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WELCHOL Drug Profile

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Welchol is a drug marketed by Daiichi Sankyo and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has fifty-eight patent family members in sixteen countries.

The generic ingredient in WELCHOL is colesevelam hydrochloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Summary for Tradename: WELCHOL

Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: see list4
Drug Prices: :see details

Pharmacology for Tradename: WELCHOL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
CAPSULE;ORAL021141-001May 26, 2000DISCNNo► subscribe► subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
TABLET;ORAL021176-001May 26, 2000RXYes7,229,613*PED► subscribeY► subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
FOR SUSPENSION;ORAL022362-001Oct 2, 2009RXNo7,229,613*PED► subscribeY► subscribe
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Expired Patents for Tradename: WELCHOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
TABLET;ORAL021176-001May 26, 20005,679,717*PED► subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
FOR SUSPENSION;ORAL022362-002Oct 2, 20095,919,832*PED► subscribe
Daiichi Sankyo
WELCHOL
colesevelam hydrochloride
TABLET;ORAL021176-001May 26, 20005,607,669*PED► subscribe
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Paragraph IV activity for: WELCHOL

Drugname Dosage Strength RLD Submissiondate
colesevelam hydrochloridePowder for Oral Suspension1.875 g/Packet and 3.75 g/PacketWelchol4/9/2010
colesevelam hydrochlorideTablets625 mgWelchol7/1/2009

Non-Orange Book Patents for Tradename: 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
7,261,880Methods of treating Syndrome X with aliphatic polyamines► subscribe
8,377,428Low salt forms of polyallylamine► subscribe
7,541,024Low salt forms of polyallylamine► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: WELCHOL

Country Document Number Estimated Expiration
Germany60225908► subscribe
New Zealand528829► subscribe
Australia2002257147► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: WELCHOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021France► subscribePRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
00159Netherlands► subscribePRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
C/GB04/031United Kingdom► subscribePRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
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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 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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