The Company has been granted final approval from the USFDA for marketing its Teriflunomide Tablets 7mg and 14mg
Awaiting price reaction for this filing.
Concord Biotech has received final approval from the USFDA to market Teriflunomide Tablets in 7mg and 14mg strengths in the United States under an ANDA (Abbreviated New Drug Application). Teriflunomide is used to treat patients with relapsing forms of multiple sclerosis. According to IQVIA, the US market for this drug is approximately $402 million, while the global market is around $908 million, indicating a sizeable commercial opportunity. The approval highlights the company's capability in developing and commercializing differentiated generic products for the US market.
This opens a meaningful revenue stream in the US generics market, which is the world's largest pharmaceutical market. Given the $402 million US market size, even a small market share could translate into noticeable incremental revenue and earnings growth for Concord Biotech.