Challenge oral anticoagulants! First batch of eliquis imitated drugs approved by FDA

Recently, FDA approved micro Labs Limited and mylan's apixaban generic, indications are: (1) for patients with nonvalvular atrial fibrillation, to reduce the risk of stroke and systemic embolism; (2) for patients undergoing hip or knee replacement, to prevent deep vein thrombosis (DVT, which may lead to pulmonary embolism [PE]; (3) for the treatment of DVT and PE, and to reduce the risk of recurrence of DVT and PE after initial treatment It is worth mentioning that this is also the first FDA approved generic drug for Pfizer / BMS anticoagulant eliquis (apixaban) FDA approval does not mean that the generic drugs will be available in the near future, but it does mean that the low-cost competition for eliquis is ready Pfizer and BMS have been actively responding to the challenge of apixaban generic drugs and defending patent protection BMS said that in the United States, apixaban's compound patent will expire in February 2023, but subsequent authorized patents extended the protection to 2031 Although this point is facing the challenge of imitators in court Eliquis is one of the best-selling drugs in the world In 2018, eliquis brought us $3.4 billion to Pfizer and US $6.4 billion to BMS It is also the second best-selling drug of BMS after tumor immunotherapy opdivo Eliquis sales will increase by $1.08 billion in 2020 from 2019, according to a recent report released by evaluate pharma According to a forecast report released by global data in November this year, the global sales of eliquis will reach US $18.7 billion in 2025, making it the second best-selling drug in the world after keysruda "These approvals mark the first generic approval for direct oral anticoagulants (doac)," said Janet Woodcock, director of the FDA's Center for drug evaluation and research At present, other DOAC on the market also include Bayer / Johnson's Xarelto (Shaaban), the first three Communist Party's Lixiana/Savaysa (Shaaban), and Blyngju G John's Pradaxa (dabigatran) Different from biological generic drugs, the impact of chemical generic drugs on brand drugs can be said to be fatal According to previous data, after the chemical generic drugs are launched, the sales of brand drugs will fall precipitously, and the sales in the first year will easily lose more than half Therefore, if the first batch of apixaban generic drugs are successfully listed, it will undoubtedly seriously affect the sales of eliquis Reference source: FDA clear first genetics of Pfizer / BMS' anticoagulant eliquis