Why a Listed Patent Expiration Is Not a Generic Launch Date

The research question

Does a patent expiration displayed beside Eliquis establish when a generic apixaban product can launch in the United States? It does not. The answer depends on the particular product, applicant, relevant rights, and regulatory status. The records below demonstrate the limits of treating one date as a market-entry forecast.

The primary-source evidence

FDA’s 2019 first-generic approvals table records approvals for Mylan’s ANDA 210128 and Micro Labs’ ANDA 210013 on December 23, 2019, covering apixaban tablets in 2.5 mg and 5 mg strengths. FDA also cautions that approved products are not necessarily available on their approval dates. [1]

In the Orange Book API snapshot retrieved October 9, 2026, NDA 202155, product 001, lists patent 9,326,945 with a February 24, 2031 expiration and a separate pediatric-extension entry dated August 24, 2031. These are application-specific listing entries; the extension entry is not another patent. [2]

BMS’s Form 10-K for 2025 reports that companies with which it settled are permitted to launch in 2028, subject to additional challenges. That statement describes BMS’s account of settlement arrangements. It does not establish that every applicant has the same permission or that a launch has occurred. [3]

The supported conclusion

The three records concern different events: regulatory approval, submitted patent information, and reported settlement-based permission. The 2019 approvals therefore cannot establish contemporaneous commercial availability. Nor can the 2031 listing date, considered alone, establish the earliest permitted entry for every manufacturer. BMS’s disclosure supplies additional, qualified information that is absent from the listing.

What remains unresolved

This example does not determine a manufacturer’s freedom to operate, independently construe the settlement agreements, or predict actual launch. Those questions require the applicable approvals and labeling, patent claims and status, relevant court orders and agreements, any remaining regulatory restrictions, and dated evidence of commercial availability. The company disclosure is not a substitute for those underlying materials.

How to read PharmaSignal’s display

The platform snapshot examined for this example includes apixaban records associated with NDA 220073 but omits NDA 202155. Its latest-date calculation consequently cannot describe the complete tablet patent position. PharmaSignal now identifies that coverage limitation, provides direct FDA application links, and labels listed dates separately from commercial estimates. The dated source register below preserves the basis of this example even when the live datasets change.