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Last Updated: January 15, 2021

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 Inc and Daiichi Sankyo and is included in four NDAs. It is available from two suppliers. There are two patents 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. Fifteen 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
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 Ohm Laboratories, Inc. 51660-995 51660-995-30 30 PACKET in 1 CARTON (51660-995-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET
WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362 NDA Daiichi Sankyo Inc. 65597-902 65597-902-30 30 PACKET in 1 CARTON (65597-902-30) > 1 FOR SUSPENSION in 1 PACKET
Paragraph IV (Patent) Challenges for 022362
Tradename Dosage Ingredient NDA Submissiondate
WELCHOL FOR SUSPENSION;ORAL colesevelam hydrochloride 022362 2010-04-09

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength1.875GM/PACKET
Approval Date:Oct 2, 2009TE:RLD:Yes
Patent:  Start 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:ABRLD:Yes
Patent:  Start 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 022362-002 Oct 2, 2009   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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