Xelstrym is a drug owned by Noven Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2022 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 06, 2042. Details of Xelstrym's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8632802 | Device for transdermal administration of drugs including acrylic polymers |
Oct, 2025
(1 year, 2 months from now) | Active |
| US9034370 | Device for transdermal administration of drugs including acrylic polymers |
Oct, 2025
(1 year, 2 months from now) | Active |
| US8591941 | Transdermal drug delivery device including an occlusive backing |
Oct, 2025
(1 year, 2 months from now) | Active |
| US9474722 | Compositions and methods for transdermal delivery of amphetamine |
Oct, 2033
(9 years from now) | Active |
| US9456993 | Compositions and methods for transdermal delivery of amphetamine |
Oct, 2033
(9 years from now) | Active |
| US11559501 | Transdermal amphetamine compositions with low levels of carbamate |
Jan, 2042
(17 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Xelstrym's patents.
Latest Legal Activities on Xelstrym's Patents
Given below is the list of recent legal activities going on the following patents of Xelstrym.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed | 24 Jan, 2023 | US11559501 |
| Patent Issue Date Used in PTA Calculation | 24 Jan, 2023 | US11559501 |
| Email Notification | 05 Jan, 2023 | US11559501 |
| Issue Notification Mailed | 04 Jan, 2023 | US11559501 |
| Dispatch to FDC | 23 Dec, 2022 | US11559501 |
| Application Is Considered Ready for Issue | 23 Dec, 2022 | US11559501 |
| Response to Reasons for Allowance | 16 Dec, 2022 | US11559501 |
| Issue Fee Payment Verified | 16 Dec, 2022 | US11559501 |
| Issue Fee Payment Received | 16 Dec, 2022 | US11559501 |
| Electronic Review | 22 Nov, 2022 | US11559501 |
FDA has granted several exclusivities to Xelstrym. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xelstrym, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xelstrym.
Exclusivity Information
Xelstrym holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Xelstrym's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 22, 2025 |
US patents provide insights into the exclusivity only within the United States, but Xelstrym is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xelstrym's family patents as well as insights into ongoing legal events on those patents.
Xelstrym's family patents
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Generic Launch
Generic Release Date:
Xelstrym's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 06, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xelstrym Generics:
There are no approved generic versions for Xelstrym as of now.
About Xelstrym
Xelstrym is a drug owned by Noven Pharmaceuticals Inc. It is used for treating Attention Deficit Hyperactivity Disorder (ADHD) with a transdermal amphetamine composition. Xelstrym uses Dextroamphetamine as an active ingredient. Xelstrym was launched by Noven Pharms Inc in 2022.
Market Authorisation Date:
Xelstrym was approved by FDA for market use on 22 March, 2022.
Active Ingredient:
Xelstrym uses Dextroamphetamine as the active ingredient. Check out other Drugs and Companies using Dextroamphetamine ingredient
Treatment:
Xelstrym is used for treating Attention Deficit Hyperactivity Disorder (ADHD) with a transdermal amphetamine composition.
Dosage:
Xelstrym is available in system form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 13.5MG/9HR | SYSTEM | Prescription | TRANSDERMAL |
| 9MG/9HR | SYSTEM | Prescription | TRANSDERMAL |
| 4.5MG/9HR | SYSTEM | Prescription | TRANSDERMAL |
| 18MG/9HR | SYSTEM | Prescription | TRANSDERMAL |