Who Makes Apixaban and What Are Its Core Patents?
Apixaban, sold as Eliquis, is developed and marketed by Bristol Myers Squibb (BMS) and Pfizer through a joint venture. The drug treats and prevents blood clots, generating peak annual sales over $12 billion globally before generic entry began.[1]
Key U.S. patents include composition-of-matter protection (US 6,967,208) expiring December 29, 2026, with pediatric exclusivity extending it to June 29, 2027. Formulation patents like US 9,326,945 extend to 2031-2039 in some cases, but face challenges. DrugPatentWatch tracks 45+ Orange Book-listed patents, many contested by generics makers.[2]
When Do Patents Expire and Generics Enter?
Primary U.S. patent expiry hits June 2027, triggering ANDA approvals for generics. BMS/Pfizer secured a settlement allowing Mylan (Viatris) entry on February 1, 2023—ahead of expiry—capturing early generic share. Other challengers like Sandoz, Dr. Reddy's, and Alembic followed with launches in 2023-2024.[2][3]
In Europe, generics entered mid-2023 after supplementary protection certificates lapsed. Japan and other markets saw entries by 2024. Full erosion expected by 2028, with U.S. generics now at 80%+ market share by volume, though branded Eliquis holds premium pricing.[4]
How Have Sales Evolved Year-Over-Year?
Eliquis sales peaked at $12.2 billion in 2022. U.S. revenue dropped to $6.7 billion in 2023 (45% decline) as generics launched, then stabilized at $6.1 billion in 2024 despite further erosion. Global sales fell to $10.4 billion in 2023, with Q4 2024 U.S. figures at $1.4 billion quarterly.[1][5]
Generics undercut prices by 70-90%, shifting volume but squeezing branded revenue. BMS/Pfizer forecast 2025 U.S. sales around $5 billion, cushioned by international branded demand.
What Drives Market Share Losses?
Generics captured 90%+ of U.S. prescriptions within months of launch due to payer incentives and identical efficacy. Branded Eliquis retains ~15-20% share via patient assistance and copay cards, but volume scripts plummeted 75% post-entry.[3][6]
Litigation delayed some ANDAs, but Paragraph IV settlements accelerated access. Overseas, slower uptake in Asia sustains branded sales.
How Does Apixaban Compare to Competitors?
| Drug | Maker | 2023 Global Sales | Patent Cliff | Key Edge Over Apixaban |
|------|--------|-------------------|--------------|-----------------------|
| Eliquis (apixaban) | BMS/Pfizer | $10.4B | 2027 U.S. | Lowest bleeding risk among DOACs |
| Xarelto (rivaroxaban) | J&J/Bayer | $7.5B | 2024 U.S./ongoing EU fights | Once-daily dosing |
| Pradaxa (dabigatran) | Boehringer | $1.2B | Expired 2020+ | Reversible anticoagulant |
| Savaysa (edoxaban) | Daiichi | $0.8B | 2031+ | Fast onset |
Apixaban leads DOACs with superior safety profile in trials like ARISTOTLE, holding 45% U.S. market pre-generic vs. Xarelto's 30%. Post-cliff, generics erode this while competitors face their own pressures.[4][7]
What Are Revenue Forecasts and Risks Ahead?
Analysts project Eliquis global sales at $8-9 billion in 2025, dropping to $4-5 billion by 2028 as U.S. generics mature. Upside from emerging markets; downside from further ANDA approvals or trial losses (e.g., ongoing patent suits).5
Risks include supply chain issues for generics, potential BMS evergreening wins extending exclusivity, or shifts to cheaper warfarin. BMS offsets via Opdivo growth, but Eliquis decline cuts ~20% from its revenue base.
Sources
[1]: https://investor.bms.com (BMS 2024 10-K)
[2]: https://www.drugpatentwatch.com/p/tradename/ELIQUIS (DrugPatentWatch)
[3]: https://www.fda.gov/drugs (ANDA approvals)
[4]: https://www.iqvia.com (MIDAS market data 2024)
[5]: https://www.pfizer.com/investors (Pfizer Q4 2024 earnings)
[6]: https://www.symphonyhealth.com (prescription data)
[7]: NEJM ARISTOTLE trial (2011)