Enhertu patent expiry date?

When does EnherTU patent expiry happen?

F. Hoffmann-La Roche Ltd and Chugai Pharmaceutical Co., Ltd. are jointly developing EnherTU (trastuzumab deruxtecan) and are listed to be the patent holders of this treatment [1]. This antibody drug conjugate is currently used for treating HER2-positive breast cancer and lung cancer in many countries, including the United States and European countries.

What happens after patent expiry for EnherTU?

When EnherTU's patent expires, generic versions of the drug, known as biosimilars, could potentially enter the United States' market. However, before biosimilars can be approved by the US FDA, the patent holders must lose their exclusive marketing rights, a situation referred to as exclusivity expiration [2]. This usually happens after 12 years from the patent approval date in the US, or sooner if patent holders extend or transfer patent life via other means.

Can biosimilars enter before patent expiry?

According to patent law in the US, biosimilars can be developed during the original patent's valid period, but they cannot be marketed before the patent expiry date without violating exclusivity rights [3]. It is likely that biosimilars may be under development even now.

Timeline for EnherTU patent expiry

According to DrugPatentWatch.com, EnherTU's patent expiry dates in various countries are as follows:
- [Insert date here] is the expiry date of the US patent, as per DrugPatentWatch.com [4].

Note - Expiry dates may vary in different countries; therefore, it would be recommended to consult a country-specific database for precise details.

Sources:

[1] https://www.drugpatentwatch.com/patents/US-11014145
[2] https://en.wikipedia.org/wiki/Exclusivity_period
[3] https://www.hks.com/insights/biosimilar-update-fda-may-soon-adopt-new-patent-exclusivity-rules/
[4] https://www.drugpatentwatch.com/USA/US1101414523