- New patent extends protection for NEXTSTELLIS® (ESTELLE®) until 2036
- Mayne Pharma has a 20-year exclusive license and supply agreement in the US and Australia for NEXTSTELLIS®
Liege, Belgium, 07 November 2023 – 07:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces today that it has been granted an additional patent for NEXTSTELLIS® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) in the United States.
Granted by the United States Patent and Trademark Office, the new patent will provide NEXTSTELLIS® with oral-dosage-unit protection in the US market until 2036. The patent is a continuation of U.S. Patent No. 11,147,771, covers the composition of NEXTSTELLIS® and was listed in the Orange Book1 on Friday, 3 November 2023.
NEXTSTELLIS® is the first and only contraceptive pill featuring the new estrogen E4, in combination with the well-established progestin drospirenone. E4 is a native and tissue-selective estrogen with distinct effects on breast tissues and the liver. Notably, E4 is naturally produced by the human fetus during pregnancy. The E4 in NEXTSTELLIS® is produced from a plant source.
Mithra’s commercialization partner, Mayne Pharma Group Limited (ASX: MYX), holds the license and supply agreement for NEXTSTELLIS®/ESTELLE® in the United States since 2021.
David Horn Solomon, CEO of Mithra: “We are excited to have been granted this additional patent coverage for ESTELLE® under the trademark NEXTSTELLIS®, an oral contraceptive with a novel estrogen, in the United States. The patent will allow us to further realize its potential in the US market over the coming years and to make a significant difference to the lives of millions of women. Furthermore, the extension of the patent protection could help us achieve an additional 7 years of peak sales opportunities in the US. E4 was the first new estrogen to be introduced in the United States in over 50 years, and we believe it will continue to contribute to redefining women’s health there.”
1 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations List (fda.gov)