Mayne Pharma launches another generic oral contraceptive

Rhea-AI Summary

Mayne Pharma Group Limited (ASX: MYX) announced the launch of a generic version of ORTHO-CEPT® (desogestrel and ethinyl estradiol) in the US. This is their fourth oral contraceptive launch this year, following LOESTRIN® 24 FE, ORTHO CYCLEN®, and ORTHO TRI-CYCLEN®. Combined, these products represent a US market value of approximately US$315 million as of January 2021. The company also has four women’s health products pending FDA approval, including NEXTSTELLIS™, potentially introducing a new estrogen to the market for the first time in 50 years.

Positive

• Launch of generic ORTHO-CEPT expands the Women's Health portfolio.
• Fourth oral contraceptive launched in 2021, signaling strong product development.
• Access to a market valued at approximately US$315 million for the four products.
• Pending FDA approval for innovative products like NEXTSTELLIS™.

Negative

• None.

ADELAIDE, Australia, March 4, 2021 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the commercial launch of a generic version of ORTHO-CEPT® (desogestrel and ethinyl estradiol 0.15 mg / 0.03 mg) tablets to customers in the US.

This is the fourth oral contraceptive launched this calendar year after launching generic versions of LOESTRIN® 24 FE, ORTHO CYCLEN® and ORTHO TRI-CYCLEN®. According to IQVIA, the annual US market sales for the four products were approximately US$315 million in the twelve months ending January 2021^[1].

Mayne Pharma's CEO Scott Richards said, "We are very pleased to expand our Women's Health portfolio which now covers ~80% of Obstetrician/Gynaecologist oral contraceptive prescription volumes[1] and includes 24 marketed branded generic contraceptives. Mayne Pharma is committed to helping meet the needs of women in the US by providing cost effective, high-quality and novel contraceptive options. The four new products launched this year were sourced from the strategic partnership with Novast Laboratories."

"In addition, Mayne Pharma has four women's health pipeline products pending at the FDA including the novel combined oral contraceptive NEXTSTELLIS™ (E4/DRSP) and a generic version of NUVARING®. NEXTSTELLIS which has a FDA target action date in April contains a new estrogen called estetrol or E4 in combination with a progestin, drospirenone. If approved, E4 will be the first new estrogen introduced in the US for contraceptive use in approximately 50 years."

About Mayne Pharma

Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals, offering patients better and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.

Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that continue to be marketed around the world.

Mayne Pharma has two facilities based in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds.

LOESTRIN® 24 FE, NEXTSTELLIS™, NUVARING®, ORTHO-CEPT®, ORTHO CYCLEN® and ORTHO TRI-CYCLEN® are registered trademarks of third parties.

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^_[1] IQVIA, MAT Sales and NSP Units for brand and generic equivalents, January 2021

 

View original content:http://www.prnewswire.com/news-releases/mayne-pharma-launches-another-generic-oral-contraceptive-301241071.html

SOURCE Mayne Pharma

FAQ

What did Mayne Pharma announce on March 4, 2021, regarding its products?

Mayne Pharma announced the launch of a generic version of ORTHO-CEPT® in the US, marking it as the fourth oral contraceptive launch of the year.

What is the market value of the contraceptive products launched by Mayne Pharma?

The combined market value of the four contraceptive products launched this year is approximately US$315 million.

What are the upcoming products pending FDA approval from Mayne Pharma?

Mayne Pharma has four women's health products pending FDA approval, including NEXTSTELLIS™ and a generic version of NUVARING®.

What is NEXTSTELLIS™ and when is its FDA target action date?

NEXTSTELLIS™ is a novel combined oral contraceptive containing a new estrogen called estetrol and has a target action date at the FDA in April.