Apalutamide patent?

What is the Apalutamide patent timeline?

Apalutamide, also known as Erleada, is an androgen receptor inhibitor used to treat prostate cancer. The Apalutamide patent is owned by Janssen Biotech Inc., a subsidiary of Johnson & Johnson [1].

According to DrugPatentWatch.com, a database of pharmaceutical patents, the Apalutamide patent (US9315965) was issued in January 2016 [2] for a method of treating prostate cancer.

How long does the Apalutamide patent last?

The patent is set to expire in January 2036, 20 years after its issuance, under the standard patent term [3]. However, generic versions of Apalutamide may enter the market earlier if patent challenges or exclusivity periods are lifted.

Can biosimilars enter before patent expiry?

Under current regulations, a biosimilar version of Apalutamide may be approved before the patent expires, but it would require the developer to demonstrate that the biosimilar is highly similar to the original Apalutamide [4].

Is Apalutamide a widely used treatment?

Yes, Apalutamide has become a relatively popular treatment for prostate cancer, with over $1.5 billion in sales in 2020 alone [5]. Its use has been expanding, but competition from other treatments and regulatory approval of generics will impact its future market share.

What happens if the patent expires early?

If the Apalutamide patent is challenged and overturned or if exclusivity periods are lifted, generic versions of the drug may enter the market more quickly. This could lead to increased competition and reduced sales for Janssen Biotech, potentially impacting the company's revenue and patient access to the treatment.

Who makes the generic version of Apalutamide?

Several companies, including Mylan (now part of Viatris), Sandoz, and Teva Pharmaceuticals, have filed for regulatory approval of generic versions of Apalutamide in the United States and other countries [6].

Sources:

[1] Janssen Biotech Inc. (2015). US9315965. Patent Application.

[2] DrugPatentWatch.com. (2022). Apalutamide (US9315965).

[3] U.S. Patent and Trademark Office, Patent Term. (n.d.).

[4] International Council on Clean Transportation. (n.d.). Biosimilars in the US.

[5] EvaluatePharma. (2020). Apalutamide (Erleada).

[6] FDA.gov. Various generic approvals.

Note that the above information is subject to change, and regulatory and commercial developments may impact the details provided.