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Details for New Drug Application (NDA): 021977
NDA 021977 describes VYVANSE, which is a drug marketed by Shire Development and Shire Dev Llc 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. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for 021977
| Tradename: | VYVANSE |
| Applicant: | Shire Development |
| Ingredient: | lisdexamfetamine dimesylate |
| Patents: | 18 |
| Formulation / Manufacturing: | see details |
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
| Physiological Effect | Central Nervous System Stimulation |
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 | Shire LLC | 59417-101 | 59417-101-10 | 100 CAPSULE in 1 BOTTLE (59417-101-10) |
| VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977 | NDA | Shire LLC | 59417-102 | 59417-102-10 | 100 CAPSULE in 1 BOTTLE (59417-102-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Feb 23, 2007 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 30, 2018 | ||||||||
| Regulatory Exclusivity Use: | MODERATE TO SEVERE BINGE EATING DISORDER (BED) | ||||||||
| Regulatory Exclusivity Expiration: | Oct 14, 2019 | ||||||||
| Regulatory Exclusivity Use: | PROVIDES FOR DATA SUPPORTING THE SAFETY AND EFFECTIVENESS FOR THE MAINTENANCE TREATMENT OF MODERATE TO SEVERE BINGE EATING DISORDER (BED) | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Feb 24, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) | ||||||||
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