Welcome to “A to Z: Drugs in Highlight
This series is designed to delve into the intricate realm of pharmaceutical drugs. As the world of pharmaceuticals continues to evolve with new discoveries and emerging challenges, we aim to shed light on the diverse array of medications available today, ranging from blockbuster medications to those that may not be as familiar. Whether you’re a healthcare professional, a student, or simply someone with a curious mind, “A to Z: Drugs in Highlight” promises to be an enlightening and engaging series.
X is for XTANDI®
XTANDI® (from Pfizer and Astellas Pharma) is used to treat men with prostate cancer.
How it works:
Prostate cancer is a type of cancer that develops in the prostate, a small gland in the male reproductive system responsible for producing fluid that nourishes and transports sperm. Prostate cancer begins when cells in the prostate gland start to grow uncontrollably, typically due to mutations in the DNA of these cells. These genetic changes cause the cells to divide and grow more rapidly than normal cells, leading to the formation of a tumour.
The active substance in XTANDI® is enzalutamide. Enzalutamide treats prostate cancer by blocking the action of the male hormone testosterone and other male hormones known as androgens. It works by inhibiting the receptors to which these hormones attach. Since prostate cancer cells rely on these hormones to survive and grow, enzalutamide effectively slows down the progression of the cancer by blocking their effects.
Market impact:
XTANDI® is approved for marketing in the United States (approved by the FDA in August 2012) and in Europe (approved by the EMA in June 2023).
According to Pfizer’s 2024 Annual Review, XTANDI® generated USD 2.039 billion in revenue in 2024. The reported figure primarily reflects alliance revenues and royalty revenues.
Patent protection:
There are patent rights protecting various aspects of XTANDI® in the United States and Europe. For example, in Europe, EP1893196B2 relates to a compound having the formula
or a pharmaceutically acceptable salt thereof. EP1893196 is due to expire in 2026. Supplementary Protection Certificates (SPCs) based on EP1893196 extend protection for “enzalutamide or a pharmaceutically acceptable salt thereof” until June 2028.
Astellas Pharma recently defended EP1893196 against generic manufacturers at the UK High Court. The UK High Court upheld EP1893196 and the SPC in its entirety, dismissing the nullity action brought by Accord, Sandoz and Teva (see [2024] EQHC 2524 (Pat)). This decision by the UK High Court prohibits the generic drug manufacturers from prematurely launching their generic version of XTANDI® in the UK market.
Patent support from Secerna
Our team has a wealth of experience gained from working with world leaders in the chemistry and pharmaceutical disciplines encompassing new chemical entities, materials science, agricultural chemistry, chemical processes and formulation technology. We have also worked extensively in the medical device materials and carbon nanotechnology sectors.
For intellectual property advice relating to your next project, please get in touch. Our team will be happy to assist. Contact us here.
