FDA Approves First Generic Version of Eliquis, Offering Cost Savings for Patients
HOME | DIABETES EDUCATION |FDA APPROVES FIRST ELIQUIS GENERICS TO PREVENT STROKE, BLOOD CLOTS
The FDA recently approved the first-ever generic versions of Eliquis (apixaban), a medication that helps prevent stroke, blood clots, and embolisms. The generics will offer lower-cost alternatives for people who struggle to afford brand-name Eliquis. Eliquis and generic apixaban also offer some advantages over similar drugs such as warfarin (Coumadin, Jantoven), which we’ll get into below.
Key Takeaways
- The FDA approved the first generic versions of Eliquis (apixaban) in late 2019, granting approval to two manufacturers to produce generics.
- However, legal appeals and patent disputes have prevented those generic manufacturers from bringing their products to market so far.
- The makers of brand-name Eliquis were granted a patent extension until November 2026. This means affordable generic Eliquis likely won’t be available in the U.S. until 2026 at the earliest.
- Eliquis is an important anticoagulant medication used to reduce the risk of stroke and treat blood clots. It can be very expensive, so cheaper generic versions are highly anticipated.
- Patients who want to access generic Eliquis right away do have some options through licensed online pharmacies based in Canada and other countries.
What Does Eliquis Treat?
Eliquis and its generic prevent blood from clotting and are approved for several purposes.
First, they can be prescribed to people with nonvalvular atrial fibrillation to reduce the risk of stroke and blood clots in other parts of the body (embolism). Nonvalvular atrial fibrillation causes the heart to beat irregularly, which can lead to blood clots. These clots can travel to other parts of the body, such as the brain or lungs.
Eliquis can also treat blood clots in the legs or thighs (deep vein thrombosis) and in the lungs (pulmonary embolism), and prevent them from happening again.
Lastly, Eliquis can help prevent deep vein thrombosis in people who have had hip or knee replacement surgery.
Why is Generic Eliquis a Big Deal?
In short, brand-name Eliquis can be an expensive medication, but it’s potentially safer and requires fewer lifestyle restrictions compared to similar medications. A cheaper, generic version of Eliquis could mean that more people will be able to access it.
Eliquis belongs to a class of drugs known as novel oral anticoagulants. These medications work similarly to warfarin, which has been around for more than 60 years.
However, there are some real differences between Eliquis and warfarin. One is the cost. Warfarin has been available as a generic in the U.S. for more than 2 decades. The average retail cost for the most common prescription of warfarin is $24. The average retail cost for the most common prescription of Eliquis? $535.
But even though warfarin may be a fraction of the cost of brand-name Eliquis, it requires regular blood testing to make sure it’s working properly. People taking it also have dietary restrictions. Not to mention more drugs and supplements interact with warfarin compared to Eliquis.
Warfarin and Eliquis both raise the risk of bleeding and bruising. But in research, Eliquis has been shown to have up to a 58% lower risk of bleeding in or around the brain — which can be life-threatening. And it takes effect within a couple of hours.
How to save on Eliquis
There are ways to save on Eliquis, which is only available as a brand-name medication. GoodRx can help you navigate between patient assistance programs and copay savings cards to save money on your prescription.
- Save with patient assistance programs. If you’re uninsured or underinsured, you may be eligible for Eliquis’s patient assistance program, which offers the medication free of cost.
- Save with a copay savings card. If you have commercial insurance, you may be eligible to pay as little as $10 for Eliquis using a savings card from the manufacturer.
When will generic Eliquis be available?
It’s not clear. The FDA has approved applications from drug makers Micro Labs Limited and Mylan Pharmaceuticals Inc. to produce generic Eliquis. But the maker of brand-name Eliquis, Bristol-Myers Squibb, and its partner, Pfizer, are fighting to prevent generic versions from getting to market for several more years. As the original manufacturers, they own a patent that prevents generics from being introduced until the patent expires. That patent was extended from February 2023 to November 2026. Both drug makers say that’s when generics can be made available.
What are common side effects of Eliquis?
Eliquis is a blood thinner, which means it reduces blood clotting. This effect can raise your risk of bleeding, which can be severe. You may also bruise more easily while taking Eliquis.
