Strides Pharma gets FDA nod for Mycophenolate Mofetil, targets $145m market

Strides Pharma Science Limited has announced a significant win as its Singapore-based wholly owned subsidiary, Strides Pharma Global Pte. Limited, has received United States Food & Drug Administration (FDA) approval for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. The product is bioequivalent and therapeutically equivalent to CellCept for Oral Suspension by Roche Palo Alto, LLC.

This FDA approval significantly enhances Strides Pharma’s existing Mycophenolate Mofetil portfolio. The Mycophenolate Mofetil for Oral Suspension alone has a market size of around $41 million per IQVIA, with the entire range of Mycophenolate Mofetil products offering a cumulative market opportunity of approximately $145 million.

Strides Pharma will manufacture the newly approved product at their Bengaluru facility. This addition to the portfolio solidifies Strides Pharma’s position as a market leader in the Mycophenolate Mofetil space. It further augments the company’s robust pipeline of 280 cumulative ANDA (Abbreviated New Drug Application) filings with USFDA. Of these, over 260 ANDAs have already gained approval. The company aims to launch about 60 new products in the US over the next three years.

Mycophenolate Mofetil for Oral Suspension is classified as an immunosuppressant medication. It is commonly used post-transplant in conjunction with other medicines to deter the body from rejecting a newly transplanted organ such as a kidney, heart, or liver. The drug works by suppressing the body’s immune response to ensure it accepts the new organ.

With this new approval, Strides Pharma not only extends its Mycophenolate Mofetil range but also strengthens its position in the US pharmaceutical market, aiming to tap into significant market opportunities.