Adalvo submitted the dossier for Ceftazidime + Avibactam (2 g/0.5 g) powder for solution for infusion on December 31st, 2025.
Based on the reference brands, Zavicefta (EU) and Avycaz (US), the antibiotic combination is indicated for three serious bacterial infections: complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) including pyelonephritis, and Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP).
The niche antibiotic combination product is on a growing sales trajectory. According to IQVIA, global MAT sales reached $535 million in 2023, with a 3-year CAGR of 6%.
As a complex antibiotic therapy, Ceftazidime + Avibactam represents a significant technical accomplishment for Adalvo. Both the active pharmaceutical ingredient (API) and finished dosage form (FDF) are difficult to manufacture, and little competition is expected. Furthermore, Adalvo has secured one of the few API sources on Earth.
The company remains on target for a Day-1 launch in key markets, reaffirming its commitment to providing high-quality, affordable medicines for critical healthcare needs.
To discuss licensing opportunities or to see Adalvo’s full infectiology portfolio, contact a member of the team today.