When does enhertu patent end?

What happens when the Enhertu patent expires?

Enhertu, also known as fam-trastuzumab deruxtecan-nxki, is a targeted therapy developed by AstraZeneca in collaboration with Daiichi Sankyo[1]. It was approved by the FDA in 2020 for the treatment of certain types of breast cancer and lung cancer. Enhertu works by targeting cancer cells that have an overexpression of the HER2 protein, which can lead to aggressive cancer growth.

How long does the Enhertu patent protect its exclusive marketing rights?

The Enhertu patent was granted in July 2019, and its current patent expiration date is not publicly available. However, according to DrugPatentWatch.com [2], the Enhertu patent expiration date is expected to be around February 2038, assuming the patent is not challenged or invalidated.

Can biosimilars enter the market before the patent expires?

The FDA has introduced a pathway for the development of biosimilars, which are biologic medicines that are similar to already approved biologic medicines. However, for a biosimilar to be approved, it must show that it has the same mechanism of action and comparable efficacy and safety to the reference product (in this case, Enhertu). Biosimilars of Enhertu are still in development and have not yet been approved by the FDA.

What will happen after the Enhertu patent expires?

After the patent expires, other companies can develop and market generic or biosimilar versions of Enhertu. This can lead to increased competition and potentially lower prices for the medicine. However, AstraZeneca and Daiichi Sankyo may still have exclusivity for certain indications or patient populations, depending on the terms of any license agreements they have in place.

Sources

[1] AstraZeneca and Daiichi Sankyo. (2020). Enhertu (Fam-trastuzumab Deruxtecan-nxki).

[2] DrugPatentWatch.com. (n.d.). Enhertu (Fam-trastuzumab Deruxtecan-nxki) Patent Expiration Date.