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Profile for Tradename: VYVANSE

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Vyvanse is a drug marketed by Shire Development and is included in one NDA. It is available from three suppliers. There are eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-one patent family members in twenty-five countries.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

Summary for Tradename: VYVANSE

Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list18
2013 Sales:$1,743,115,000

Pharmacology for Tradename: VYVANSE

Clinical Trials for: VYVANSE

Effect of Vyvanse on Driving in Young Adults With ADHD
Status: Completed Condition: Attention Deficit/Hyperactivity Disorder(ADHD)

Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Status: Completed Condition: Attention Deficit Hyperactivity Disorder; Sleep

A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Status: Completed Condition: Healthy

Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
Status: Terminated Condition: Attention Deficit Hyperactivity Disorder; Glucose Intolerance; Obesity

Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
Status: Completed Condition: Healthy Volunteers

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression
Status: Terminated Condition: Bipolar Depression

Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults
Status: Completed Condition: Attention Deficit Hyperactivity Disorder (ADHD)

The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading
Status: Completed Condition: Attention Deficit/Hyperactivity Disorder

Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Status: Completed Condition: Cocaine Dependence

A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
Status: Completed Condition: ADHD

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-002Feb 23, 2007RXNo7,687,467<disabled>Y<disabled>
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-006Dec 10, 2007RXNo<disabled><disabled>
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-001Feb 23, 2007RXNo<disabled><disabled>
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-001Feb 23, 2007RXNo7,687,467<disabled>Y<disabled>
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-006Dec 10, 2007RXNo7,662,788<disabled><disabled>
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Paragraph IV activity for: VYVANSE

Drugname Dosage Strength RLD Submissiondate
lisdexamfetamine dimesylateCapsules20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mgVyvanse2/23/2011

International Patent Family for Tradename: VYVANSE

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)03072047Sep 04, 2003
Australia2004204804Jul 29, 2004
South Korea20040095228Nov 12, 2004
European Patent Office1531844Aug 20, 2014
Australia8659901May 06, 2002
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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