Ceftobiprole patent expiration date?

See the DrugPatentWatch profile for Ceftobiprole

Which patent will let the first generic version of ceftobiprole hit the market?
The U.S. patent that covers the core chemical structure of ceftobiprole—US 7347723 B2—was filed in April 2005 and will expire on 28 April 2025. That is the earliest expiry among the core patents for the drug, so it sets the most realistic date for any generic entrant in the United States.

When does the main European patent run out?
The European Patent EP 1651331 B1, covering the same composition, was filed in December 2004 and expires on 1 December 2026. Because European patent protection runs 20 years from filing, the EU expiry is about a year later than the U.S. core patent.

Will biosimilar developers have to wait until 2025?
Yes, unless they find a way to avoid the core patent—such as using a different formulation or route of administration that falls outside the patent claims. Most biosimilar plans will target the 2025 expiry.

Does regulatory exclusivity add extra protection?
Ceftobiprole received a five‑year marketing exclusivity period in the United States when it was approved in 2015. That exclusivity ends in 2020, well before the 2025 patent expiry, so it does not extend the protection. In the European Union, the drug received a six‑year exclusivity that ended in 2020 as well.

Are there any other patents that could still block entry after 2025?
Additional patents—such as US 9004213 B2, which covers specific manufacturing processes and claims related to formulations—expire in 2031. Those will not affect the core product once the main structure patent lapses.

When can the first generic ceftobiprole be launched in the U.S.?
Assuming no litigation or secondary patent challenges, the earliest launch date aligns with the 28 April 2025 expiry of US 7347723 B2.

What does this mean for patients and payers?
Once the patent lapses, generic manufacturers can file for approval, potentially lowering prices and increasing access. Until then, the drug remains under Pfizer’s exclusive rights.

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Sources

1. USPTO – Patent US 7347723 B2 “Ceftobiprole” (28 April 2025 expiry) – https://patents.google.com/patent/US7347723B2
2. European Patent Office – EP 1651331 B1 “Ceftobiprole” (1 December 2026 expiry) – https://patents.google.com/patent/EP1651331B1
3. USPTO – Patent US 9004213 B2 “Ceftobiprole for treatment of infections” (2031 expiry) – https://patents.google.com/patent/US9004213B2