FDA Approves Viatris Once-Weekly Contraceptive Patch

Why This Matters: This anticipated approval has been one to watch for, for one of Contract Pharma’s Top 20 companies.

The U.S. FDA approved Viatris’ Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system), a low-dose estrogen patch. Gwyn Lo, a combined hormonal contraceptive (CHC), demonstrated efficacy in women of childbearing potential (body mass index below 30 kg/m²).

The patch is non-invasive, reversible, and offers a low-estrogen-dose option for women who seek once-weekly administration. The dose breaks down to norelgestromin 220 mcg/day, and ethinyl estradiol 20 mcg/day.

In Contract Pharma’s upcoming Top 20 Pharma and Biopharma Companies issue, Viatris (No. 20) anticipated a norelgestromin approval in 2026.

A Menu of Contraceptive Options

The company says a need continues, particularly in the United States, for contraceptive options tailored to individual needs and preferences.

Statistics as of 2019 showed 41.6% of pregnancies in the U.S. are unintended. As such, the issue is significant to public health across the country.

More recently, a 2023 U.S. Centers for Disease Control and Prevention survey revealed trends in contraceptive method selection. The survey showed 18.1% of women had changed or stopped a method in the previous 12 months. Among those, 42.8% reported they did not like the method they had been using.

Building on Viatris’ Legacy

Viatris Chief R&D Officer Philippe Martin said the approval builds on the company’s legacy in women’s health. It also draws from Viatris’ prior expertise in transdermal drug delivery systems.

“We are pleased that the approved label for this new patch reflects the strength of our clinical program,” Martin said.

Martin also added, though efficacy only satisfied up to a BMI of less than 30, the FDA approval has no BMI-based limitation.

Viatris expects Gwyn Lo to be commercially available by the end of 2026.