The deal resolves the litigation relating to Sandoz’s generic fulvestrant product, for which it is seeking approval from the US Food and Drug Administration (FDA).
The US Faslodex patents are scheduled to expire in January 2021, with paediatric exclusivity continuing until July 2021.
The US District Court for New Jersey recently entered a consent judgement filed by both gthe firms, including an injunction preventing Sandoz from launching a generic fulvestrant product until 25 March 2019, or earlier in several circumstances.
Faslodex is a prescription medicine used to treat hormone receptor-positive metastatic breast cancer in women who have gone through menopause whose disease has spread following treatment with antiestrogen medicine.
Earlier this year, the FDA approved a new indication expanding the use of Faslodex to include use in combination with palbociclib.
The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.
Faslodex should not be received if a patient had an allergic reaction to any of its ingredients.
Symptoms of an allergic reaction to Faslodex could include itching, swelling of face, lips, tongue, or throat, or trouble breathing.