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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Julphar
Colorcon
Express Scripts
US Army
Merck
Federal Trade Commission
Fish and Richardson
Covington

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022362

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NDA 022362 describes WELCHOL, which is a drug marketed by Daiichi Sankyo and is included in three NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 022362
Tradename:WELCHOL
Applicant:Daiichi Sankyo
Ingredient:colesevelam hydrochloride
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 022362
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 022362
Suppliers and Packaging for NDA: 022362
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362 NDA Daiichi Sankyo Inc. 65597-902 N 65597-902-30
WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362 NDA Daiichi Sankyo Inc. 65597-903 N 65597-903-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength1.875GM/PACKET
Approval Date:Oct 2, 2009TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 17, 2022Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength3.75GM/PACKET
Approval Date:Oct 2, 2009TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 17, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022362

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ➤ 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:

QuintilesIMS
Teva
Mallinckrodt
Healthtrust
Julphar
Farmers Insurance
McKinsey
Medtronic
Boehringer Ingelheim

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