Farxiga patent expiry date?

When Does Farxiga Patent Expire?

[1] The Farxiga patent, which is owned by AstraZeneca, has a complex patent expiration timeline. In the United States, the original New Drug Application (NDA) for Farxiga was approved in 2013 [DrugPatentWatch.com]. The primary patent, which covers the drug's active ingredient dapagliflozin, is expected to expire in 2025 [1].

However, AstraZeneca has a number of secondary patents that are expected to expire in subsequent years. These patents cover various aspects of Farxiga, including its dosing regimens and formulations. As a result, the exact date when Farxiga will become available as a generic medication is difficult to determine [1].

What's the Impact of Patent Expiration on AstraZeneca's Sales?

AstraZeneca has implemented various strategies to maintain its market share for Farxiga after the primary patent expires. The company has filed additional patent applications that are expected to provide protection for a longer period. Furthermore, AstraZeneca has invested in the development of new formulations and indications for Farxiga, which may help to maintain its market position [1].

Can Biosimilars Enter the Market Before Exclusivity Expires?

The U.S. Food and Drug Administration (FDA) has approved several applications for biosimilar versions of Farxiga, which are expected to be available on the market once the exclusivity period expires. However, the FDA's approval process for biosimilars is separate from the patent expiration timeline [1].

Sources

[1] DrugPatentWatch.com - https://www.drugpatentwatch.com/drugs/farxiga