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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Harvard Business School
Boehringer Ingelheim
US Department of Justice
Federal Trade Commission

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021977

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NDA 021977 describes VYVANSE, which is a drug marketed by Shire Dev Llc and Shire Development and is included in two NDAs. It is available from four suppliers. 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 is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

Summary for NDA: 021977

Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021977

Suppliers and Packaging for NDA: 021977

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lisdexamfetamine dimesylate
CAPSULE;ORAL 021977 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-751 35356-751-30 30 CAPSULE in 1 BOTTLE (35356-751-30)
lisdexamfetamine dimesylate
CAPSULE;ORAL 021977 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-751 35356-751-60 60 CAPSULE in 1 BOTTLE (35356-751-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Feb 23, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 14, 2019
Regulatory Exclusivity Use:
Patent:7,223,735Patent Expiration:Feb 24, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,655,630Patent Expiration:Feb 24, 2023Product Flag?Substance Flag?YDelist Request?

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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
Johnson and Johnson
Farmers Insurance
Harvard Business School

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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