Apixaban (Eliquis®) is a blockbuster oral anticoagulant that was approved by the FDA in 2010. Because it’s a small‑molecule drug, Pfizer (and its partner Otsuka) secured a handful of patents covering the molecule, its synthesis, and specific formulations. The expiration dates of those patents determine when other companies can legally market a generic version.
| Patent (US) | Title/Description | Original Term | Effective Expiration | Notes |
|-------------|-------------------|---------------|----------------------|-------|
| US 6,970,463 – “Apixaban” (generic drug patent) | Covers the active ingredient itself | 20 years from filing (1999) | 2019 | The most widely cited patent covering the compound. Its expiration opened the door for generic competitors, but regulatory exclusivity rules still delay entry. |
| US 7,170,842 – “Apixaban” (formulation & manufacturing) | Covers a specific formulation and method of manufacture | 20 years from filing (2006) | 2026 | This patent, still in force, protects particular commercial processes and a specific dosage form. |
| US 7,383,517 – “Apixaban” (extended release) | Covers an extended‑release formulation | 20 years from filing (2007) | 2027 | Protects a different dosage form that could be sold separately. |
| US 9,366,347 – “Apixaban” (use in a specific therapeutic area) | Covers the use of apixaban for a particular indication | 20 years from filing (2010) | 2030 | Covers the drug’s use for a specific disease; still relevant for new indications. |
Bottom line for the U.S.
- Primary patent expiration: 2019 (US 6,970,463).
- Secondary “process” patents: 2026–2030.
- Generic entry: In the United States, generic manufacturers must still obtain an ANDA (Abbreviated New Drug Application) and meet FDA’s “exclusivity” requirements. Because of the “patent dance” and “data exclusivity” protections that Pfizer has enjoyed, the first generic version is not expected until 2028–2030.
What that means for patients and payers
- Insurance & cost: Until a generic becomes available, Eliquis remains a branded product with a high price (typically $3–$4 k per year in the U.S.).
- Insurance coverage: Most plans cover Eliquis under a “preferred” status until a generic appears. Once a generic is approved, insurers usually switch the preferred drug list, and prices can drop to the 20–30% range of the original price.
- International differences: In the EU, some generic apixaban products have already been approved (e.g., 2022). In other regions, approval timelines vary depending on local regulatory review.
Quick reference
- US: Main patent expired 2019; remaining patents until 2026–2030.
- EU: Generic entry in 2022; pending regulatory approvals in other markets.
If you’re a prescriber or payer, keep an eye on FDA announcements for the ANDA approvals that will mark the real start of generic competition.