Tagrisso patent?

What is the Tagrisso patent expiration timeline?

Tagrisso, also known as osimertinib, is a medication developed by AstraZeneca to treat non-small cell lung cancer (NSCLC) with specific EGFR mutations. The Tagrisso patent is the proprietary protection afforded to this product by AstraZeneca.

When does the Tagrisso patent expire?

The Tagrisso patent expiration timeline is complex and varies depending on the country and region. According to DrugPatentWatch.com, Tagrisso's patent is listed to expire on different dates in various countries: [1]
- In the United States, the Tagrisso patent expiration is expected in 2028, with the earliest expiration on February 28, 2029 [1].
- In the European Union, the patent expiration will occur in 2029, depending on when the patent was first approved in that country [1].

What are the implications of patent expiration?

Upon patent expiration, biosimilars and generic versions of Tagrisso can be developed and marketed, potentially increasing competition and reducing costs for patients. In the United States, generic or biosimilar versions of the medicine can be approved by the FDA up to two years after patent expiration, which could be in 2030 [1].

It's essential to note that generic pharmaceutical companies may begin preparing for market launch years before the patent expiration, often developing biosimilars or generic versions under the Hatch-Waxman Act's Section 355(j)(5)(B)(iv) [2].

The expiration of the Tagrisso patent may lead to reduced prices, increased accessibility, and greater competition in the market, ultimately benefitting patients with non-small cell lung cancer.

References

[1] https://www.drugpatentwatch.com/medicine/1556/osimertinib
[2] https://www.drugpatentwatch.com/article/understanding-the-hatch-waxman-act