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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 Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 022362

Anticholesteremic Agents

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:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	1.875GM/PACKET
Approval Date:	Oct 2, 2009	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Oct 17, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	3.75GM/PACKET
Approval Date:	Oct 2, 2009	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Oct 17, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022362

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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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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.