Generic Eliquis
Editor’s note: FDA originally announced the approval of generic equivalents to Eliquis in 2019, and updated that information the next year. We are publishing this information as a response to reader requests for more information about generic Eliquis.
FDA Approves First Generic Versions of Eliquis (Apixaban) – Expanding Access to Affordable Anticoagulants
The FDA has approved the first generics of Eliquis (apixaban), a widely used blood thinner designed to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for deep vein thrombosis (DVT) and pulmonary embolism (PE) prevention, especially after hip or knee replacement surgery.
Milestone in DOAC Generics
These approvals mark a major milestone as the first generics of a direct oral anticoagulant (DOAC), improving access to more affordable, safe, and effective treatment options. Unlike older anticoagulants, DOACs do not require frequent blood testing.
Serious Risks
While apixaban is a valuable treatment option, serious risks include increased bleeding, thrombotic events if discontinued too early, and spinal hematomas in certain patients undergoing spinal procedures. Patients with prosthetic heart valves should not take apixaban, and the drug was not studied in atrial fibrillation caused by heart valve problems.
FDA Approvals
The FDA granted approvals to Micro Labs Limited and Mylan Pharmaceuticals Inc., reinforcing the agency’s commitment to enhancing generic competition and expanding patient access to critical medications.
Read the FDA press release here.
Please note: this information is a summary of information provided by the U.S. Food and Drug Administration (FDA). It does not promote or otherwise recommend any pharmaceutical product.