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Last Updated: November 5, 2024

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.
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
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:RXDosage:SYSTEM;TRANSDERMALStrength4.5MG/9HR
Approval Date:Mar 22, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 22, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jan 6, 2042Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?

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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.