Other side effects include:
- Rash
- Nausea
- Fainting
- Anemia (too few red blood cells)
Eliquis also comes with a warning not to stop taking it suddenly. Doing so can increase your risk of blood clots and stroke.
Which medications interact with Eliquis?
Two types of medications, P-glycoprotein inhibitors and CYP17 inhibitors, can interact with Eliquis and affect the level of the medication in your body.
P-glycoprotein inhibitors include a range of medications. Some examples include:
- Clarithromycin (Biaxin)
- Erythromycin (Ery)
- Ritonavir (Norvir)
- Verapamil (Calan)
- Ketoconazole (Nizoral)
- Duloxetine (Cymbalta)
- Sertraline (Zoloft)
- Paroxetine (Paxil)
- Omeprazole (Prilosec)
Currently, the only CYP17 inhibitor on the market is abiraterone (Zytiga, Yonsa), which is used in the treatment of prostate cancer.
Always tell your doctor about all the medications and supplements you are taking before adding any new medications to your routine.
The FDA approved a generic version of Eliquis, but it won’t be available for several years
The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.
“Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”
https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis
Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines.
For at-risk patients, such as those with, or at risk for, DVT, or nonvalvular atrial fibrillation, the risk of stroke related to blood clots forming in the body and traveling to the brain is a serious concern. Atrial fibrillation is a heart rhythm problem that can potentially cause such blood clots. According to the Centers for Disease Control and Prevention, it is estimated that between 2.7 and 6.1 million people in the U.S. have atrial fibrillation. Many of these individuals use anticoagulants or anti-clotting drugs to reduce that risk.
Apixaban will be dispensed with a Medication Guide for patients that provides instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding.
There is an increased risk of thrombotic events, which occur when blood clots form inside a blood vessel, or strokes if a patient stops using apixaban too early. Additionally, epidural or spinal hematomas (bleeding outside of blood vessels) may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Health care professionals should consider these risks when scheduling patients for spinal procedures.
Patients with prosthetic heart valves should not take apixaban. Apixaban was not studied in patients with atrial fibrillation caused by a heart valve problem. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban.
The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc. Please contact the manufacturers for information about the medicine’s availability.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA approves the first Eliquis generic, apixaban
The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of Eliquis (apixaban) tablets. Eliquis is a blood thinner medication that helps prevent stroke and treat blood clots.
The FDA approval was granted to generic drug manufacturers, Micro Labs Limited and Mylan Pharmaceuticals. This is the first time a generic version of Eliquis has been approved.
Eliquis belongs to a class of medications known as novel oral anticoagulants (NOACs). It was the third NOAC to be approved by the FDA, after Pradaxa and Xarelto.
Eliquis works by blocking Factor Xa, an enzyme involved in blood clotting. Preventing clots helps reduce the risk of stroke and treats blood clots like deep vein thrombosis (DVT) and pulmonary embolism (PE).
The availability of generic Eliquis (apixaban) is exciting news for patients. Generic drugs are much less expensive than brand-name versions. The significantly lower cost of generic apixaban could allow more patients access to this important medication.
According to the manufacturers of Eliquis, the average monthly cost is about $480 for brand-name Eliquis. The generic version of apixaban is expected to cost significantly less once it becomes available.
While generic Eliquis has been approved by the FDA, it is not yet clear when it will actually reach the market and be available to patients. The makers of brand-name Eliquis are working to delay generic competition.
Originally, Eliquis was expected to lose patent protection in 2023 when generics could launch. But the manufacturers were granted a patent extension until November 2026.
So the arrival of affordable generic apixaban for patients in the U.S. will likely not occur until 2026 at the earliest. Those interested in accessing generic Eliquis right away do have some options through licensed online pharmacies based in Canada and other countries where generic apixaban is already available.
When generic Eliquis does become accessible in the U.S., it will provide a lower-cost alternative for preventing strokes and treating blood clots for the millions of patients prescribed Eliquis each year. Patients should speak to their doctor for advice about accessing generic apixaban once available.
