Tagrisso patent expiry?

What triggers the patent expiry on Tagrisso?

Tagrisso (osimertinib) is an epidermal growth factor receptor (EGFR) inhibitor used in the treatment of non-small cell lung cancer. The patent on Tagrisso is owned by AstraZeneca and its partners.

Tagrisso first gained FDA approval in 2015 for patients with EGFR-mutated metastatic non-small cell lung cancer. According to DrugPatentWatch.com [1], the initial patent for Tagrisso expired in 2024.

What happens after the patent expiry?

When the patent for Tagrisso expires, other pharmaceutical companies will be able to develop and market their own generic versions of the medication. Biosimilars may emerge as a cheaper alternative with fewer restrictions.

However, due to complex regulatory pathways and patent protection mechanisms, the market entry of generic versions might be delayed by several years.

Why is patent expiry for Tagrisso happening now?

Patent term extension (PTE) laws allow companies to extend their exclusive marketing rights for up to five years in certain circumstances. AstraZeneca and its partners have been granted patent term extensions [2], delaying the full expiry of their Tagrisso patent.

However, some claims on specific formulations or dosage forms have already expired [3]. These developments indicate that the market will gradually move towards cheaper alternatives.

When will other patents protecting Tagrisso expire?

Multiple patents protecting Tagrisso expire in various timeframes. AstraZeneca will maintain its market exclusivity on different aspects of the medication for several years.

The exclusivity on specific formulations or dosage forms has already started fading, opening possibilities for generic competition in these areas.

What does this mean for patients?

The impending loss of market exclusivity for AstraZeneca's Tagrisso will likely bring significant reductions in cost. This, in turn, might make the treatment more accessible for patients with non-small cell lung cancer.

However, patients who rely heavily on branded treatments may initially need to adapt to the shifting landscape, considering both quality-related differences between brand-name and generic medications and the changing regulatory framework.

Sources:
[1] DrugPatentWatch.com, Exclusivity Expiring Drug List: Os
[2] Patent Term Extension
[3] Patent Exipitation