AstraZeneca and Sandoz resolve Faslodex patent litigation

AstraZeneca announced today that it has entered into an agreement with Sandoz to resolve patent litigation between the two companies.

As reported by  Reuters, the companies have agreed to resolve the dispute centring on Sandoz’s generic version of Faslodex (fulvestrant).

Fulvestrant, a hormonal therapy drug used to treat breast cancer, became the centre of the  dispute after Sandoz filed an Abbreviated New Drug Application with the US Food and Drug Administration (FDA).

Sandoz had applied for FDA approval before the expiration of AstraZenca’s US patent numbers 6,774,122; 7,456,160; 8,329,680; and 8,466,139.

The patents are due to expire in January 2021, but have a pediatric exclusivity stretching until July 2021.

AstraZeneca sued Sandoz at the US District Court for the District of New Jersey in 2014.