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The First Eliquis Generic Apixaban Gains FDA Approval

The First Eliquis Generic Apixaban Gains FDA Approval

Here is good news for those who are at high risk of stroke, suffering from deep vein thrombosis (DVT) or pulmonary embolism (PE), and are prescribed Eliquis. The first generic of this medicine, apixaban, has been authorized by the U.S. Food and Drug Administration (FDA), making it an affordable blood thinner substitute. When the generic Eliquis becomes available, it will be much more affordable than its brand-name equivalent. The initial approval of generic versions of Eliquis was granted to Micro Labs Limited and Mylan Pharmaceuticals. In this blog, we are going to discuss what Eliquis is, why the availability of its generic version is significant, and when it will be available. We will also examine the safety considerations for patients and healthcare providers to mitigate the risks associated with the Eliquis 2.5 mg tablet.

What Is Eliquis?

Eliquis is an anticoagulant (blood thinner) that blocks a blood clotting enzyme known as Factor Xa. The FDA initially approved the brand name “Eliquis” in 2012 for production by Bristol-Myers Squibb and distribution by Pfizer. During this period, the medicine was highly anticipated by cardiologists, who were excited by its potential to help patients with certain blood clotting risks. It is used to:

  • Lower the chances of stroke and blood clots in those who have Afib (atrial fibrillation, a heart rhythm disorder).
  • Treat DVT (deep vein thrombosis) and PE (pulmonary embolism).
  • Lower the chance of rehappening of DVT and PE.

Why Is Generic Eliquis a Big Deal?

In short, the brand Eliquis can be an expensive medication, but it’s safer and requires fewer lifestyle restrictions than similar medications. Eliquis could become more accessible to more people with a cheaper generic version. The FDA approved Eliquis as the third blood thinner. There were two other approved anticoagulants: Pradaxa (dabigatran) and Xarelto (rivaroxaban). However, this is the first time the FDA has approved a generic version of Eliquis (apixaban). Fortunately, Eliquis generic approvals have the following major significance:

1. Cost-Effective Option: Generic Eliquis will provide a more affordable alternative for patients. As the first generic version of this widely used medication, it is expected to reduce the financial burden on individuals and healthcare systems significantly. The cost savings can make anticoagulation therapy more accessible to a broader population.

2. Improved Access: For those with atrial fibrillation or at risk for DVT, the risk of stroke related to blood clots is a serious concern. Eliquis has been a crucial tool in managing this risk. By approving generics, the FDA ensures that more patients can benefit from this effective medication without compromising safety or quality.

3. No Repeated Blood Testing: Eliquis is categorized as a direct oral anticoagulant (DOAC), a type of medication that differs from traditional anticoagulants like warfarin in that it doesn’t necessitate regular blood monitoring. This convenience simplifies treatment for patients and reduces the need for regular clinic visits.

When Will Generic Eliquis Be Available?

In 2019, the FDA granted approval for generic versions of Eliquis (apixaban) from two pharmaceutical companies: Micro Labs Limited and Mylan Pharmaceuticals Inc. However, legal disputes ensued over patent rights between Bristol-Myers Squibb, Pfizer, and generic drugmakers over patent rights. A September 2021 ruling by the U.S. Court of Appeals for the Federal Circuit prevented the entry of generic apixaban into the market for now. According to the manufacturers of Eliquis, generics are expected to be available by April 1, 2028, pending any further legal challenges.

Safety Considerations for Patients and Healthcare Providers

There is no doubt that the availability of more affordable versions of Eliquis is a positive development, but ensuring safety during usage is also crucial. We can take some basic steps to make sure that these medications are used safely.

1. Thrombotic Risk

There is a high risk of thrombotic events associated with Eliquis and its generics when used prematurely. If the anticoagulant effect of a medication is abruptly interrupted, thrombotic events can occur, including strokes. In order to address this issue:

  • Healthcare professionals need to focus on the importance of following a prescription regimen. Patients must be taught how to maintain consistent medication adherence in order to prevent thrombotic complications.
  • Patients need to watch out for signs and symptoms of possible bleeding, such as unusual bruising, bleeding gums, and blood in urine and stools. The patient should immediately tell their healthcare provider about any concerns they have to ensure they are managed appropriately.

2. Spinal Procedures

A significant risk of epidural or spinal hematomas is also associated with Eliquis treatment for spinal procedures. The presence of these hematomas, which are characterized by bleeding outside of blood vessels, can result in serious neurological problems. In order to address this issue:

  • Healthcare providers must conduct a careful risk-benefit analysis before scheduling spinal interventions during Eliquis therapy. A patient’s overall health status, concomitant medications, and the urgency of the procedure should all be considered when assessing risk.
  • A patient undergoing spinal surgery should tell their healthcare provider about Eliquis therapy to determine if the risk is appropriate and if precautions are needed, such as temporarily halting anticoagulation or switching anticoagulants.

3. Prosthetic Heart Valves

The use of Eliquis and its generics is contraindicated in patients with prosthetic heart valves. Clinical data do not adequately support Apixaban’s safety and efficacy in this patient group, so alternative anticoagulation strategies should be considered. Those receiving Eliquis therapy, whether the brand-name medication or its generic equivalent, need to be monitored to ensure safe use. 

The healthcare professional and patient can work together to minimize adverse effects by understanding and addressing potential risks. In addition, if you are looking for a reliable and affordable option to buy Eliquis online, you should look further at Polar Bear Meds, your best Canadian online pharmacy. 

The Bottom Line

It is a major achievement for healthcare accessibility that the FDA has authorized the first generic version of Eliquis, apixaban. Eliquis, a blood thinner that manages strokes and blood clot risks, often comes with a steep price tag. Eliquis generic offers cost-effective access to a broader population. Generics are expected to be available by April 2028 despite legal battles. It is crucial to collaborate with patients and providers to understand risks, such as thrombotic risks upon premature discontinuation and precautions for spinal procedures and prosthetic heart valves. Generic Eliquis represents a significant step towards affordable and accessible healthcare.

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