Details for New Drug Application (NDA): 215401

✉ Email this page to a colleague

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

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?

Expired US Patents for NDA 215401

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022	8,591,941	⤷ Get Started Free
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-002	Mar 22, 2022	8,632,802	⤷ Get Started Free
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022	9,034,370	⤷ Get Started Free
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022	8,632,802	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.