLET;ORAL 021176-001 May 26, 2000 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ➤ Subscribe ➤ Subscribe
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Subscribe ➤ Subscribe
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 Submissiondate
➤ Subscribe Powder for Oral Suspension 1.875 g/Packet and 3.75 g/Packet ➤ Subscribe 4/9/2010
➤ Subscribe Tablets 625 mg ➤ Subscribe 7/1/2009

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 ➤ Subscribe
7,541,024 Low salt forms of polyallylamine ➤ Subscribe
8,377,428 Low salt forms of polyallylamine ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for WELCHOL

Supplementary Protection Certificates for WELCHOL

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

Chubb
US Department of Justice
US Army
Boehringer Ingelheim
Johnson and Johnson
Harvard Business School
Healthtrust
Novartis
Cipla

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 verifification 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.

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