1. Generics Bulletin
  2. >>Products

Hyloris Announces Approval Of Condylox First Generic

US FDA Authorizes Podofilox Product With 180-Day CGT Exclusivity

 
• By Chloe Kent

Hyloris has received US approval for its generic podofilox gel, previously referred to as HY-016.

FDA building.
Approval marks Hyloris' second in the US this year after Maxigesic IV • Source: Shutterstock

Belgian biopharma Hyloris Pharmaceuticals SA has announced that its development partner Padagis LLC has received final approval from the US Food and Drug Administration for the first generic rival to AbbVie’s Condylox (podofilox) Gel 0.5% . Podofilox gel is an antimycotic drug for the topical treatment of external genital and perianal warts.

Key takeaways:

  • Hyloris has announced the US approval of its generic podofilox gel, with commercialization by partner Padagis due to start this month

  • The product has been granted a 180-day competitive generic therapy exclusivity

  • This is the second US launch from Hyloris this year following the introduction of Maxigesic IV in

The product was previously referred to by Hyloris as HY-016 and is one of three high-barrier generic products in its portfolio,

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Products

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 
• By Urtė Fultinavičiūtė

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By Dave Wallace

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Tetris Deal Falls Into Place For UK’s Aspire

 
• By Dave Wallace

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By Dave Wallace

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

More from Generics Bulletin

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By Dave Wallace

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.