Lotus Pharmaceuticals and Alvogen US today announced that Celgene filed a suit in the U.S. District Court of New Jersey. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Lotus’ ANDA for up to 30 months from the date the plaintiffs received notice of Lotus' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Lotus filed an Abbreviated New Drug Application (ANDA) with the United Stated Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of Celgene’s Revlimid® (Lenalidomide). Lotus’ ANDA included a Paragraph IV certification with respect to the patents listed in the FDA “Orange Book”. Lotus’ ANDA product is Lenalidomide 2.5, 5, 10, 15, 20 and 25mg, indicated for the treatment of several hematological malignancies including multiple myeloma.
Andrew Lin, Chairman of Lotus, commented, “We spent the past 2 years re-prioritizing our pipeline, aiming at the highest opportunities with more differentiated products. Lenalidomide is undoubtedly a significant product for Lotus, and both the Lotus and Alvogen team are proud to be among the early wave of filers in the US. Together, we are stronger on R&D, legal and regulatory fronts of the Paragraph IV challenge.”
Andrew further pointed out that Lenalidomide will be a global product for the Company while US market remains most attractive. The Company has also completed filings in Europe and multiple countries in Asia. He said, “We believe this is also a great news for patients, who will finally have access to a more affordable treatment. I would like to thank both the Lotus and Alvogen teams for their valuable efforts in submitting this filing. Moreover, during the past 12 months, we have witnessed notable progress in our pipeline as several key products are now closer to commercialization.”
For the 12 months ending December 31, 2016, Revlimid® had total U.S. sales of approximately $4.4 billion, according to the reported sales of Celgene. Statista projected Lenalidomide to be the world’s top cancer drug by 2020.