Xtandi is a drug owned by Astellas Pharma Us Inc. It is protected by 4 US drug patents filed from 2013 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 11, 2033. Details of Xtandi'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. | |||
| US7709517 | Diarylhydantoin compounds |
Aug, 2027
(2 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). | |||
| US11839689 | Formulations of enzalutamide |
Sep, 2033
(8 years from now) | Active |
| US8183274 | Treatment of hyperproliferative disorders with diarylhydantoin compounds |
Aug, 2026
(1 year, 9 months from now) | Active |
| US9126941 | Treatment of hyperproliferative disorders with diarylhydantoin compounds |
May, 2026
(1 year, 5 months 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 Xtandi's patents.
Latest Legal Activities on Xtandi's Patents
Given below is the list of recent legal activities going on the following patents of Xtandi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 12 Dec, 2023 | US11839689 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Dec, 2023 | US11839689 |
| Recordation of Patent eGrant | 12 Dec, 2023 | US11839689 |
| Recordation of Patent Grant Mailed Critical | 12 Dec, 2023 | US11839689 |
| Mail Patent eGrant Notification | 12 Dec, 2023 | US11839689 |
| Email Notification Critical | 12 Dec, 2023 | US11839689 |
| Email Notification Critical | 23 Nov, 2023 | US11839689 |
| Issue Notification Mailed Critical | 22 Nov, 2023 | US11839689 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Nov, 2023 | US8183274 (Litigated) |
| Application Is Considered Ready for Issue Critical | 09 Nov, 2023 | US11839689 |
FDA has granted several exclusivities to Xtandi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xtandi, 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 Xtandi.
Exclusivity Information
Xtandi holds 5 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Xtandi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 31, 2017 |
| New Indication(I-693) | Sep 10, 2017 |
| New Indication(I-786) | Jul 13, 2021 |
| New Indication(I-808) | Dec 16, 2022 |
| New Indication(I-926) | Nov 17, 2026 |
Several oppositions have been filed on Xtandi's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xtandi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xtandi patents.
Xtandi's Oppositions Filed in EPO
Xtandi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 18, 2012, by Fickert, Stefan. This opposition was filed on patent number EP06748863A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11184401A | Dec, 2015 | Generics (U.K.) Limited | Revoked |
| EP06748863A | Oct, 2012 | Fickert, Stefan | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Xtandi 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 Xtandi's family patents as well as insights into ongoing legal events on those patents.
Xtandi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xtandi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 11, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xtandi Generic API suppliers:
Enzalutamide is the generic name for the brand Xtandi. 3 different companies have already filed for the generic of Xtandi, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xtandi's generic
How can I launch a generic of Xtandi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xtandi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xtandi'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 Xtandi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg | 31 Aug, 2016 | 3 | 14 May, 2021 | 13 Aug, 2027 | Deferred |
| 40 mg and 80 mg | 31 Mar, 2021 | 1 | 13 Aug, 2027 |
About Xtandi
Xtandi is a drug owned by Astellas Pharma Us Inc. It is used for treating non-metastatic castration-sensitive prostate cancer patients with biochemical recurrence at high risk for metastasis. Xtandi uses Enzalutamide as an active ingredient. Xtandi was launched by Astellas in 2020.
Approval Date:
Xtandi was approved by FDA for market use on 04 August, 2020.
Active Ingredient:
Xtandi uses Enzalutamide as the active ingredient. Check out other Drugs and Companies using Enzalutamide ingredient
Treatment:
Xtandi is used for treating non-metastatic castration-sensitive prostate cancer patients with biochemical recurrence at high risk for metastasis.
Dosage:
Xtandi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 80MG | TABLET | Prescription | ORAL |
| 40MG | TABLET | Prescription | ORAL |