Monday May 13th 2024


Mithra, a company dedicated to women’s health, announces that it has been granted two additional patents for NEXTSTELLIS® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) in the United States. The U.S. patent numbers are 11,957,694 and 11,964,055.

The patents, which are FDA Orange Book1 listed, provide additional protection to the NEXTSTELLIS® formulation. Both newly listed patents are terminally disclaimed over the previously announced U.S. Patent No. 11,793,760 (listed in October 2023) and will also expire on 17 June 2036.

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.

Graham Dixon, Chief Scientific Officer of Mithra, stated, “We are excited to have been granted additional patent coverage for ESTELLE® under the trademark NEXTSTELLIS®, an oral contraceptive with a novel estrogen, in the United States. The new patents complement our previous patent (11,793,760) by offering different or additional scopes of claims to enforce our patent rights. We currently have several additional patent applications pending, demonstrating our ongoing commitment to patent-protect our breakthrough innovations.

1 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations List (