Alembic Pharmaceuticals has recently received FDA approval for their generic version of Pradaxa, known as Dabigatran Etexilate Capsules, aimed at reducing the risk of stroke and systemic embolism. This approval covers the 75 mg and 150 mg strengths, with a potential approval for the 110 mg capsules in the pipeline.
FDA Approval:
Alembic has achieved FDA approval for their Dabigatran Etexilate Capsules, designed to lower the risk of stroke and systemic embolism in specific situations, serving as a generic alternative to Boehringer Ingelheim's Pradaxa.
Market Values:
Recent IQVIA data suggests that the combined market value of the 75 mg and 150 mg Dabigatran Etexilate Capsules amounts to approximately $179 million for the year ending in March 2024. Conversely, the 110 mg capsules have a market value of roughly $5 million for the same period.
Indications:
The Dabigatran Etexilate Capsules are meant for lowering the risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients. Furthermore, they are utilized for the management and prevention of deep venous thrombosis and the recurrence of pulmonary embolism in adult patients.
In summary, Alembic's FDA nod for their generic Pradaxa signifies a noteworthy advancement in providing more economical options for individuals in need of anticoagulant therapy. The introduction of these generic capsules offers patients access to cost-efficient yet equally potent alternatives for managing their cardiovascular well-being.