Adalvo strengthens its specialty generics portfolio with the dossier readiness of Tofacitinib XR (11mg).
Backed by a ready-to-register EU CTD dossier, the extended-release (XR) formulation expands Adalvo’s offering and ensures broader treatment options.
This difficult-to-develop formulation uses an alternative approach to achieve the target release kinetics, while the optimized manufacturing process ensures high productivity at production scale.
DCP submission is planned for May 2025, supporting a streamlined approval pathway across key markets, with launches set to follow as market exclusivity expires.
Developed in collaboration with a strategic partner, the dossier is supported by a strong IP strategy to facilitate market entry.
Adalvo is targeting an addressable global market of approximately $1.9 billion (IQVIA), positioning itself among the key players in this segment.
Tofacitinib 11 mg XR, developed based on the reference brand Xeljanz, is a Janus kinase (JAK) inhibitor indicated for rheumatoid arthritis and psoriatic arthritis in combination with methotrexate. It is also approved for the treatment of adult patients with ankylosing spondylitis, offering targeted relief for inflammatory conditions.
By expanding its portfolio to include both immediate-release and extended-release formulations, Adalvo continues to provide high-value solutions for its global partners.
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