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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208510

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NDA 208510 describes VYVANSE, which is a drug marketed by Shire Development and Shire Dev Llc and is included in two NDAs. It is available from one supplier. There are eighteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VYVANSE profile page.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for 208510
Tradename:VYVANSE
Applicant:Shire Dev Llc
Ingredient:lisdexamfetamine dimesylate
Patents:17
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208510
Generic Entry Date for 208510*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, CHEWABLE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208510
Medical Subject Heading (MeSH) Categories for 208510
Suppliers and Packaging for NDA: 208510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510 NDA Shire LLC 59417-115 59417-115-01 100 TABLET, CHEWABLE in 1 BOTTLE (59417-115-01)
VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510 NDA Shire LLC 59417-116 59417-116-01 100 TABLET, CHEWABLE in 1 BOTTLE (59417-116-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Jan 28, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 30, 2018
Regulatory Exclusivity Use:MODERATE TO SEVERE BINGE EATING DISORDER (BED)
Regulatory Exclusivity Expiration:Oct 14, 2019
Regulatory Exclusivity Use:PROVIDES FOR DATA SUPPORTING THE SAFETY AND EFFECTIVENESS FOR THE MAINTENANCE TREATMENT OF MODERATE TO SEVERE BINGE EATING DISORDER (BED)
Patent:➤ Try a Free TrialPatent Expiration:Feb 24, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

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