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Serving hundreds of leading biopharmaceutical companies globally:

Teva
QuintilesIMS
Cerilliant
McKesson
McKinsey
Colorcon
Federal Trade Commission
UBS
Express Scripts

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021176

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NDA 021176 describes WELCHOL, which is a drug marketed by Daiichi Sankyo and is included in three NDAs. It is available from five suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the WELCHOL profile page.

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 021176
Tradename:WELCHOL
Applicant:Daiichi Sankyo
Ingredient:colesevelam hydrochloride
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021176
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 021176
Suppliers and Packaging for NDA: 021176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WELCHOL colesevelam hydrochloride TABLET;ORAL 021176 NDA Rebel Distributors Corp 21695-781 E 21695-781-78
WELCHOL colesevelam hydrochloride TABLET;ORAL 021176 NDA Physicians Total Care, Inc. 54868-4474 E 54868-4474-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength625MG
Approval Date:May 26, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 17, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021176

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 TABLET;ORAL 021176-001 May 26, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
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 TABLET;ORAL 021176-001 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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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Daiichi Sankyo
AstraZeneca
Julphar
US Department of Justice
Accenture
Fish and Richardson
UBS
Chubb

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