The Birth of an All-Time Blockbuster Achieved Through the Pfizer-BMS Alliance

Eliquis is a leading oral anticoagulant co-developed by Bristol Myers Squibb (BMS) and Pfizer (PFE) in 2007. The two companies formed an aggressive partnership, with Pfizer contributing 60% of the development costs and paying a $250 million upfront fee, before entering the global market. This drug selectively inhibits Factor Xa, a key factor involved in blood coagulation, thereby fundamentally blocking the formation of blood clots. Based on the strong sales capabilities of both companies and its clinical excellence, Eliquis recorded combined sales of approximately $20.7 billion (BMS: $14.4 billion, Pfizer: $7.366 billion) in 2024, dominating the global pharmaceutical market.

The ARISTOTLE Phase 3 Trial Validates and Revolutionizes Prescription Guidelines

Eliquis's market dominance began with the results of the ARISTOTLE study, a landmark Phase 3 clinical trial involving 18,201 patients. In this trial, Eliquis demonstrated superior efficacy, reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) by 21% compared to warfarin, the existing standard treatment. Furthermore, it reduced the incidence of major bleeding, the most critical adverse event, by 31%, and improved overall mortality (all-cause mortality) by 11%, demonstrating its complete safety. As a result, healthcare professionals began to select Eliquis as the primary treatment option, as it does not require regular blood tests (INR monitoring) and has minimal interactions with food.

The Threat of Patent Cliff in Europe and the United States Endangers its Exclusive Position

Currently at the peak of the market, Eliquis faces a major challenge in the form of an impending patent expiration (Patent Cliff). In Europe, the patent will expire as early as 2026, and in the United States, the world's largest market, the exclusivity period for the active ingredient patent will end in 2028, paving the way for the entry of numerous generic copies. The onset of this patent cliff will inevitably lead to a sharp decline in the sales of the original drug in the short term, which will have a significant impact on the performance of the two partner companies. Therefore, both companies are implementing aggressive defense strategies to expand new indications or transition patients to next-generation pipelines before the patent expires.

The Implementation of the U.S. IRA Drug Price Negotiation and the Changing Landscape of the Global Anticoagulant Market

In addition to patent expiration, the fact that Eliquis has been selected as the first drug subject to price increases under the U.S. Inflation Reduction Act (IRA) is also a major burden. Starting in 2026, the Maximum Fair Price will be applied within the U.S. Medicare program, which will have a direct impact on the actual price reduction. This is likely to have a negative impact on the profitability indicators in the market share competition with other competing drugs such as Xarelto (Rivaroxaban) and Pradaxa (Dabigatran).

Ultimately, global Big Pharma companies are focusing on expanding direct patient support programs and diversifying their revenue streams to respond to the rapid price reductions and maintain market share.