Aurobindo Pharma, a leading Indian pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for the generic equivalent of Xarelto (Rivaroxaban), a popular anticoagulant drug. The generic version, Rivaroxaban Tablets, will be used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone knee or hip replacement surgery.
Xarelto is a blockbuster drug developed by Johnson & Johnson and is marketed by Bayer. According to Aurobindo Pharma, it is one of the most widely used oral anticoagulant drugs, with over 1.5 million prescriptions filled in the US alone in 2020. However, it is notoriously difficult to manufacture and has been the subject of several patent disputes.
Aurobindo Pharma’s generic version of Xarelto is the first to receive FDA approval and will be available in the US market in the coming weeks. The company claims that its generic version is identical in composition, strength, and dosage form to the branded version, and is therefore substitutable.
The approval is significant for Aurobindo Pharma, which has been aggressively pursuing FDA approvals for generic versions of blockbuster drugs. The company has over 200 ANDA (Abbreviated New Drug Application) filings pending with the FDA, including several for complex products such as Xarelto.
The pricing of Aurobindo Pharma’s generic Xarelto will likely be significantly lower than the branded version, which could potentially disrupt the market dynamics. The branded Xarelto is currently priced at around $120 per 20-mg tablet, while Aurobindo Pharma’s generic version will be priced much lower, around $4-5 per tablet.
The generic approval is also seen as a shot in the arm for India’s pharmaceutical industry, which has been under pressure due to rising competition from China and patent-related issues. Aurobindo Pharma’s success will likely encourage other Indian companies to invest in developing generic versions of complex products, which could help to reduce the country’s dependence on branded drugs.
In conclusion, Aurobindo Pharma’s FDA approval for the generic equivalent of Xarelto is a significant development in the pharmaceutical industry, particularly for the Indian company and the country’s pharma sector as a whole. The generic version is expected to be priced lower than the branded version, which could disrupt the market dynamics and provide patients with a more affordable option.