Finerenone patent expiration?

When does the finerenone patent expire?

Finerenone, also known as BAY 94-8862, is a selective, nonsteroidal mineralocorticoid receptor antagonist developed by Bayer for the treatment of primary aldosteronism and chronic kidney disease [1]. The drug was first approved in Europe and the United States for patients with autosomal dominant polycystic kidney disease (ADPKD) in 2021 and 2022, respectively.

How long does the exclusivity period last?

The finerenone patent is granted until 2038, according to the patents database DrugPatentWatch.com [2]. The company has secured several patents for the use of finerenone in various conditions, with an estimated expiration date for the primary patent in 2038.

What are the implications for biosimilar entry?

As the primary patent expires, biosimilar drug manufacturers will need to await the end of the exclusivity period. Following this, they will be able to file for approval and potentially bring a cheaper alternative on the market. This could lead to increased competition in the market, benefiting patients with autosomal dominant polycystic kidney disease (ADPKD) and those with other relevant indications.

Comparison to other treatments

Finerenone's patent expiration will also be closely watched by the market for its comparison to other treatments, such as Siponimod (Novartis' multiple sclerosis medication, with its patent set to expire in 2039 according to DrugPatentWatch.com) [3] and other competitors in the space.

Sources:

[1] https://www.bayer.com/en/mediaserver/finerenone-as-primary-aldosteronism-treatment-02.05.2022.pdf
[2] https://www.drugpatentwatch.com/finerenone/US
[3] https://www.drugpatentwatch.com/Spionimod/US