Is There a Generic for Eliquis? FDA-Approved Apixaban for Blood Clots

Eliquis (apixaban) is a commonly prescribed anticoagulant medication used to reduce the risk of stroke in certain patients and treat or prevent dangerous blood clots. Since its FDA approval in 2012, Eliquis has become a widely used blood thinning treatment. However, it currently faces no generic competition due to patent barriers delaying availability of cheaper generic alternatives.

This article will explore the need for generic Eliquis, why it is not yet available in the US, when generic access is expected, and how patients can access affordable Eliquis treatment until generic apixaban becomes available. The potential cost savings and benefits of generic competition will also be discussed.

Key Takeaways

• Eliquis (apixaban) is an important anticoagulant medication used to prevent stroke and treat blood clots
• No generic version is currently available in the US market due to patent protections and legal barriers
• FDA approved the first Eliquis generic in 2019 but ongoing appeals have blocked availability so far
• Generic apixaban is expected to be significantly cheaper, improving patient affordability and access
• Alternatives like warfarin or brand-name NOACs are options until generic entrance
• Patent litigation tactics often delay generic drug competition after initial approvals
• Patients and the healthcare system should benefit from having a lower-cost generic Eliquis option

Overview of Eliquis and its uses

Eliquis (apixaban) is an oral anticoagulant medication used to prevent and treat blood clots. It was approved by the FDA in 2012 and is manufactured by Bristol-Myers Squibb and marketed by Pfizer. Eliquis is a novel oral anticoagulant (NOAC) that works by inhibiting factor Xa, a key enzyme involved in blood clotting.

Eliquis is prescribed for the following uses:

• To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (irregular heartbeat)
• To treat and prevent recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE)
• To prevent DVT which may lead to PE in patients who have undergone hip or knee replacement surgery

Compared to older anticoagulants like warfarin, Eliquis does not require frequent blood monitoring and has fewer food and drug interactions. However, it is also significantly more expensive.

The need for a generic version

Currently, there is no generic version of Eliquis available in the US. Brand name Eliquis costs around $500-600 for a one month supply without insurance. This puts the medication out of reach for many patients who could benefit from it.

Having a generic version of Eliquis will make this important medication more affordable and accessible. Generic drugs are typically 80-85% cheaper than brand name versions. Many patients and healthcare providers are eagerly awaiting generic Eliquis to have a lower cost option.

Generic Apixaban Approved But Delayed

In December 2019, the FDA approved the first generic versions of Eliquis, named apixaban. Approvals were granted to two manufacturers – Micro Labs Limited and Mylan Pharmaceuticals Inc.

However, the makers of brand name Eliquis – Bristol Myers Squibb and Pfizer – filed lawsuits to prevent these generic companies from bringing apixaban to market.

In September 2021, a U.S. Court of Appeals ruling protected the Eliquis patent, preventing generic competition until at least April 2028. This means the first generic versions of Eliquis cannot launch in the US until this date at the earliest.

Pricing and Availability of Generic Eliquis

The manufacturers of the brand name Eliquis have succeeded in delaying generic competition until at least April 2028 through court appeals and patent extensions.

This means the first generic Eliquis, apixaban, is still years away from being available to US patients. The exact cost of generic apixaban is unknown, but it is expected to be significantly lower than brand name Eliquis which costs about $500-600 per month.

Generic medications typically cost 80-85% less than brand versions. Based on this range, the monthly cost of generic apixaban could be $75-120 once launched. However, the pricing landscape could change by 2028.

Alternatives Until Generic Eliquis Launch

Until generic Eliquis (apixaban) becomes available in the US, there are some alternatives that patients may consider in discussion with their healthcare providers:

• Other branded NOACs: Pradaxa (dabigatran), Xarelto (rivaroxaban), and Savaysa (edoxaban) are alternatives in the same medication class as Eliquis. They have similar effectiveness but may have slightly different side effect profiles. Their costs are also high.
• Warfarin (Coumadin): An older generic oral anticoagulant. It requires frequent monitoring and dietary restrictions but is very low cost. Patients must get frequent blood tests to monitor dosage.
• Heparin injections: Can be used short-term in hospital to manage blood clots. Requires injection rather than oral administration.
• Aspirin: Low dose aspirin may be an option for some patients though less effective than anticoagulants. It’s extremely low cost but still carries bleeding risk.
• Eliquis patient assistance: Uninsured or underinsured patients may be eligible for discounted or free Eliquis directly from the manufacturer.

