Who makes enfuvirtide [Fuzeon]?

enfuvirtide [Fuzeon] is developed by Hoffmann-La Roche.

What development phase is enfuvirtide [Fuzeon] in?

enfuvirtide [Fuzeon] is FDA-approved (marketed).

Last reviewed 2026-05-14 · How we verify

enfuvirtide [Fuzeon]

Hoffmann-La Roche · FDA-approved active Small molecule Quality 2/100

Enfuvirtide [Fuzeon], marketed by Hoffmann-La Roche, is a unique antiretroviral drug with a distinct mechanism of action, currently holding a niche position in the HIV treatment market. Its key strength lies in being the only FDA-approved fusion inhibitor, offering a critical option for patients resistant to other antiretrovirals. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Generic name	enfuvirtide [Fuzeon]
Sponsor	Hoffmann-La Roche
Modality	Small molecule
Phase	FDA-approved

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

enfuvirtide [Fuzeon] CI brief — competitive landscape report
enfuvirtide [Fuzeon] updates RSS · CI watch RSS
Hoffmann-La Roche portfolio CI