Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208524

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NDA 208524 describes BELVIQ XR, which is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BELVIQ XR profile page.

The generic ingredient in BELVIQ XR is lorcaserin hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lorcaserin hydrochloride profile page.
Summary for 208524
Tradename:BELVIQ XR
Applicant:Eisai Inc
Ingredient:lorcaserin hydrochloride
Patents:16
Formulation / Manufacturing:see details
Pharmacology for NDA: 208524
Suppliers and Packaging for NDA: 208524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BELVIQ XR lorcaserin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208524 NDA Eisai Inc. 62856-535 62856-535-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62856-535-30)
Paragraph IV (Patent) Challenges for 208524
Tradename Dosage Ingredient NDA Submissiondate
BELVIQ XR TABLET, EXTENDED RELEASE;ORAL lorcaserin hydrochloride 208524 2016-12-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jul 15, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 31, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 10, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR CHRONIC WEIGHT MANAGEMENT BY CONTROLLING WEIGHT GAIN
Patent:  Start TrialPatent Expiration:Apr 10, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR CHRONIC WEIGHT MANAGEMENT BY DECREASING FOOD INTAKE

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