Adalvo announces that it will submit its DCP application for Semaglutide (generic for Ozempic®) in February 2026, aligned with the expiry of data exclusivity. The filing will cover the complete range of strengths - 0.25mg, 0.5mg (1.34mg/ml), 0.5mg (0.68mg/ml), 1mg, and the 2mg high-dose.
The 2mg strength is already ramping up globally, capturing more than 30% of the US market. With this addition, Adalvo ensures its partners gain access to the entire range of clinically relevant Semaglutide strengths from Day-1, supporting patient choice and treatment continuity.
Semaglutide, a GLP-1 receptor agonist, has been acknowledged as a significant advancement in recent therapeutic developments, demonstrating established efficacy in improving glycemic control and supporting weight management in adults with type 2 diabetes.
According to IQVIA, Ozempic® achieved global sales of more than $18 billion in 2024, with a 3Y CAGR exceeding 42%, reflecting rapid uptake and sustained worldwide demand.
Adalvo’s dossier is already prepared and has been submitted and approved in several markets worldwide, with commercial supply already underway in selected territories subject to IP. This strong foundation supports a timely EU submission and reinforces Adalvo’s ability to deliver both scale and speed in high-barrier peptide development.
This milestone further highlights Adalvo’s leading position in peptides within the B2B space, complementing its broad diabetes portfolio spanning small molecules, peptide-based therapies, oral and injectable formulations, and both short- and long-acting treatment options.
At Adalvo, there are no half-measures, we are always on target. By ensuring regulatory clarity and launch readiness, we deliver early access to the most commercially relevant assets in today’s healthcare landscape.
For licensing or partnership opportunities within Adalvo’s diabetes portfolio, contact the team today.