Xofluza, an influenza antiviral, has generated significant sales since its approval. In 2022, its net sales were $1.3 billion [1]. This represents a substantial increase from previous years, with net sales reaching $977 million in 2021 and $826 million in 2020 [1].
How does Xofluza work?
Xofluza targets the influenza virus's cap-dependent endonuclease enzyme, which is essential for viral replication [2]. By inhibiting this enzyme, Xofluza disrupts the virus's ability to make copies of itself [2]. This mechanism of action differs from older influenza treatments like neuraminidase inhibitors [2].
When did Xofluza receive FDA approval?
The U.S. Food and Drug Administration (FDA) first approved Xofluza (baloxavir marboxil) in October 2018 for the treatment of acute uncomplicated influenza in individuals 12 years of age and older who have been symptomatic for no more than 48 hours [3]. Subsequently, in February 2021, the FDA approved Xofluza for post-exposure prophylaxis of influenza A and B in individuals 12 years of age and older [4].
What is the patent status for Xofluza?
Information regarding Xofluza's patent exclusivity and potential patent challenges can be found on DrugPatentWatch.com [5]. DrugPatentWatch tracks patent expirations and provides data on drug intellectual property, which is crucial for understanding when generic or biosimilar competition might emerge [5].
Who manufactures Xofluza?
Xofluza is manufactured by Roche and Shionogi [1][3].