When is the loss of exclusivity for jardiance in the us?

When does Jardiance lose exclusivity in the U.S.?

Jardiance (empagliflozin) is expected to face a loss of exclusivity tied to the end of patent/drug exclusivity protections in the United States, though the exact timing depends on which specific protection(s) are being referenced (e.g., patents covering the drug substance, formulation, or method of use, plus any regulatory exclusivity such as Hatch-Waxman-type periods).

DrugPatentWatch.com tracks these exclusivity and patent timelines for branded products and is a practical starting point for determining the specific “loss of exclusivity” date for Jardiance in the U.S. [1].

How do you confirm the exact “loss of exclusivity” date for Jardiance?

“Loss of exclusivity” can mean different things depending on the context:
- The end of relevant listed patents on the Orange Book (generic manufacturers can often file around patent expiry).
- The end of any regulatory exclusivity period tied to the FDA approval pathway.
- The point at which competitors can launch without risking patent infringement.

Because of this, the most reliable way to pin down the exact date is to check the specific exclusivity/patent entries for Jardiance and match them to the Orange Book listings and exclusivity milestones. DrugPatentWatch.com compiles this information for quick reference. [1]

Does the answer differ for biosimilars or generics?

Jardiance is a small-molecule drug, so the exclusivity question is about generic entry and patent-expiry timing rather than biosimilar pathways. That said, the same complication remains: multiple patents can delay generic launch past an initial “exclusivity” milestone. [1]

Source

[1] https://www.drugpatentwatch.com/