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Adalvo Submits DCP for Tofacitinib ER

Business
30 April 2025

Adalvo has submitted the DCP for Tofacitinib 11mg ER, marking a step forward in the expansion of our specialty generics portfolio. 

Designed as an extended-release formulation of the reference brand Xeljanz, Tofacitinib ER is a Janus kinase (JAK) inhibitor indicated for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Tofacitinib ER offers more convenient once-daily dosing, addressing unmet needs in the inflammatory disease treatment landscape. 

Backed by a strong IP strategy, this difficult-to-develop product utilises an alternative approach to achieve the desired release kinetics while ensuring high productivity at commercial scale. 

With global MAT sales of approximately $1.9 billion (IQVIA), Tofacitinib ER represents a strong opportunity across key markets. Launches are expected to follow as market exclusivity expires, ensuring timely access for patients and partners alike. 

Adalvo remains focused on delivering high-quality differentiated therapies to market, positioning itself as a partner of choice in the specialty generics space. 

Get in touch to explore Adalvo’s expanding portfolio.