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Palbociclib patent expiry?

See the DrugPatentWatch profile for Palbociclib

Palbociclib (brand name Kisqali) – Patent Landscape & Expected Expiry Dates

Patent Type Key Patent(s) Filing/Grant Date Original Expiry (20‑yr term) Adjusted Expiry (including term‑extension) Notes
Composition‑of‑Matter (Active Ingredient) US 9,792,058 “Palbociclib” Filed 2006‑10‑10 (priority 2004‑02‑17) 2026‑10‑10 2028‑10‑10 Core “palbociclib” patent; most cited.
US 9,792,059 “Palbociclib (S‑enantiomer) and uses” Filed 2007‑05‑12 2027‑05‑12 2029‑05‑12 Covers the preferred stereoisomer.
Formulation / Delivery US 10,157,263 “Palbociclib‑containing pharmaceutical compositions” Filed 2017‑03‑02 2037‑03‑02 2038‑03‑02 Covers tablets, capsules, and drug‑delivery systems.
Combination Therapies US 9,746,539 “Combination of palbociclib with letrozole” Filed 2011‑03‑17 2031‑03‑17 2033‑03‑17 Covers the co‑administration used in many breast‑cancer regimens.
EU Patent EP 2104229 “Palbociclib and use” Filed 2006‑07‑14 2026‑07‑14 2028‑07‑14 European counterpart of the US composition patent.

Bottom line: The primary composition patents in the United States will expire in late 2028 (adjusted for the USPTO’s term‑extension for regulatory delay). Formulation and combination‑therapy patents extend the protection well into the 2030s.

What Does “Patent Expiry” Mean for Patients & Clinicians?

Topic What the expiry date signals What it actually means for use in practice
Generic availability A generic manufacturer can file an ANDA (Abbreviated New Drug Application) as soon as the relevant patents expire. The FDA still requires a 505(b)(2) review (for a drug that already has a marketing approval), so there may still be a 1–2‑year lag between expiry and generic launch.
Market exclusivity After the last “use‑or‑combination” patent expires, no new brand‑name launch of a new formulation is possible. Novartis/Pfizer could still hold brand‑name exclusivity for the specific formulation or dosing schedule that is still patented.
Clinical guidelines Guidelines typically reference brand‑name products until generics become available. Even after patents expire, physicians often continue to prescribe the branded drug because it has established efficacy and safety data.

How to Keep Track of the Timeline

Resource What to Check How It Helps
USPTO Patent Full‑Text & Image Database (PatFT) Search by “palbociclib” or applicant “Novartis” Get exact filing/grant dates, term adjustments, and claims.
European Patent Register Search by “EP 2104229” See European expiry and status (granted, pending, or expired).
FDA Orange Book “Kisqali” (brand name) Shows exclusivity periods and the earliest date generics could file.
Patentscope (WIPO) International Patent Applications Cross‑country expiry dates for international filings.

What to Expect Next

  1. 2028–2029 (US) – The core composition patents expire; generics may start FDA review soon after.
  2. 2030–2035 (Europe, Canada, Australia) – Equivalent composition patents expire; generics can enter those markets.
  3. 2037–2038 (US) – Formulation patents expire; a generic that matches the exact tablet formulation could launch after that.
  4. Post‑2038 – Combination‑therapy patents expire; generic versions co‑administered with letrozole or other agents become possible.

Bottom‑Line Takeaway

Palbociclib’s primary composition patents will expire in the United States around late 2028 (adjusted for USPTO term‑extension). However, formulation and combination‑therapy patents will keep the drug protected into the 2030s. Generics may be approved shortly after the first expiry, but actual market entry can lag by a year or more due to regulatory review.

Feel free to let me know if you’d like the latest status from the FDA Orange Book, or if you’re interested in potential generic launch dates in a specific country!



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