This method of use patent covers the company’s Brisdelle (paroxetine) capsules, 7.5mg, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes.
The patent, listed recently in the US Food and Drug Administration (FDA)’s Orange Book, provides additional protection until April 2029, six years beyond the last to expire of the other listed Brisdelle patents.
Brisdelle is the first and only non-hormonal treatment specifically studied and FDA-approved for moderate to severe VMS associated with menopause.
Although it has the same ingredient as the antidepressant paroxetine, Brisdelle is a lower dose (7.5mg) that is not approved to treat depression or any other psychiatric condition. The method of use patent covers the use of paroxetine at this lower dose in treating moderate to severe VMS associated with menopause as a novel approach.