FDA approves the first Eliquis generic, apixaban

Good news for people who are at high risk for stroke or are suffering from deep vein thrombosis (DVT) or pulmonary embolism (PE). The FDA (U.S. Food and Drug Administration) has approved the first Eliquis generic, apixaban, which will be a lower-cost blood thinner alternative. Generic Eliquis will be much more affordable than the brand-name drug once it’s available for sale. The initial FDA approval for the generic versions of Eliquis was provided to generic drug manufacturers, Micro Labs Limited and Mylan Pharmaceuticals, Inc.

What is Eliquis?

Eliquis (apixaban) is a blood thinner (anticoagulant) that is used to:

  • reduce the risk of stroke and blood clots in people who have atrial fibrillation (a heart rhythm disorder)
  • treat deep vein thrombosis (DVT) and pulmonary embolism (PE)
  • reduce the risk of DVT and PE happening again

It works by blocking a protein called Factor Xa. This protein is needed for blood clotting.

Eliquis is manufactured by Bristol-Myers Squibb and marketed by Pfizer. It was first approved by the FDA in 2012.

Is there a cheaper alternative to Eliquis?

Eliquis was the third blood thinner to be approved by the FDA. This approval was followed by two other alternative anticoagulants, Pradaxa (dabigatran) and Xarelto (rivaroxaban). However, this is the FDA’s first approval of a generic for Eliquis (apixaban).

Oral anticoagulants such as Coumadin (warfarin) have been commonly replaced by Eliquis and Xarelto. Warfarin requires much more careful screening and monitoring for potential drug interactions which may be serious. Fortunately, people who are prescribed Eliquis do not need this extra monitoring including multiple blood tests which will enable greater access to this drug.

RELATED: Eliquis alternatives: which other blood thinners can I take?

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What type of blood clotting does Eliquis treat?

Doctors may prescribe Eliquis for the following indications, according to the FDA:

  • Reducing the risk of stroke and non-central nervous system (non-CNS) systemic embolism in adult patients with atrial fibrillation (AF)
  • Treating and preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults
  • To prevent venous thromboembolic events (VTE) in adult patients who have undergone hip or knee replacement surgery
  • To reduce the risk of recurrent VTE after an initial VTE event

Blood clots are a serious condition, and possibly life-threatening, that can lead to strokes, heart attacks, and even death. Eliquis is a life-saving medication for people who are at risk for these types of events.

Is there a generic for Eliquis available yet?

There is currently no generic for Eliquis available yet in the United States.

How much will the generic cost?

The Eliquis generic name is apixaban. The price of generic apixaban has not been announced yet. However, it will likely be much cheaper than the brand-name drug, which costs around $529 for a 30-day supply, according to the manufacturer’s website.

When will generic Eliquis be available?

The FDA has not announced a specific date when generic Eliquis will be available so there is no Eliquis generic release date at this time. It normally takes several months for a generic to be available for sale following the generic approval, however, the U.S. Patent and Trademark Office had granted Eliquis extended protection on its patent. The Bristol Myers Squibb-Pfizer Alliance recently announced in a press release that the earliest that generic manufacturers are permitted to launch their apixaban products is April 1, 2028, subject to additional appeals and challenges.

How do you take Eliquis?

Eliquis is taken orally, with or without food. It is available as a 2.5mg tablet and 5mg tablet. The usual dose is:

  • 5 mg twice daily for those who have atrial fibrillation and are also 75 years old or older, have a lower body weight (less than 60 kg), or have certain kidney problems
  • 2.5 mg twice daily for all other patients with atrial fibrillation
  • 5 mg twice daily for those who are treating DVT or PE, and also have a Creatinine Clearance of 15-29 mL/min
  • 2.5 mg twice daily for all other patients treating DVT or PE

Your doctor may adjust your dose depending on your individual situation.

What are the side effects of Eliquis?

The most common side effects of Eliquis are:

  • bleeding
  • bruising
  • nosebleeds
  • indigestion
  • diarrhea

You may have a higher risk of bleeding if you take Eliquis with other medicines that increase your risk of bleeding (including over-the-counter medications), such as aspirin, heparin, warfarin, nonsteroidal anti-inflammatory drugs (called NSAIDs), selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or other medicines to help prevent or treat blood clots

These are not all of the possible side effects of Eliquis. You should always seek the medical advice of a licensed healthcare provider for any questions or concerns relating to your medical condition or treatment.

How much does Eliquis cost?

In 2022, the manufacturer’s (Bristol-Myers Squibb) website listed the price of Eliquis as $522 for a 30-day supply without insurance. People who have prescription insurance through Medicare pay $37 on average for Eliquis, according to the manufacturer of Eliquis. The manufacturer also states that some Medicare patients with Part D coverage may pay as little as $10 per month for Eliquis through the use of a Medicare Part D prescription drug plan or a Medicare Advantage plan that includes prescription drug coverage.

Why is Eliquis so expensive?

Eliquis is so expensive because it is a brand-name medication. Brand-name drugs are always more expensive than generic drugs. In contrast, the FDA-approved generic version of Eliquis (apixaban) will be much cheaper.

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Also read

Sources (4)

  1. FDA - News Release - FDA approves first generics of Eliquis

  2. BMS - Press release - U.S. FDA Approves ELIQUIS® (apixaban) to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

  3. Eliquis official website - pricing information

  4. BMS - press release - The Bristol Myers Squibb-Pfizer Alliance is pleased with the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis® Patents

The content on this website is intended for information purposes only. It does not constitute medical advice. The information on this website should not be relied upon and is not a substitute for professional medical advice. You should always speak to your doctor regarding the risks and benefits of any treatment.
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