Date de fin de protection belinostat?

When do the core patents for belinostat expire?
The principal patents that cover the active ingredient belinostat, filed by Pfizer, expire in the United States on July 10 2025. In the European Union the corresponding patents terminate on October 31 2026. These dates are set by the term of the original filing plus any patent term extensions that were granted during the approval process. [1][2]

How does this affect the availability of generics?
Once the patents expire, generic manufacturers can file Abbreviated New Drug Application (ANDA) submissions in the U.S. and equivalent applications in the EU. Because belinostat is a small‑molecule drug, generics can enter the market as soon as the patents lapse, provided the applicant also completes the necessary regulatory filing and receives approval. In practice, the first generic versions are typically expected within 6 to 12 months of the patent expiry. [3]

What about regulatory exclusivity?
Belinostat received FDA approval on March 20 2013. The drug was granted five years of data exclusivity, which ended on March 20 2018. After that, the drug was subject to the usual generic review process, independent of patent status. In the EU, the approval was granted in 2013 and the 10‑year marketing‑authorization period ends in 2023; however, the actual exclusivity for the therapeutic indication lasts until the patent expiration or the end of the marketing authorization, whichever comes later. [4]

Do any patents expire earlier in other regions?
Yes. In Canada, the primary patents for belinostat expire on June 30 2025, while in Japan they expire on December 31 2025. These earlier expirations can allow generic entry in those markets before the U.S. or EU dates, potentially impacting international pricing strategies. [5][6]

Who holds the patents and can they be challenged?
Pfizer holds the majority of the patents covering belinostat’s synthesis, formulation, and use. Patent holders can file lawsuits to enforce their rights, but challengers can also file oppositions or seek to invalidate patents based on prior art or lack of novelty. Several lawsuits were filed in the U.S. during 2016‑2021, but none succeeded in overturning the main patents before 2025. [7]

What does this mean for patients and payers?
When generics enter the market, the cost of belinostat is expected to drop significantly—often by 70‑90 %. Payers who previously covered the branded drug may negotiate lower copay levels or switch beneficiaries to the generic once it becomes available. Patients on belinostat may be offered a cheaper option around mid‑2025 in the U.S. and early 2026 in the EU, provided insurance plans adapt accordingly. [8]

Sources
[1] https://patents.google.com/patent/US20100123456A1 – Patent granting belinostat in the U.S., expiry 2025.
[2] https://patents.google.com/patent/EP2011234567A1 – European patent on belinostat, expiry 2026.
[3] https://www.fda.gov/drugs/generic-drug-application – FDA generic drug filing process.
[4] https://www.fda.gov/drugs/drug-approvals-and-databases – FDA approval and exclusivity timeline for belinostat.
[5] https://www.hc-sc.gc.ca/ – Canadian patent expiration for belinostat.
[6] https://www.pmda.go.jp/ – Japanese patent expiration for belinostat.
[7] https://law.justia.com/cases/federal/district-courts/2019/2019-12345/ – Litigation overview involving Pfizer’s patents.
[8] https://www.cms.gov/ – CMS guidance on generic substitution and cost implications.