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FDA approves first Eliquis generic: apixaban

Nicole Roder writer headshot By | January 3, 2020
Medically reviewed by Karen Berger, Pharm.D.

Patients who are at high risk for stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT) will soon have a new generic option for blood thinners. On December 23, the U.S. Food and Drug Administration (FDA) approved two applications for the first generics of Eliquis (apixaban) tablets. 

What is Eliquis?

“Eliquis is a blood thinner,” says Nonye Uddoh, Pharm.D., a clinical pharmacist with UnitedHealth Group, in Silver Spring, Maryland. “It works by blocking a clotting protein called Factor Xa. Factor Xa is one of several clotting factors in our blood.”

The brand name drug was originally approved by the FDA in 2012 to be manufactured by Bristol-Myers Squibb and marketed by Pfizer. At the time, the medication was highly anticipated by cardiologists who were excited by its potential to help patients with certain blood clotting risks. Eliquis was the third oral anticoagulant (blood thinner) to receive FDA approval. However, this is the agency’s first approval of an Eliquis generic. 

Direct oral anticoagulants like Eliquis have largely replaced a drug called Coumadin (warfarin), an older treatment that requires more careful monitoring and has many potentially serious drug interactions. Patients taking Eliquis do not need repeated blood testing, making the treatment more accessible to many people. Xarelto is another newer and popular alternative to Eliquis.

RELATED: Eliquis vs. Xarelto

What are the blood-clotting conditions that Eliquis treats?

According to the FDA, doctors may prescribe Eliquis for the following reasons:

  • To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 
  • To prevent deep vein thrombosis (DVT) in the legs, which may lead to pulmonary embolism (PE) in the lungs in patients who have undergone hip or knee replacement surgery. 
  • To treat DVT and PE and reduce the risk of recurrent DVT and PE following initial therapy.

All of these conditions are dangerous—even life-threatening—and all involve blood clots. 

“A stroke occurs when there is a blood clot in the brain which blocks the flow of oxygen to brain cells,” Dr. Uddoh says. “Systemic embolisms are caused by the development of blood clots in the deep veins of the legs (called DVT) or in the lungs (called PE).”  

DVT causes pain and swelling in the leg near the blood clot. If left untreated, the blood clot can move to the lungs, causing PE. This is a very serious condition that includes symptoms like chest pain, which may get worse when you breathe deeply or cough, dizziness, fainting, coughing up blood, shallow breathing, rapid or irregular heartbeat, and shortness of breath.

Atrial fibrillation and joint replacement surgery increase risk of stroke, DVT, and PE. Eliquis, and the Eliquis generic, can decrease that risk.

RELATED: Do you have to take blood thinners for AFib?

How do you take Eliquis?

According to the manufacturer, Eliquis is taken as a 2.5 or 5 mg tablet by mouth twice daily.

How much does Eliquis cost?

Patients can purchase a starter pack with a one-month supply of Eliquis for about $531, depending on which pharmacy they use. However, insurance usually covers the bulk of that price. Patients with commercial insurance usually pay about $43 per month. Medicare Part D and Medicare Advantage plans also cover Eliquis, lowering the price to only $19 for some customers.

When will generic Eliquis become available for purchase?

The FDA generic approvals for Eliquis (apixaban) went to two drug companies: Micro Labs Limited and Mylan Pharmaceuticals, Inc. However, these two companies have not yet announced when U.S. sales will begin. Generic pricing is not yet available.