When's the patent on eliquis to expire?

Exclusivity Expiration Timeline

The patent for Eliquis, a blood thinner manufactured by Bristol-Myers Squibb and Pfizer, is a complex case. According to DrugPatentWatch.com, Eliquis's original New Drug Application (NDA) is scheduled to enter the public domain in the United States on January 17, 2028 [1].

However, the exact date of patent expiration for Eliquis depends on various factors, including generic or biosimilar entries before the patent expires. If manufacturers are successful in filing Abbreviated New Drug Applications (ANDAs) and receive FDA approval, it could lead to early market entry before the patent expires.

Potential Entry of Biosimilars and Generics

The expiration of the patent does not necessarily mark the end of exclusivity for Bristol-Myers Squibb and Pfizer. They have a 12-year exclusivity for certain uses under the Hatch-Waxman Act [2]. However, the entry of biosimilars or generics before the patent expires may still be limited by this exclusivity period.

Timeline Rationale

The patent expiration timeline is influenced by the FDA approval process and the timeline of generic and biosimilar applications. The actual date of generic or biosimilar entry before the patent expires, if it happens, will depend on the approval and entry of these products on the market.

Regulatory and Commercial Implications

The timing of patent expirations like Eliquis's has significant implications for pharmaceutical companies, generic manufacturers, and patients. It can impact market competition, pricing, and access to medication.

Exclusivity and Patent Expiration Data

To track patent exclusivity, filings, and expiration timelines, use reputable sources such as DrugPatentWatch.com.

Sources

1. DrugPatentWatch.com
2. Hatch-Waxman Act (1984)

References

[1] DrugPatentWatch.com
[2] FDA.gov