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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Questions you can ask:
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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: | 4,185 |
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 |
![xelstrym drug patent expirations Drug patent expirations by year for xelstrym](/p/graph/s/t/xelstrym-patent-expirations.png)
![Drug Prices for xelstrym](/p/graph/drug-price/xelstrym.png)
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
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 ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Transdermal drug delivery device including an occlusive backing
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Device for transdermal administration of drugs including acrylic polymers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Device for transdermal administration of drugs including acrylic polymers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for transdermal delivery of amphetamine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting xelstrym
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Noven Pharms Inc | XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401-001 | Mar 22, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Noven Pharms Inc | XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401-003 | Mar 22, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Noven Pharms Inc | XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401-004 | Mar 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 |
---|---|---|---|
Spain | 2596809 | ⤷ Sign Up | |
Taiwan | 201427723 | Compositions and methods for transdermal delivery of amphetamine | ⤷ Sign Up |
Peru | 20060491 | DISPOSITIVO TRANSDERMICO DE TRANSMISION DE FARMACO QUE INCLUYE UN REFUERZO OCLUSIVO | ⤷ Sign Up |
Australia | 2014370133 | Compositions and methods for transdermal delivery of amphetamine | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |