Apixaban is a prescription medication, an anticoagulant, commonly known as a blood thinner. It reduces the risk of stroke and systemic embolism in individuals with nonvalvular atrial fibrillation. It also prevents and treats deep vein thrombosis (DVT) and pulmonary embolism (PE). Apixaban was initially approved for medical use in the United States in December 2012. Patients often ask about its availability, particularly concerning lower-cost options.
Understanding Apixaban Availability
The brand-name version of apixaban, known as Eliquis, is widely available in pharmacies. While the U.S. Food and Drug Administration (FDA) approved the first generic applications for apixaban in December 2019, these generic versions are not yet broadly available in the United States. This situation stems from ongoing patent litigation and agreements between brand-name manufacturers and generic drug companies.
Original patents for apixaban were anticipated to expire around 2022. However, Bristol-Myers Squibb and Pfizer, Eliquis’ developers, have defended additional patents related to the drug’s formulation and manufacturing processes. These legal outcomes and settlements have delayed generic apixaban’s market entry. As a result, the earliest expected availability of generic apixaban in the United States is projected for April 1, 2028. In contrast, generic apixaban became available in Canada in 2023.
Factors Affecting Generic Drug Release
A generic drug’s market release involves several stages, often influenced by a complex interplay of legal and regulatory factors. A primary factor is the expiration of patents held by the brand-name drug manufacturer. These patents typically grant exclusive marketing rights for a period, often around 20 years from the patent filing date. Once these initial patents expire, other companies can seek approval to produce generic versions.
Even after patent expiration, generic manufacturers must obtain regulatory approval from bodies like the FDA in the United States. This approval process, known as an Abbreviated New Drug Application (ANDA), requires the generic drug to demonstrate bioequivalence, meaning it works the same way and has the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. Despite FDA approval, brand-name pharmaceutical companies often engage in legal challenges to protect their market exclusivity. They may file lawsuits asserting infringement on secondary patents, such as those covering specific formulations or manufacturing methods, which can significantly delay generic market entry even with regulatory approval.
Accessing Apixaban at Your Pharmacy
Obtaining apixaban, whether the brand-name Eliquis or a future generic version, always requires a valid prescription from a licensed healthcare provider. Individuals interested in this medication should first consult with their doctor to determine if apixaban is appropriate for their health needs and medical history. The healthcare provider can assess the patient’s condition and provide a prescription if warranted.
Once a prescription is obtained, patients can take it to their preferred pharmacy. Pharmacists are valuable resources for information regarding medication availability, potential generic options, and cost considerations. They can check their current stock of apixaban and, if it is not immediately available, can typically order it for pick-up within a short timeframe. Patients are encouraged to discuss any concerns about cost or access with their doctor or pharmacist, as they can provide guidance on coverage or potential patient assistance programs.