Lotus Pharmaceutical Co., Ltd. (“Lotus” or “the Company”, Taiwan TWSE ticker: 1795) confirms today that it filed an Abbreviated New Drug Application (“ANDA”) containing a paragraph IV certification with US FDA seeking approval to market a generic version of Rydapt® (midostaurin), which the patents listed in FDA’s Orange Book are owned by Novartis AG (“Novartis”) and Dana-Farber Cancer Institute Inc. (“Dana Farber”). Novartis and Dana Farber filed suit against Lotus in the US seeking to prevent Lotus from commercializing its ANDA product prior to the expiration of the patents in-suit. The lawsuit was initiated under the Hatch-Waxman Act.
Pursuant to the rules under the Hatch-Waxman Act, the patent owners had the right to file suit within 45 days from the date of being notified by Lotus of the paragraph IV certification. Lotus believes that it is among the first applicants to file an ANDA for Rydapt® and that the Company may be eligible for 180 days of exclusivity.
Petar Vazharov, Chief Executive Officer of Lotus, commented: “Further to our previous success on Lenalidomide filing in the US, we are excited to share our first successful NCE-1 ANDA submission and its acceptance for review by the US FDA. Thanks to the combined efforts by portfolio management, research and development, and regulatory affairs teams, we have made another progress for our oncology portfolio into US, the single largest market in the world. With our Site Master Plan moving into the 3rd phase of oncology area upgrade as scheduled, Lotus is ready to provide the most cost-efficient oncology products to the patients around the world, and more importantly, to realize our mission to become a global leader in oral oncology.”
Rydapt® (midostaurin) softgel capsules are indicated for the treatment of several hematological malignancies including acute myeloid leukemia. According to IQVIA data, the total sales of Rydapt® in the US were approximately US$ 91 million for the 12 months ended December 31, 2020. Rydapt® currently does not have any approved generic competitors on the market in the US.