Enzalutamide Patent Expiration
Enzalutamide is Used for treating non-metastatic castration-sensitive prostate cancer patients with biochemical recurrence at high risk for metastasis. It was first introduced by Astellas Pharma Us Inc
Enzalutamide Patents
Given below is the list of patents protecting Enzalutamide, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Xtandi | US12161628 | Combination therapy | Feb 23, 2037 | Astellas |
| Xtandi | US11839689 | Formulations of enzalutamide | Sep 11, 2033 | Astellas |
| Xtandi | US7709517 | Diarylhydantoin compounds | Aug 13, 2027 | Astellas |
| Xtandi | US8183274 | Treatment of hyperproliferative disorders with diarylhydantoin compounds | Aug 24, 2026 | Astellas |
| Xtandi | US9126941 | Treatment of hyperproliferative disorders with diarylhydantoin compounds | May 15, 2026 | Astellas |
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 Enzalutamide's patents.
Latest Legal Activities on Enzalutamide's Patents
Given below is the list recent legal activities going on the following patents of Enzalutamide.
| 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 |
Enzalutamide's Family Patents
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Enzalutamide Generic API Manufacturers
Several generic applications have been filed for Enzalutamide. The first generic version for Enzalutamide was by Actavis Laboratories Fl Inc and was approved on May 14, 2021. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Sep 26, 2024.
Given below is the list of companies who have filed for Enzalutamide generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS LABS FL INC
Actavis Laboratories Fl Inc has filed for 1 generic for Enzalutamide. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule | Discontinued | ORAL | N/A | May 14, 2021 |
2. APOTEX
Apotex Inc has filed for 1 generic for Enzalutamide. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule | Discontinued | ORAL | N/A | Apr 22, 2022 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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3. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Enzalutamide. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule | Discontinued | ORAL | N/A | Sep 26, 2024 |