China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Swiss giant Novartis’ Gilenya (fingolimod). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc.
Drug Background and Market Status
Fingolimod, a sphingosine-1-phosphate receptor (S1PR) agonist, prevents the outflow of lymphocytes from the lymph nodes, thereby reducing the recurrence of multiple sclerosis (MS) and lesions. The drug was first approved in the US in September 2010 as a first-line MS therapy to reduce recurrence rates. It received market approval in China in July 2019 and was included in the National Reimbursement Drug List (NRDL) in 2020. Currently, no generic version is commercially available.
Patent and Commercialization Details
Fingolimod is under patent protection in the US, where only the originator product is on the market. According to Huahai’s announcement, the company will commercialize its generic version in accordance with an agreement reached with Novartis. As of April 6, 2022, Huahai has obtained 74 ANDA approvals from the US FDA, making it the leading Chinese company in terms of US generic approvals.
Patent Expiration and Future Outlook
Fineline Info & Tech‘s Drug data tracking system indicates that Novartis’ patents for pharmaceutical combinations and medicinal uses of chemicals containing fingolimod will expire on April 6, 2024, in China. Beijing Continent Pharmaceuticals Co., Ltd has filed a Category 4.2 patent declaration for the drug.-Fineline Info & Tech
