Xospata is a drug owned by Astellas Pharma Us Inc. It is protected by 8 US drug patents filed from 2018 to 2024 out of which none have expired yet. Xospata's patents have been open to challenges since 28 November, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2036. Details of Xospata's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8969336 | Diamino heterocyclic carboxamide compound |
Nov, 2032
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11938132 | Stable pharmaceutical composition for oral administration |
Jul, 2036
(11 years from now) | Active |
| US11938133 | Stable pharmaceutical composition for oral administration |
Jul, 2036
(11 years from now) | Active |
| US11944620 | Stable pharmaceutical composition for oral administration |
Jul, 2036
(11 years from now) | Active |
| US11938130 | Stable pharmaceutical composition for oral administration |
Jul, 2036
(11 years from now) | Active |
| US10786500 | Stable pharmaceutical composition for oral administration |
Jul, 2036
(11 years from now) | Active |
| US11938131 | Stable pharmaceutical composition for oral administration |
Jul, 2036
(11 years from now) | Active |
| US9487491 | Diamino heterocyclic carboxamide compound |
Jul, 2030
(5 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 Xospata's patents.
Latest Legal Activities on Xospata's Patents
Given below is the list of recent legal activities going on the following patents of Xospata.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Apr, 2024 | US9487491 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Apr, 2024 | US11944620 |
| Patent eGrant Notification | 02 Apr, 2024 | US11944620 |
| Recordation of Patent eGrant | 02 Apr, 2024 | US11944620 |
| Recordation of Patent Grant Mailed Critical | 02 Apr, 2024 | US11944620 |
| Mail Patent eGrant Notification | 02 Apr, 2024 | US11944620 |
| Email Notification Critical | 02 Apr, 2024 | US11944620 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Mar, 2024 | US10786500 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Mar, 2024 | US11938130 |
| Email Notification Critical | 26 Mar, 2024 | US11938130 |
FDA has granted several exclusivities to Xospata. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xospata, 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 Xospata.
Exclusivity Information
Xospata holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Xospata's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 28, 2023 |
| Orphan Drug Exclusivity(ODE-222) | Nov 28, 2025 |
US patents provide insights into the exclusivity only within the United States, but Xospata 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 Xospata's family patents as well as insights into ongoing legal events on those patents.
Xospata's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xospata's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xospata Generics:
There are no approved generic versions for Xospata as of now.
How can I launch a generic of Xospata before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xospata's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xospata's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Xospata -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg | 28 Nov, 2022 | 1 | 01 Jul, 2036 |
About Xospata
Xospata is a drug owned by Astellas Pharma Us Inc. It is used for treating acute myeloid leukemia. Xospata uses Gilteritinib Fumarate as an active ingredient. Xospata was launched by Astellas in 2018.
Approval Date:
Xospata was approved by FDA for market use on 28 November, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Xospata is 28 November, 2018, its NCE-1 date is estimated to be 28 November, 2022.
Active Ingredient:
Xospata uses Gilteritinib Fumarate as the active ingredient. Check out other Drugs and Companies using Gilteritinib Fumarate ingredient
Treatment:
Xospata is used for treating acute myeloid leukemia.
Dosage:
Xospata is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | TABLET | Prescription | ORAL |