DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022362
» See Plans and Pricing
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 Action | Bile-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: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 1.875GM/PACKET | ||||
Approval Date: | Oct 2, 2009 | TE: | RLD: | Yes | |||||
Patent: | Start 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: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | Oct 17, 2022 | Product 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 |
Complete Access Available with Subscription