Patients should speak with their healthcare providers to weigh alternatives and find the most appropriate treatment for their medical situation. The high monthly cost of branded NOACs makes access a challenge for many patients.

How Eliquis works

Eliquis contains the active drug apixaban which works by inhibiting factor Xa, a key enzyme in the blood coagulation cascade. The coagulation cascade is a series of reactions that leads to blood clot formation.

By inhibiting factor Xa, apixaban prevents the conversion of prothrombin to thrombin. This reduces thrombin generation and activity, disrupting the blood clotting process.

As a result, blood clots are less likely to form in the body. Eliquis provides anticoagulation (blood thinning) to prevent ischemic stroke in AFib patients and treat or prevent recurrence of dangerous blood clots in the veins (DVT/PE).

Unlike some older anticoagulants, apixaban has a direct effect on factor Xa and does not require antithrombin III to work. Eliquis is absorbed quickly by the body and reaches peak effects within 1-3 hours.

Eliquis Dosage and Administration

Eliquis is available in 2.5mg and 5mg oral tablets. The dosage prescribed depends on the medical condition being treated:

For atrial fibrillation:

• Recommended dose: 5mg twice daily
• Reduced dose: 2.5mg twice daily may be used in select patients such as those >=80 years old, weighing <=60kg, or with renal impairment

For DVT/PE treatment:

• Initial: 10mg twice daily for 7 days
• Maintenance: 5mg twice daily

For DVT/PE prevention:

• 2.5mg twice daily

Eliquis can be taken with or without food. It is important to take it consistently at the same times each day and not miss any doses. The duration of treatment depends on the medical condition.

Side Effects of Eliquis

The most common side effect of Eliquis is bleeding. Since Eliquis is an anticoagulant, it can increase the risk of excessive or prolonged bleeding events. These may occur anywhere in the body.

Common bleeding side effects include:

• Nosebleeds
• Bleeding gums
• More frequent or heavy menstrual bleeding
• Bruising
• Blood in urine or stools
• Coughing up blood

Rare but serious bleeding events include bleeding in the brain, severe stomach/intestinal bleeds, and spinal or eye bleeds. Patients on Eliquis should seek immediate medical attention if they experience severe headaches, back pain, blurry vision, bloody vomit, or blood in the urine or stools.

Other possible side effects of Eliquis include indigestion, nausea, rash, liver enzyme changes, and low blood pressure. Eliquis can cause allergic reactions in rare cases. Patients should notify their doctor about any side effects or concerning symptoms that develop while taking Eliquis.

Warnings and precautions with Eliquis

There are some important safety issues and precautions to know when using Eliquis:

• Stopping Eliquis suddenly can increase the risk of stroke and blood clots. Patients should not discontinue it without guidance from their doctor.
• Eliquis can cause spinal/epidural hematomas, a rare but very serious bleeding risk. Patients undergoing spinal procedures should notify their physician about taking Eliquis.
• Eliquis is not approved for use in pregnant women. It is unknown if apixaban passes into human breastmilk.
• People with antiphospholipid syndrome should not take Eliquis as it is not effective in this condition.
• Caution is needed in patients with increased bleeding risks including active ulcers, recent brain or spine injury, bacterial endocarditis, or hemorrhagic stroke.
• Eliquis interacts with certain HIV, antifungal, antibiotic, and anti-seizure drugs. Patients should inform their doctor about all medications they are taking.

The Target population for Eliquis

The patients most likely to benefit from Eliquis treatment include:

• Adults with non-valvular atrial fibrillation to reduce stroke risk
• Those with prior DVT, PE, or other predispositions to blood clots
• Patients undergoing hip/knee replacement to prevent postsurgical DVT/PE
• Individuals at increased risk for blood clots due to restricted mobility, cancer, certain medications, or genetic factors

In nonvalvular AFib, Eliquis is one of the preferred NOAC options per treatment guidelines. For those with prior VTE events, Eliquis helps prevent recurrence when taken long-term. Postsurgical thromboprophylaxis is another FDA-approved use.