Apixaban, The Generic for Eliquis, is Available and Affordable
Good news: In Canada and internationally, generic apixaban is available now. Americans can ship it directly to their front door through Polarbearmeds.com.
The generic for Eliquis is still on its way in the United States. (The latest reports indicate that the earliest availability for American apixaban generic is 2026.)
Various patent protections and government regulations in the US delayed the approval of generic apixaban until late 2019. Even though manufacturers immediately started working on generic apixaban, it takes several years to produce a new drug in America. So it’s going to be a little while before the apixaban generic is available in the United States.
Fortunately, patients taking Eliquis to reduce the risk of stroke don’t have to wait for lower prices or pay the shockingly high retail price in the United States anymore.
By ordering apixaban generic through an international or online Canadian pharmacy, you can save big on this blood clotting medication now instead of waiting until 2026.
Is There a Generic for Eliquis?
There is a generic for Eliquis – apixaban generic. It will provide similar benefits as its brand-name alternative.
Patients with nonvalvular atrial fibrillation and other heart issues can take Eliquis or generic apixaban as a preventative measure to reduce the risk of blood clots forming in the first place.
Apixaban generic is available in some countries, but not yet in the United States.
However, it is available in Canada – and, fortunately for American patients, select online international Canadian pharmacies ship to patients in the United States.
We do, at Polarbearmeds.com – and we go above and beyond to make the shopping and shipping process as easy as possible for you.
Why Do People Want a Generic Eliquis?
People want a generic Eliquis because Eliquis is safe, doesn’t have many side effects, and the brand-name drug is incredibly expensive.
Eliquis (apixaban) helps prevent blood from clotting. Eliquis is approved to support people managing several different heart conditions.
For example, people with blood clots in their legs (deep vein thrombosis) or their lungs (pulmonary embolism) can take Eliquis or apixaban to treat current clots and prevent them from returning.
Why is Eliquis an In-Demand Medication?
Previous drugs that functioned similarly, such as warfarin, require complex administration. For example, patients treating blood clots with warfarin must perform frequent blood tests, avoid specific foods, and carefully consider the other medications and supplements they use.
Taking Eliquis is a much simpler experience, with fewer to-dos and restrictions attached.
In addition, Eliquis is a lot safer than its alternatives.
One study even showed that patients on Eliquis suffered fewer instances of intracranial hemorrhage, or brain bleeding, than patients on similar drugs.
Of course, those clear improvements don’t come without a cost.
How Much Does Eliquis Cost in America?
In America, Eliquis is still a relatively new drug. Because the generic is still on the way, its manufacturers can keep prices very high.
American patients pay about $315.00 for a thirty-day supply – or around $10.50 for a single pill.
This is already significantly more expensive than it was in early 2022. Inflation, as well as other conditions affecting pharmaceutical prices, is certainly taking a toll.
Alternatively, American patients can save significantly on either brand-name Eliquis or generic apixaban through NorthWestPharmacy.com.
We sell an eight-week supply of Eliquis for approximately $240.00, or about $4.30 per pill (up to 59% savings).
You can also buy a one-month supply of generic apixaban through NorthWestPharmacy.com for around $80.00, or about $2.60 per pill.
When Will Generic Eliquis Be Available In America?
After generic apixaban was approved in the United States in December 2019, two manufacturers submitted plans to produce generics. Their plans were approved in July and September of 2020.
With those approvals, the manufacturers were set to produce affordable generic apixaban. Unfortunately, the pandemic and its associated supply chain issues made it difficult for many industries to progress on new projects.
In addition, the manufacturers associated with brand-name Eliquis are fighting hard to keep a generic from hitting the market.
Recently, they were able to extend their patents protecting Eliquis until late 2026 – which means that 2026 is the earliest Americans can expect apixaban in their local pharmacies.
How Much Will Generic Apixaban Cost in the United States?
Generics are usually much less expensive than their brand-name counterparts. Often, they’re approximately 80-85% cheaper.
Unfortunately, the American price is still hypothetical at this point.
Generic apixaban could take even longer to become available in the US than expected, if the brand-name patent holders decide to extend their patents again – or if market and supply chain conditions continue to make it difficult for the industry to fuel new projects.
