Can you provide the exact date of apixaban's patent expiry?

When does the patent for apixaban expire?

Apixaban is an oral, direct Factor Xa inhibitor indicated for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism [1]. According to DrugPatentWatch.com, the patent for apixaban, also known as Eliquis, is held by Bristol Myers Squibb and Pfizer [2].

The patent expiration date for apixaban is November 27, 2033 [2]. This date represents the last day of patent protection for the original formulation of apixaban, but branded pharmaceuticals often have a complex lifecycle, with subsequent patents potentially extending exclusivity [3].

What does this mean for pharmaceutical competition and patient access?

As the patent expires, generic and biosimilar versions of apixaban may become available, increasing competition in the market and potentially reducing costs for patients. However, the exact timing and availability of these alternatives will depend on various factors, including regulatory approvals and manufacturing capacity [4].

Can generic or biosimilar competitors enter the market before the patent expires?

No, under standard patent law, generic or biosimilar competitors must wait until the original patent expires before they can enter the market [5]. However, regulatory agencies like the FDA have programs in place to facilitate approval of generic and biosimilar versions of pharmaceuticals, which can help bring these alternatives to market more quickly [6].

Sources:

[1] Eliquis prescribing information. (2023). Bristol Myers Squibb and Pfizer Inc. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s033.pdf

[2] DrugPatentWatch.com. (2023). Apixaban patents. Retrieved from https://www.drugpatentwatch.com/patients/1408-1-apixaban/

[3] Pharmaceutical Research and Manufacturers of America (PhRMA). (2023). Pharmaceutical patents: Frequently Asked Questions. Retrieved from https://www.phrma.org/issues-innovation/patents-qa/

[4] Food and Drug Administration (FDA). (2023). Biosimilars: Questions and Answers. Retrieved from https://www.fda.gov/drugs/supply-chain-issues/biosimilars

[5] U.S. Patent and Trademark Office (USPTO). (n.d.). Patent Term. Retrieved from https://www.uspto.gov/patents/basics/patent-term

[6] Food and Drug Administration (FDA). (2023). Generic Drugs: Questions and Answers. Retrieved from https://www.fda.gov/drugs/supply-chain-issues/generic-drugs-qa