Shilpa Medicare Limited has received initial authorization from the European Medicine Agency (EMA) for its Rivaroxaban Orodispersible Films, marking a significant milestone in the company's European expansion strategy. The product represents a generic version of Bayer AG's Xarelto, offering the same therapeutic benefits in a more patient-friendly formulation.
Novel Formulation Addresses Patient Needs
The approved orodispersible film represents the only Rivaroxaban formulation available in oral dissolving film format, designed specifically to enhance patient comfort. This innovation particularly benefits geriatric patients who may experience difficulty swallowing traditional tablet formulations. The product maintains bioequivalence to the reference product Xarelto, ensuring comparable therapeutic efficacy.
Rivaroxaban Orodispersible Films functions as an anticoagulant medicine that prevents blood clotting by inhibiting factor Xa, a key component in the coagulation cascade. The medication is indicated for treating deep vein thrombosis and pulmonary embolism, preventing their recurrence in adults, and preventing atherothrombotic events including heart attack, stroke, and death from heart disease.
Market Opportunity and Regulatory Pathway
The approval positions Shilpa Medicare to compete in Europe's substantial oral Rivaroxaban market, valued at approximately $2.5 billion. The company submitted its application through the EMA's Centralized Procedure as a hybrid application, leveraging the established safety and efficacy profile of the reference product while demonstrating bioequivalence of its novel formulation.
Manufacturing Excellence and Regulatory Standing
The approval stems from Shilpa Medicare's specialized manufacturing facility, Unit VI, located in Dabaspet, Bengaluru, Karnataka. This facility maintains regulatory approvals from multiple international agencies, including the USFDA, European authorities, and MHRA UK, demonstrating its compliance with stringent global manufacturing standards.
This represents the third approval of a prescription oral mouth dissolving film product from the Bengaluru facility in European markets. The facility specializes in manufacturing, packaging, labeling, and testing of specialized finished dosage forms, including oral dispersible/dissolving films and transdermal patches.
The approval strengthens Shilpa Medicare's position in the European pharmaceutical market and validates the company's strategy of developing patient-centric formulations of established therapeutic agents. The orodispersible film technology addresses a significant unmet need in anticoagulant therapy, particularly for patients who struggle with conventional solid dosage forms.
