XELSTRYM Drug Patent Profile

Which patents cover Xelstrym, and what generic alternatives are available?

Xelstrym is a drug marketed by Noven Pharms Inc and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in XELSTRYM is dextroamphetamine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dextroamphetamine profile page.

DrugPatentWatch^® Generic Entry Outlook for Xelstrym

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 6, 2042. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (dextroamphetamine), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XELSTRYM

US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Patent Applications:	2,311
Drug Prices:	Drug price information for XELSTRYM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELSTRYM
What excipients (inactive ingredients) are in XELSTRYM?	XELSTRYM excipients list
DailyMed Link:	XELSTRYM at DailyMed

See drug prices for XELSTRYM

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XELSTRYM

Constraining patent/regulatory exclusivity:

11,559,501

NDA:

215401

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 XELSTRYM

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for XELSTRYM

XELSTRYM is protected by four US patents.

This potential generic entry date is based on patent 11,559,501.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022		RX	Yes	No	9,456,993		Y
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-002	Mar 22, 2022		RX	Yes	No	9,474,722		Y
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022		RX	Yes	No	9,474,722		Y
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022		RX	Yes	No	11,559,501		Y
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-002	Mar 22, 2022		RX	Yes	No	11,559,501		Y

Expired US Patents for XELSTRYM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-002	Mar 22, 2022	8,632,802
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022	8,591,941
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022	9,034,370
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022	8,591,941
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022	8,632,802

International Patents for XELSTRYM

When does loss-of-exclusivity occur for XELSTRYM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Canada

China

European Patent Office

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XELSTRYM around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	124577
Canada	3203041
China	116997330
European Patent Office	4274555
Taiwan	202241397

DrugChatter Q&A for XELSTRYM

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