UK-based specialty pharma company Diurnal Group said that the US Patent and Trademark Office (USPTO) has granted a second US patent for Chronocort (modified release hydrocortisone).
US 10,166,194, entitled “Hydrocortisone Controlled Release Formulation”, is a patent claiming a method of treatment for adrenal dysfunction, including the diseases congenital adrenal hyperplasia (CAH) and adrenal insufficiency (AI) that delivers hydrocortisone in accordance with a circadian rhythm.
The patent provides in-market protection until 2033 and is in addition to the already granted pharmaceutical composition of matter patent US 9,750,704, which provides in-market protection until 2034.
This patent expands the Company’s strong exclusivity position in the US, where Chronocort has already received Orphan Drug Designation for the treatment of both CAH and AI from the US Food and Drug Administration (FDA), which provides the potential for seven years of market exclusivity awarded on approval.
The US is expected to be a major territory for sales of Chronocort, with CAH and AI collectively estimated to affect 140,000 adult patients and have an addressable market of approximately $1bn.
Diurnal CEO Martin Whitaker said: “This second Chronocortpatent provides additional in-market protection in the US, which remains a key target market for Diurnal, in addition to the potential for market exclusivity provided by the award of Orphan Drug Designation for both CAH and AI.
“With patents now extending protection in the US for both Chronocort and our paediatric product Alkindito 2034, we are confident that, if approved, these products will enjoy a long period of exclusivity in the US market and provide the potential for lifelong treatment of patients with CAH and AI.”
Source: Company Press Release