Kidney and liver function should be checked before starting Eliquis. It has not been studied and is contraindicated in pregnant women. Eliquis has not been approved for use in children.

How does Eliquis Differ from Warfarin?

Warfarin (Coumadin) is an older oral anticoagulant that was widely used prior to newer NOACs like Eliquis. Here are some key differences:

• Monitoring: Warfarin requires frequent INR monitoring and dosage adjustments. Eliquis does not require lab monitoring.
• Onset: Eliquis starts working within hours while warfarin can take 2-3 days to reach therapeutic levels.
• Interactions: Warfarin has significantly more food and drug interactions compared to Eliquis.
• Dosing: Warfarin dosing is adjusted based on INR results. Eliquis is given in fixed doses.
• Cost: Warfarin is available generically for less than $20 per month. Eliquis costs around $500 monthly without insurance.
• Bleeding risk: Eliquis is associated with about 10-25% less intracranial hemorrhage compared to warfarin.

Eliquis is more convenient due to no monitoring and fewer interactions. However, the high cost of Eliquis makes access a challenge compared to inexpensive generic warfarin.

Is There a Reversal Agent for Eliquis?

There is no specific antidote to reverse the effects of Eliquis if major bleeding occurs. However, andexanet alfa (Andexxa) was approved by the FDA in 2018 as a reversal agent for Eliquis and other factor Xa inhibitors.

Andexanet alfa is a recombinant protein designed to act as a factor Xa decoy. By binding to and sequestering the Eliquis drug, it can rapidly reduce its anticoagulation activity.

Andexanet alfa has been shown to significantly reverse the effects of Eliquis within minutes. This helps control acute major bleeding events.

The lack of an antidote was a limitation of Eliquis and other NOACs compared to warfarin, which can be reversed using vitamin K and clotting factors. The approval of andexanet alfa helps provide an urgent treatment option for life-threatening Eliquis bleeding.

How Eliquis Compares to Other NOACs

There are 3 other NOACs besides Eliquis currently available:

• Xarelto (rivaroxaban)
• Pradaxa (dabigatran)
• Savaysa (edoxaban)

These all target steps in the coagulation cascade to reduce clot formation. Xarelto works similarly to Eliquis by inhibiting Factor Xa. Pradaxa inhibits thrombin. Savaysa also targets Factor Xa but is newer with less real-world data.

Trials comparing NOACs show relatively similar efficacy and safety. But there are subtle differences in pharmacokinetics, monitoring, and bleeding risks that may favor one over another for certain patients.

Importantly, there are no generics available for any NOACs besides Eliquis. So there is no current lower cost option among the NOAC drug class.

FDA Approval of Generic Eliquis

In December 2019, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Eliquis (apixaban) tablets.

The FDA granted approval to two generic drug manufacturers – Micro Labs Limited and Mylan Pharmaceuticals Inc. – to produce generic apixaban.

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. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis

This was an important milestone, as it was the first generic approval for a direct oral anticoagulant medication. Prior to this, Eliquis was only available as a branded product.

Having access to generic alternatives typically lowers drug costs for patients, making important medications more affordable.

However, despite the FDA approval in late 2019, generic Eliquis still has not reached the U.S. market due to ongoing legal barriers and patent extensions.

Court Appeals Delaying Generic Launch

Although the FDA approved generic apixaban in 2019, the manufacturers of brand name Eliquis – Bristol Myers Squibb and Pfizer – took legal action to prevent early generic competition.

They filed lawsuits and succeeded in getting key Eliquis patents restored and extended. This has blocked the generic manufacturers from launching their apixaban products so far.

In September 2021, a ruling by the U.S. Court of Appeals for the Federal Circuit reinforced the patents protecting Eliquis from generic entry until April 1, 2028, at the earliest.

Bristol Myers Squibb has said this 2028 date is when generics can first become available, barring any additional appeals or challenges that further delay generic access.

Benefits of Generics for Patients

When generic drugs become available after a period of patent exclusivity, they typically launch at much lower prices than their branded counterparts.

Generic medications contain the same active drug ingredient and are considered bioequivalent to the brand name version.

