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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cipla
McKesson
US Army
Covington
Chubb
Cantor Fitzgerald
Dow
Deloitte
Healthtrust

Generated: January 22, 2018

DrugPatentWatch Database Preview

VYVANSE Drug Profile

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When do Vyvanse patents expire, and when can generic versions of Vyvanse launch?

Vyvanse is a drug marketed by Shire Development and Shire Dev Llc 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-seven patent family members in twenty-six countries.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for VYVANSE
Drug patent expirations by year for VYVANSE
Pharmacology for VYVANSE
Medical Subject Heading (MeSH) Categories for VYVANSE

US Patents and Regulatory Information for VYVANSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-005 Dec 10, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-005 Jan 28, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-001 Feb 23, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-004 Dec 10, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-001 Jan 28, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-002 Feb 23, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for VYVANSE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg ➤ Subscribe 2/23/2011

Non-Orange Book US Patents for 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
8,133,881 Carbohydrate conjugates to prevent abuse of controlled substances ➤ Subscribe
7,622,441 Sustained release pharmaceutical compounds to prevent abuse of controlled substances ➤ Subscribe
6,716,452 Active agent delivery systems and methods for protecting and administering active agents ➤ Subscribe
7,375,082 Abuse-resistant hydrocodone compounds ➤ Subscribe
7,169,752 Compounds and compositions for prevention of overdose of oxycodone ➤ Subscribe
7,427,600 Active agent delivery systems and methods for protecting and administering active agents ➤ Subscribe
8,343,927 Pharmaceutical compositions for prevention of overdose or abuse ➤ Subscribe
7,338,939 Abuse-resistant hydrocodone compounds ➤ Subscribe
7,018,654 Pharmaceutical composition containing an active agent in an amino acid copolymer structure ➤ Subscribe
7,060,708 Active agent delivery systems and methods for protecting and administering active agents ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for VYVANSE

Supplementary Protection Certificates for VYVANSE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013000079 Germany ➤ Subscribe PRODUCT 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
13/038 Ireland ➤ Subscribe PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY A MESYLATE SALT; NAT REGISTRATION NO/DATE: PA0689/006/001 PA0689/006/002
2013 00043 Denmark ➤ Subscribe PRODUCT 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
90058-4 Sweden ➤ Subscribe PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Deloitte
Covington
Federal Trade Commission
UBS
Novartis
Harvard Business School
Healthtrust
McKinsey
Express Scripts

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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