Hyloris obtains FDA OK for generic Condylox

Hyloris Pharmaceuticals SA's partner Padagis has received The Food and Drug Administration’s permission for Podofilox Gel, the first drug product generic to Condylox Gel 0.5%.

For the 12 months period ending December 2022, Condylox Gel 0.5% had a market value of approximately $9 million, per IQVIA. 

The FDA has granted Competitive Generic Therapy exclusivity providing Padagis with a 180 day market exclusivity period during which other generics may not be launched. Commercialization by Padagis will commence this month.

[Read more: Teva debuts generic Denavir]

Stijn Van Rompay, CEO of Hyloris, said, “This is the second product approval of the year in the United States. supported by Hyloris, following our recent success with Maxigesic IV. We are excited to launch, with Padagis, the first generic version of Condylox Gel in the United States. The availability of the generic Condylox Gel reinforces Hyloris' mission to make a meaningful difference in the lives of patients by delivering innovative and accessible pharmaceutical solutions. The company remains focused on expanding its portfolio to address unmet medical needs and contribute to a more sustainable healthcare system.”