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Last Updated: February 7, 2023

Details for New Drug Application (NDA): 021977


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NDA 021977 describes VYVANSE, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for 021977
Tradename:VYVANSE
Applicant:Takeda Pharms Usa
Ingredient:lisdexamfetamine dimesylate
Patents:18
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021977
Generic Entry Date for 021977*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021977
Medical Subject Heading (MeSH) Categories for 021977
Suppliers and Packaging for NDA: 021977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977 NDA Takeda Pharmaceuticals America, Inc. 59417-101 59417-101-10 100 CAPSULE in 1 BOTTLE (59417-101-10)
VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977 NDA Takeda Pharmaceuticals America, Inc. 59417-102 59417-102-10 100 CAPSULE in 1 BOTTLE (59417-102-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Feb 23, 2007TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Aug 24, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:Aug 24, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:Aug 24, 2023Product Flag?Substance Flag?Delist Request?Y

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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 verification 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.