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VYVANSE Drug Profile

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

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

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Four suppliers are listed for this compound. There are five 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 list4

Pharmacology for Tradename: VYVANSE

Clinical Trials for: VYVANSE

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;ORAL021977-005Dec 10, 2007RXNo7,223,735<disabled>Y <disabled>
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-006Dec 10, 2007RXNo7,723,305<disabled>Y <disabled>
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-001Feb 23, 2007RXNo7,671,030<disabled>Y <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

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
8,106,016Compounds and compositions for prevention of overdose of oxycodone<disabled in preview>
7,375,083Pharmaceutical compositions for prevention of overdose or abuse<disabled in preview>
7,427,600Active agent delivery systems and methods for protecting and administering active agents<disabled in preview>
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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
Canada2603873<disabled in preview>
Australia2003217676<disabled in preview>
Japan2007500242<disabled in preview>
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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<disabled>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
2013000079Germany<disabled>PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; NATIONAL REGISTRATION NO/DATE: 86155-86157.00.00 20130318; FIRST REGISTRATION: GB PL 08081/0050-2 20140201
2013 00043Denmark<disabled>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
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