Finally, when generic apixaban does hit American pharmacy shelves, it could be priced higher than other generics, anyway. Its manufacturers know very well that it’s going to be a popular option, with little competition.
American patients who want a reliable way to source lower-cost apixaban now should check out the low prices and stress-reducing processes at an international online Canadian pharmacy – at the very least, to benefit from lower prices until the American Eliquis generic hits local shelves.
The Road to Generic: Why Is It Taking This Long?
Generic apixaban is, as of 2022, available in other parts of the world – but not in the United States.
What’s the hold-up?
In short, the drug approval process in America (even for generics!) is a long and winding road. Even though generic apixaban has been approved in the United States, it still has several years to go before it’s easily available in American markets.
Getting a Drug Approved in America
When a pharmaceutical company wants to get a new drug approved in the United States, it’s got to go through an extensive and expensive process, usually lasting around 12 years.
It can be frustrating to wonder where the years go.
The company starts with a sample of their new drug. Next, they must take it through a series of preclinical and clinical trials, submit it for FDA review, and then keep up with post-market safety monitoring best practices.
The trials themselves can take a very long time.
Preclinical trials, or those involving animals, may only take a couple of years. Clinical trials, on the other hand, require finding hundreds of volunteers, figuring out how to design studies that are as safe for those volunteers as possible, and following up with those volunteers (often for years after the official study finishes) to try and make sure the drug doesn’t have any unexpected long-term side effects.
After several clinical trials (e.g., with volunteers with and without the target disease, in increasing numbers, with varying doses of the to-be-approved drug), the manufacturer will have an incredible amount of data to sift through.
Data analysts working with the manufacturer will go through that data, see if they can find any patterns, remove any unhelpful data (e.g., from volunteers who didn’t follow study rules), and package the data nicely for submission to the FDA.
This, too, can take a very long time – especially for more extensive studies that took several data points from thousands of volunteers over several years.
After this, the FDA reviews all of the data (a process that can take ten months) and either approves or disapproves the new drug. If approved, the manufacturer can move forward with production.
Producing Generic Drugs in America
It may be clear why producing a new drug takes so long.
But why is there a years-long approval and production timeline associated with generics? Shouldn’t generics manufacturers be able to reuse some of the same data, as they’re working with the same active ingredient?
They can. Manufacturers seeking to produce generic apixaban don’t have to repeat clinical trials.
Instead, they can skip to the Abbreviated New Drug Application (ANDA). As its name implies, it’s a shorter process than the normal application process.
It can still take years.
And generic drug companies still need to do some testing. After all, generics aren’t exactly the same as brand-name drugs, and it’s key to ensure that the slight differences don’t affect patient safety or the drug’s efficacy.
For example, one of the critical tests that generic manufacturers need to perform is drug efficacy. They must demonstrate that the same amount of their generic drug hits the patient’s bloodstream as the brand-name alternative. They also need to show that the drug starts working in a similar amount of time.
Of course, once generic drug companies achieve approval for their new product, the brand-name patent holder can still try to block them from producing the drug.
That’s where generic apixaban currently is in America – and there’s no guarantee that, even in 2026, the brand-name patent holders won’t file to extend their patent again.
Patients need a viable, reliable, and immediately available source of low-cost apixaban right now.
At polarbearmeds.com, that’s precisely what we offer.
FAQs
What is Eliquis used for?
Eliquis is an anticoagulant used to prevent stroke in patients with atrial fibrillation. It also treats and prevents deep vein thrombosis (DVT) and pulmonary embolism (PE).
When will generic Eliquis be available?
The earliest generic Eliquis could hit the U.S. market is 2026 due to patent extensions granted to the maker of brand-name Eliquis.
Why is generic Eliquis not available yet?
The manufacturers of brand-name Eliquis are fighting to delay generics through patent lawsuits and extensions. This has prevented FDA approved generics from launching so far.
Where can I access generic Eliquis now?
Licensed online pharmacies in Canada and other countries sell affordable generic apixaban that can be ordered by patients in the U.S.
How much does Eliquis cost?
Brand-name Eliquis costs about $480 per month without insurance. The future generic could be 80-85% cheaper.
