In addition, based on recent communications from the USPTO, a third ANNOVERA patent (U.S. Patent No. 10,780,047) is scheduled to be issued on 9/22/2020. These Orange Book eligible patents, which provide patent protection through 2039, cover ANNOVERA and its use for the labeled indication of preventing pregnancy in females of reproductive potential.
Before the issuance of the first Orange Book listable patent for ANNOVERA, the product was protected by FDA regulatory exclusivity through 2023 as a new chemical entity. These additional patents, which cover different aspects of ANNOVERA, provide independent layers of patent protection.
ANNOVERA is a critical component of the company’s drive towards EBITDA breakeven in 2021.