The availability of generics provides financial savings for patients and the overall healthcare system. For drugs like Eliquis that cost nearly $500 a month, generics can make treatment more attainable.

One analysis found brand name drug prices were nearly 4 times higher than generic equivalents. On average, generics cost 80-85% less than brand-name retail prices.

Generic competition is important for patient access, especially for costly brand-name medications like Eliquis. Billions of dollars in savings can be realized with lower-priced generic alternatives.

Patent Protections Delaying Generics

Patents play a key role in delaying the availability of generic Eliquis. Patents provide market exclusivity rights, preventing competitors from producing generic versions of a medication for a set period of time.

The purpose of patents is to incentivize innovation by allowing companies to recoup investments in developing new drugs. However, extensive patent protections also delay more affordable generic access.

Key Eliquis patents have been extended into 2026-2028, blocking generic drug manufacturers who already have FDA approval from launching sooner. Brand drug companies often find ways to obtain new patents and extend protections.

The Hatch-Waxman Act established an abbreviated FDA approval pathway for generics. But technicalities enable brand-name manufacturers to “evergreen” patents through court challenges and regulatory loopholes.

Who Benefits from Generic Eliquis?

The key groups that will benefit from generic Eliquis access include:

• Patients with prescription drug insurance, Medicare, or Medicaid coverage: More affordable copays are expected with generic apixaban.
• Uninsured or underinsured patients: Lower out-of-pocket costs will improve access for those paying full retail price.
• Federal and state healthcare programs: Medicaid, Medicare, and the VA healthcare system will save significantly on costs.
• Employers and private insurers: Lower expenses for prescription coverage by switching to generic apixaban.
• Pharmacies: Increased volume and lower purchasing costs for generic apixaban.
• Healthcare system overall: Billions in cost savings nationwide expected from availability of generic Eliquis.

While generic competition benefits consumers, it does negatively impact revenues for the brand name manufacturer. But the overall healthcare savings outweigh short-term revenue losses.

Pricing and Availability Expectations

The manufacturer suggested wholesale price for a one month supply of Eliquis is around $500-600 without insurance. Many patients pay $300-400 even with prescription coverage.

Based on typical pricing patterns, the monthly cost of generic Eliquis could fall between $75-120 when launched. But the actual cost is still unknown.

As for timing, Bristol Myers Squibb indicates 2028 is the earliest generics can enter based on current patents. However, technical factors and litigation could possibly delay generic availability beyond 2028 as well.

The FDA already approved two manufacturers to produce generic apixaban back in 2019. But these companies have been unable to bring their generics to market pending legal challenges.

Once patents and exclusivities finally expire, the approved companies are expected to launch generic Eliquis relatively quickly to compete. But the exact timeline remains uncertain given the barriers.

Global Status of Generic Apixaban

While generic Eliquis access has been delayed in the United States, the situation differs globally.

Apixaban generics are already available in some international markets where patent protections have expired. Canadians have access to low-cost generic apixaban today, for example.

But in the US, the regulatory exclusivities and patent litigation tactics have been effective in preventing generic drug companies from launching so far.

The scenario highlights how the US pharmaceutical patent system enables lengthened monopolies for brand drug makers compared to other countries.

Americans continue to pay 5-10 times more for brand name drugs than peer nations where competitive generic access is faster. Without reforms, access to generic Eliquis may be delayed indefinitely.

Generic Drug Approval Process

Even though generic Eliquis was approved in 2019, it has faced barriers to market entry. Understanding the generic drug approval process provides context on the delay.

For a new brand-name drug, manufacturers must conduct extensive clinical trials to establish safety and efficacy. This enables FDA approval and patent protections.

For generics, manufacturers can file an Abbreviated New Drug Application (ANDA). The ANDA relies on the brand drug research rather than repeating clinical trials.

Bioequivalence studies must still be performed to demonstrate the generic has the same active ingredient, dosage form, strength, route of administration, quality, and performance as the brand name drug.

The ANDA pathway significantly reduces generic drug development time and cost compared to new brand-name medications.

However, brand manufacturers often find ways to file new patents and extend exclusivity beyond the initial patent timeline. This is a tactic used by the makers of Eliquis to prevent generic competition.