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XELSTRYM Drug Patent Profile

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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 six patents protecting this drug.

This drug has thirty-three patent family members in twelve countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Xelstrym

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 22, 2025. 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

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Summary for XELSTRYM

International Patents:	33
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Patent Applications:	2,603
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

Drug patent expirations by year for XELSTRYM

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

Generic Entry Date for XELSTRYM^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: NEW PRODUCT 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 six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XELSTRYM is ⤷ Try a Trial.

This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XELSTRYM

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Transdermal drug delivery device including an occlusive backing
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Device for transdermal administration of drugs including acrylic polymers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Compositions and methods for transdermal delivery of amphetamine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE

Compositions and methods for transdermal delivery of amphetamine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting XELSTRYM

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	215401-004	Mar 22, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for XELSTRYM

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

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Country	Patent Number	Title	Estimated Expiration
Canada	2934924	COMPOSITIONS ET PROCEDES POUR L'ADMINISTRATION TRANSDERMIQUE D'AMPHETAMINE (COMPOSITIONS AND METHODS FOR TRANSDERMAL DELIVERY OF AMPHETAMINE)	⤷ Try a Trial
Taiwan	201534310	Compositions and methods for transdermal delivery of amphetamine	⤷ Try a Trial
Taiwan	I632923		⤷ Try a Trial
Argentina	124577	COMPOSICIONES TRANSDÉRMICAS DE ANFETAMINA CON BAJOS NIVELES DE CARBAMATO	⤷ Try a Trial
Mexico	2007004315	DISPOSITIVO PARA SUMINISTRO TRANSDERMICO DE FARMACO QUE INCLUYE UN RESPALDO OCLUSIVO. (TRANSDERMAL DRUG DELIVERY DEVICE INCLUDING AN OCCLUSIVE BACKING.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration