Adalvo has initiated pilot bioequivalence (BE) studies for its generic Letermovir tablets — a significant milestone in bringing a generic version of this complex, first-in-class antiviral to market. Filings are planned across multiple markets outside the EU* in 2026.
Letermovir is indicated for the prevention of cytomegalovirus (CMV) infection in adults undergoing Haematopoietic Stem Cell Transplants (HSCT) or kidney transplants.
Unlike older antivirals that treat active infections, Letermovir prevents CMV from becoming active in the first place. By keeping the virus dormant, Letermovir avoids the bone marrow toxicity (neutropenia) and kidney toxicity (nephrotoxicity) associated with older antivirals.
IQVIA figures show global sales of Letermovir exceeded $1.1 billion in 2025. That’s a growth of over 80% in just two years, reflecting both the clinical value and commercial opportunity.
With strong in-house capabilities and an extensive global supplier network, Adalvo is well positioned to overcome the technical and API sourcing challenges of this high-barrier molecule, and offer Day-1 opportunities to partners.
For licensing opportunities, or to see our full portfolio of antiviral therapies, contact one of the team today.
*Excluding markets where regulatory data protection for Letermovir is still in force, such as the EU.