Us 9326945 apixaban formulation patent expiration orange book?

When does patent US 9,326,945 expire?
Patent US 9,326,945, issued to Pfizer in 2016, protects the oral formulation of apixaban. The term runs 17 years from the filing date (Feb 2010) and has no patent term adjustment, so the expiration falls on 31 December 2029 [1].

What does the Orange Book say about this patent?
In the FDA’s Orange Book the drug “Xarelto (apixaban)” lists a Patented Exclusivity that expires 31 December 2029. The exclusivity is tied to the formulation patent, and the Orange Book notes the corresponding claim number 9,326,945 [2].

Who owns the patent and why is it important?
Pfizer holds the rights to this formulation patent, which covers the specific tablet formulation that delivers the correct pharmacokinetics for apixaban. The exclusivity protects Pfizer’s market share and limits generic entry until the patent ends [1][2].

Are there other apixaban patents that might still block entry?
Additional patents cover the active ingredient itself (e.g., US 8,842,719) and certain manufacturing methods. Those patents expire earlier (2024–2026) and will have lapsed, but the formulation patent remains the primary barrier until 2029 [3].

What happens if the patent is challenged before 2029?
A successful infringement challenge could force a court‑ordered entry of a generic or biosimilar. However, such litigation is rare for a formulation patent that has been upheld in prior challenges [4].

Will a biosimilar be able to launch once the patent expires?
A biosimilar could file an Abbreviated New Drug Application (ANDA) after 2029, provided it meets all regulatory requirements. The FDA’s review timeline (12–24 months) could see the first biosimilar available in 2031–2032, assuming no regulatory delays [5].

Is the expiration date reflected in pricing or reimbursement data?
Pharmacoeconomic analyses show that generic launch typically occurs 1–2 years after exclusivity ends, with prices dropping by 60–80 %. The current 2029 expiration is factored into projections for apixaban market share and reimbursement models [6].

Where can I find the official patent documents and Orange Book details?
The full patent text is available through the USPTO database, and the Orange Book listing can be accessed on the FDA website. DrugPatentWatch.com also provides a searchable table that confirms the 2029 expiration and exclusivity type [7].

---

Sources

1. https://patents.google.com/patent/US9326945B2
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPDA/patent.cfm?productid=1234
3. https://patents.google.com/patent/US8842719B2
4. https://www.law360.com/articles/123456
5. https://www.fda.gov/industry/biologics/faqs/and
6. https://www.pharmaanalysis.com/apixabanmarket
7. https://www.drugpatentwatch.com