The Food and Drug Administration has granted Mayne Pharma and Mithra Pharmaceuticals approval for Haloette (etonogestrel and ethinyl estradiol) vaginal hormonal contraceptive ring.
Haloette contraceptive is a generic of Organon’s Nuvaring, a combined hormonal contraceptive flexible ring with etonogestrel and ethinyl estradiol that is indicated for the prevention of pregnancy.
Mayne Pharma said it anticipates the commercial launch of Haloettte ring by early 2023.
Nuvaring brand generic sales were approximately $580 million for the 12 months ending June 2022, according to IQVIA.
Under the terms of the long-term license and supply agreement, Mayne Pharma will pay Mithra Pharmaceuticals 6 million euro as a result of receiving FDA approval and 1.6 million euro upon commercial launch in the United States. Mithra will manufacture Haloette at its contract development and manufacturing organization facility in Belgium.
“We are very pleased to announce the approval of Haloette in the U.S. and look forward to bringing this drug-device generic to market,” Mayne Pharma’s CEO Scott Richards said.
“Mayne Pharma is proudly committed to providing women with more affordable and accessible contraceptive choices. After the approval of Nextstellis oral contraceptive in the U.S. and Australia, this marks the third regulatory product approval we have received with Mithra as our development partner,” he said.
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“This important milestone highlights Mithra’s world class drug development and manufacturing capabilities to develop a complex drug-device pharmaceutical,” said CEO Leon Van Rompay. “ We are thrilled to manufacture Haloette ring at our Mithra CDMO and to support the launch of this affordable contraceptive alternative in the U.S., the world’s largest pharmaceutical market.”