Shilpa Medicare receives initial European authorization for Rivaroxaban Orodispersible Films
This authorization opens entry into a substantial European market valued at USD 2.5 billion for oral Rivaroxaban formulations. The unique ODF form differentiates Shilpa Medicare's product, potentially capturing significant market share and driving revenue growth from a key facility.
The company has received initial authorization for a generic version of a significant drug in the European market. The product offers a unique formulation (Orodispersible Films) which provides a competitive advantage and addresses patient comfort, indicating strong market potential.
Shilpa Medicare Limited announced on 22nd September 2025, that it has received initial authorization from the European Medicine Agency (EMA), recommending the grant of final Marketing Authorization for its medicinal product, Rivaroxaban 10 mg, 15 mg, and 20 mg Orodispersible Films. * This application was submitted as a hybrid application via the EMA’s Centralized Procedure and is a generic version of Bayer AG’s innovator product, Xarelto®, which is available as oral tablets. * Shilpa’s product is bioequivalent to Xarelto® and is the only Rivaroxaban available in an Orodispersible Film (ODF) form, offering enhanced patient comfort, particularly for geriatric patients. * The medicine is an anticoagulant used to treat deep vein thrombosis and pulmonary embolism, prevent their recurrence in adults, and prevent atherothrombotic events. * The total European market for oral Rivaroxaban formulations is estimated at USD 2.5 billion (approximately ₹20,850 crore). * The approval was granted for the Company’s finished dosage form manufacturing facility at Dabaspet, Bengaluru, Karnataka, which is also approved by USFDA, Europe, and MHRA UK. * This marks the third approval from this facility for a prescription oral mouth dissolving film product in the European markets.
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Shilpa Medicare Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it high impact, which is the band that most often changes something.
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