Eliquis to face generic competition in late 2026?
Bristol Myers Squibb (BMS) and Pfizer’s oral blood thinner – Eliquis® (Apixaban) was approved in the United States in December 2012 to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation. The drug gained its subsequent approvals from the U.S. Food & Drug Administration (FDA) in 2014 to reduce risk of blood clots following hip or knee replacement surgery and for the treatment of deep vein thrombosis and pulmonary embolism.
Originally expiring in 2022, Eliquis®’s product patent US 6,967,208 has been granted a patent term extension of 1526 days making it to expire in November 2026. Following the suit of Abbvie and J&J, BMS has erected a wall of granted patents and patent applications to stall the entry of generics for a significant time and to enable its top selling oral anti-coagulant to keep bringing in swathes of cash. The last formulation patent of Apixaban is set expire in 2031.
In 2017, in a Hatch-Waxman Act patent infringement case, BMS and Pfizer asserted two Orange Book-listed patents – US 6,967,208 and US 9,326,945, which generally described and claimed chemical compounds, including Apixaban, and Apixaban formulations, against Mylan Pharms (now Viatris) who sought approval from the U.S. FDA to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of Apixaban prior to the expiration of BMS’ patents. In a judgement in September 2021 by the U.S. Court of Appeals for the Federal Circuit, the validity of US’208 and US’945 was confirmed and accordingly, the partners managed to fend off the generic competition until April 2028 (as per settlement with the ANDA filers).
ANDA applicants – Impax labs, Indoco, Sunshine Lake, Sandoz Inc, Sigmapharm Labs, Hetero Labs, Dr Reddy’s Laboratories Inc, Lupin Pharms, Prinston Pharma Inc, Teva Pharms USA Inc, Torrent Pharms LLC, Sun Pharm Industries, Accord Healthcare, Zhejiang Yongning Pharmaceutical Co Ltd who have been awarded tentative approvals by the U.S. FDA will now have to wait until early 2028 to bring their generic versions to the market.
The sales this blockbuster drug raked in till the last quarter of 2023 (Q3’2023) was 12.2 billion US dollars. Market analysts have predicted that Pfizer might lose up to $20 billion in sales due to patent expirations starting in 2026. However, with its acquisition of MyoKardia in 2020 for $13.1 billion, BMS has gained Mavacamten, a promising drug with the potential to address a significant unmet medical need of heart patients and might help to offset the losses due to Eliquis’ patent expiration.