FDA clears first generics of Pfizer/BMS’ anticoagulant Eliquis

The FDA has approved the first two generics of Pfizer and Bristol-Myers Squibb’s blockbuster anticoagulant drug Eliquis, from Micro Labs and Mylan.

FDA approval doesn’t necessarily mean that the generics will be made available anytime soon, as Pfizer and BMS are claiming patent protection for several more years, but the stage is now set for lower-cost competition for their big-selling drug.

The two companies have been actively challenging attempts by generic drugmakers to bring copycat version of Eliquis (apixaban) to market and defend the drug, which made $6.4bn for BMS last year – it’s second biggest product after cancer immunotherapy Opdivo (nivolumab) – and added $3.4bn to Pfizer’s top line.

BMS says the composition of matter patent covering apixaban in the US expires in February 2023 and subsequent awards have extended that protection until 2031, although that is being challenged in the courts.

The FDA has approved Micro Labs and Mylan’s generics to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF), one of Eliquis’ key indications.

BMS and Pfizer’s drug is also used to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip or knee replacement surgery, as a treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE after initial therapy.

“These approvals mark the first generic approvals of a direct oral anticoagulant,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).

Other directly-acting or ‘novel orally acting anticoagulants’ (NOACs) include Bayer/Johnson & Johnson's Xarelto (rivaroxaban) and Daiichi Sankyo's Lixiana/Savaysa – which like Eliquis are Factor Xa inhibitors – and Boehringer Ingelheim’s thrombin inhibitor Pradaxa (dabigatran)

Unlike older anticoagulants like warfarin, “direct oral anticoagulants…do not require repeated blood testing,” said Woodcock.

It is thought that up to 6.1 million people in the US have AF, so the commercial opportunity for generics is expected to be substantial, and the availability of the first generic NOAC could impact the sales of all drugs in the class.

Last year, Aurobindo was given tentative FDA approval for its apixaban generic, ahead of the resolution of ongoing patent litigation.