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Last Updated: April 17, 2024

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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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Drug patent expirations by year for XELSTRYM
Drug Prices for XELSTRYM

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XELSTRYM
Generic Entry Date for XELSTRYM*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
NDA:
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

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

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

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
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
>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.

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
European Patent Office 2934496 COMPOSITIONS ET PROCÉDÉS POUR L'ADMINISTRATION TRANSDERMIQUE D'AMPHÉTAMINE (COMPOSITIONS AND METHODS FOR TRANSDERMAL DELIVERY OF AMPHETAMINE) ⤷  Try a Trial
European Patent Office 4274555 COMPOSITIONS TRANSDERMIQUES D'AMPHÉTAMINE À FAIBLES TAUX DE CARBAMATE (TRANSDERMAL AMPHETAMINE COMPOSITIONS WITH LOW LEVELS OF CARBAMATE) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2014066585 ⤷  Try a Trial
Argentina 098878 COMPOSICIONES Y MÉTODOS PARA ADMINISTRACIÓN TRANSDÉRMICA DE ANFETAMINA ⤷  Try a Trial
European Patent Office 3086783 COMPOSITIONS ET PROCÉDÉS POUR L'ADMINISTRATION TRANSDERMIQUE D'AMPHÉTAMINE (COMPOSITIONS AND METHODS FOR TRANSDERMAL DELIVERY OF AMPHETAMINE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.