Details for New Drug Application (NDA): 215401
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NDA 215401 describes XELSTRYM, which is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the XELSTRYM profile page.
The generic ingredient in XELSTRYM is dextroamphetamine. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextroamphetamine profile page.
The generic ingredient in XELSTRYM is dextroamphetamine. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextroamphetamine profile page.
Summary for 215401
| Tradename: | XELSTRYM |
| Applicant: | Noven Pharms Inc |
| Ingredient: | dextroamphetamine |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215401
Generic Entry Date for 215401*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SYSTEM;TRANSDERMAL |
*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: 215401
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 215401
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401 | NDA | Noven Therapeutics, LLC | 68968-0205 | 68968-0205-3 | 30 POUCH in 1 CARTON (68968-0205-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0205-1) |
| XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401 | NDA | Noven Therapeutics, LLC | 68968-0210 | 68968-0210-3 | 30 POUCH in 1 CARTON (68968-0210-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0210-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 4.5MG/9HR | ||||
| Approval Date: | Mar 22, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 11,559,501 | Patent Expiration: | Jan 6, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,591,941 | Patent Expiration: | Oct 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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