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 in its drug Xtandi on Aug 31, 2012. 3 different companies have introduced drugs containing Enzalutamide.


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 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.

Given below is the list recent legal activities going on the following patents of Enzalutamide.

Event Date Patent/Publication
Patent litigations
Patent eGrant Notification 12 Dec, 2023 US11839689
Patent Issue Date Used in PTA Calculation 12 Dec, 2023 US11839689
Recordation of Patent eGrant 12 Dec, 2023 US11839689
Recordation of Patent Grant Mailed 12 Dec, 2023 US11839689
Mail Patent eGrant Notification 12 Dec, 2023 US11839689
Email Notification 12 Dec, 2023 US11839689
Email Notification 23 Nov, 2023 US11839689
Issue Notification Mailed 22 Nov, 2023 US11839689
Payment of Maintenance Fee, 12th Year, Large Entity 22 Nov, 2023 US8183274(Litigated)
Application Is Considered Ready for Issue 09 Nov, 2023 US11839689



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Enzalutamide Generics

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 Apotex Inc and was approved on Apr 22, 2022.

Given below is the list of companies who have filed for Enzalutamide generic.


1. 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


2. 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