Xtandi enzalutamide market exclusivity timeline?

When Does Xtandi's Exclusivity Expire?

Enzalutamide, marketed as Xtandi, is an oral androgen receptor inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer and metastatic castration-resistant prostate cancer [1]. The drug's market exclusivity has been extended, but a timeline for exclusivity expiration remains crucial for biosimilar entry and competition.

What's the Patent Expiration Date of Xtandi?

According to drugpatentwatch.com, a US patent for xtandi was filed in 2009 (US 8,153,804 B2) with an expiration date of 2027 [2]. However, it is essential to note that a patent expiration date does not necessarily mean the medication will lose exclusivity immediately. Companies can request additional exclusivities and extend the protection period.

How Long Do Additional Exclusivities Extend Xtandi's Exclusivity?

Besides the patent itself, Xtandi holds an Orphan Drug Exclusivity (ODE) granted by the FDA under the Rare Disease Act of 2002 for the treatment of prostate cancer [3]. This exclusivity will extend until September 2028. Xtandi also has an NCE (New Chemical Entity) exclusivity, which typically lasts for 5 years from FDA approval. Xtandi was FDA-approved in 2012, meaning this exclusivity expired in 2017.

What Other Factors May Affect Xtandi's Exclusivity Timeline?

Xtandi's manufacturer, Pfizer and Astellas, may also file for additional exclusivities such as Supplemental New Animal Drug Exclusivity, pediatric exclusivity, or marketing exclusivity in the United States, potentially further extending the exclusivity period [4].

When Will Xtandi Lose Market Exclusivity?

Assuming there are no additional exclusivities granted or approved, Xtandi is likely to lose market exclusivity when the Orphan Drug Exclusivity granted for the treatment of prostate cancer expires in 2028 (the ODE extends the market exclusivity until this date) [3].

Sources:

[1] US FDA. Xtandi. 2022.
[2] drugpatentwatch.com. Xtandi. 2022.
[3] US FDA. Orphan Drug Exclusivity. 2022.
[4] US FDA. Supplemental New Animal Drug Exclusivity. 2022.