Initial Authorization for Rivaroxaban Orodispersible Films from Europe
SHILPAMED · price
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Shilpa Medicare has received Initial Authorization from the European Medicine Agency (EMA) for its Rivaroxaban 10mg, 15mg, and 20mg Orodispersible Films (ODF), paving the way for final Marketing Authorization in Europe. The product is a generic version of Bayer's blockbuster anticoagulant Xarelto®, used to treat and prevent blood clots, strokes, and heart attacks. It is the only Rivaroxaban available in oral dissolving film (ODF) form, which improves patient comfort, especially for geriatric patients. The total European market for oral Rivaroxaban formulations is around USD 2.5 billion, representing a significant commercial opportunity. This is the third prescription oral mouth dissolving film approval from Shilpa's Dabaspet (Bengaluru) facility, which is already approved by USFDA, EMA, and MHRA UK.
Positive development for Shilpa Medicare as it gains regulatory entry into a large USD 2.5 billion European market with a differentiated product format (ODF). While final marketing approval and commercialization timelines are still ahead, this strengthens the company's generic and specialty formulation pipeline and signals potential future revenue growth from European markets.