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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Argus Health
Cerilliant
Farmers Insurance
Boehringer Ingelheim
Deloitte
Cipla
Merck
Chinese Patent Office
Dow

Generated: August 20, 2017

DrugPatentWatch Database Preview

VYVANSE Drug Profile

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What is the patent landscape for Vyvanse, and when can generic versions of Vyvanse launch?

Vyvanse is a drug marketed by Shire Dev Llc and Shire Development and is included in two NDAs. There are eighteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Four suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

Summary for Tradename: VYVANSE

Patents:18
Applicants:2
NDAs:2
Suppliers / Packagers: see list4
Bulk Api Vendors: see list12
Clinical Trials: see list53
Patent Applications: see list30
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VYVANSE at DailyMed

Pharmacology for Tradename: VYVANSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Dev Llc
VYVANSE
lisdexamfetamine dimesylate
TABLET, CHEWABLE;ORAL208510-004Jan 28, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-003Feb 23, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Shire Dev Llc
VYVANSE
lisdexamfetamine dimesylate
TABLET, CHEWABLE;ORAL208510-006Jan 28, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-003Feb 23, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Shire Dev Llc
VYVANSE
lisdexamfetamine dimesylate
TABLET, CHEWABLE;ORAL208510-003Jan 28, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
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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

Non-Orange Book Patents for Tradename: VYVANSE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,338,939Abuse-resistant hydrocodone compounds► Subscribe
6,716,452 Active agent delivery systems and methods for protecting and administering active agents► Subscribe
8,394,813Active agent delivery systems and methods for protecting and administering active agents► Subscribe
7,375,082Abuse-resistant hydrocodone compounds► Subscribe
8,106,016Compounds and compositions for prevention of overdose of oxycodone► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VYVANSE

Country Document Number Estimated Expiration
China1925865► Subscribe
European Patent Office1865980► Subscribe
Spain2371462► Subscribe
European Patent Office2080511► Subscribe
Canada2527646► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VYVANSE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90058-4Sweden► SubscribePRODUCT NAME: LISDEXAMFETAMIN VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT, SAERSKILT ETT MESYLATSALT; NAT. REG. NO/DATE: 47382 20130722; FIRST REG.: GB PL 08081/0050-52 20130201
2013000079Germany► SubscribePRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201
2013 00043Denmark► SubscribePRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER ET MESYLAT SALT; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Army
Fish and Richardson
Farmers Insurance
Deloitte
Harvard Business School
Covington
UBS
QuintilesIMS
Citi
US Department of Justice

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.

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