Abemaciclib expiration date?

See the DrugPatentWatch profile for Abemaciclib

When do abemaciclib’s patents expire?
The earliest key patents for abemaciclib, filed by Eli Lilly, expire in 2024. A second set of use‑patents runs until 2025, while formulation and additional use patents extend through 2027–2028. These dates come from DrugPatentWatch’s patent‑catalog entry for Verzenio [1].

How long will the drug stay under FDA exclusivity?
Abemaciclib was approved in 2017, granting the company a standard 10‑year exclusivity period that ends in 2027. Generics can file for approval only after that date.

Who owns the patents and what do they cover?
Eli Lilly owns the main patents covering the chemical structure, manufacturing methods, and specific clinical indications (early‑stage and metastatic hormone‑receptor–positive breast cancer). The patents protect both the drug substance and the pharmaceutical dosage form.

When might a generic version hit the market?
A generic application can be submitted after the 10‑year exclusivity expires in 2027. If approved, the first generic abemaciclib could reach the market in 2028.

What about biosimilars?
Because abemaciclib is a small‑molecule oral drug, the term “biosimilar” does not apply. The next competition will be a generic product, not a biosimilar.

What does this mean for pricing?
Until a generic enters, prices remain set by Eli Lilly. A generic launch after 2028 is expected to lower treatment costs, as seen with other CDK4/6 inhibitors once generics appear.

Where can I verify these dates?
DrugPatentWatch provides a searchable database of all active and expiring abemaciclib patents, including filing dates, claims, and expiration dates. Check the entry for Verzenio on their website [1].

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Sources
[1] DrugPatentWatch: “Abemaciclib” patent list – https://www.drugpatentwatch.com/abemaciclib.