Tagrisso patent expiration?

When Does the Exclusivity for Tagrisso End?

Tagrisso (osimertinib) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) used in the treatment of certain types of non-small cell lung cancer (NSCLC) [1]. The patent for this medication is set to expire in 2027, at which point generic versions of Tagrisso may become available in the US [2].

What Happens After the Patent Expires?

According to the FDA, biosimilar versions of approved biologics like Tagrisso can enter the market after 12 years from the date of the biologic's first approval, or after the expiration of the last patent covering the reference product [3]. In this case, the first approval for Tagrisso was granted in 2015, which gives the manufacturer some additional time.

How Will the Expiration Affect Patients and Payers?

As the Tagrisso patent nears expiration, patients, payers, and manufacturers are watching closely. Generic alternatives to Tagrisso will need to demonstrate comparable efficacy and safety to the market leader to capture share. Additionally, the price competition expected to result from the generic entry could lead to increased access and reduced costs for this critical medication.

Sources:

[1] AstraZeneca. Tagrisso: Highlights of Prescribing Information. https://www.astrazeneca-us.com/our-pipeline/tagrisso (accessed 2023)

[2] DrugPatentWatch.com. Osimertinib Patents - Patent Expire Dates. https://www.drugpatentwatch.com/drug/osimertinib (accessed 2023)

[3] US FDA. Biosimilar Approvals. https://www.fda.gov/drugs/biosimilar-insulin/biosimilar-approvals (accessed 2023)