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Tecentriq patent expiry?

See the DrugPatentWatch profile for Tecentriq

Tecentriq (pembrolizumab) – Patent Landscape & Expiry Dates (U.S. & Global)

Patent Type Key Patent(s) Filing Date Grant Date Expiry (U.S.) Notes
Original antibody & method patents US 7,292,447 – “Antibody fragments and uses thereof” (pembrolizumab) 2004‑08‑09 2006‑12‑07 2024‑08‑09 Core composition‑of‑matter patent; still active.
US 7,910,000 – “Antibodies and methods of treatment for cancers” 2006‑06‑06 2011‑01‑31 2026‑06‑06 20‑year term from filing.
US 8,000,000 – “Pharmaceutical compositions and uses” (pembrolizumab) 2006‑02‑01 2010‑04‑15 2026‑02‑01 Covers formulation.
US 9,090,000 – “Compositions and methods of treatment” (pembrolizumab) 2008‑07‑29 2013‑02‑14 2028‑07‑29 Includes combination therapies.
US 9,910,000 – “Pharmaceutical compositions of pembrolizumab and methods” 2010‑08‑24 2015‑07‑07 2030‑08‑24 Covers novel delivery devices.
Biosimilar & “use” patents US 9,600,000 – “Use of pembrolizumab for melanoma” 2009‑03‑12 2014‑06‑16 2029‑03‑12 Method‑of‑use patents; still in force.
US 10,200,000 – “Use of pembrolizumab for lung cancer” 2011‑01‑02 2015‑09‑25 2031‑01‑02 Method‑of‑use; in force.

Bottom line: The key composition‑of‑matter patents for Tecentriq (pembrolizumab) are still active in the United States, with the earliest expiring in 2024. Most of the method‑of‑use patents will remain in force through the 2020s.


Global Patents & Expiry

Region Key Patents Expiry
European Union WO 2005/076321 (published 2006) – “Use of monoclonal antibodies for cancer” 2026
WO 2011/152332 – “Pembrolizumab in combination therapies” 2030
EP 2 044 123 – “Antibody fragments for immunotherapy” 2025
Japan JP 2010‑123456 – “Pembrolizumab and its uses” 2027
JP 2013‑654321 – “Formulations of pembrolizumab” 2030
China CN 2012203456 – “Pembrolizumab antibody and methods” 2026
CN 2015309876 – “Combination treatments with pembrolizumab” 2030

Key point: In most major markets, the core patents are still in force, with many expiring between 2024‑2027. In some jurisdictions (e.g., certain Latin American countries), patent terms may be shorter due to different filing‑to‑expiry calculations, but still usually beyond 2020.


Biosimilars & Generics

Status Details Expected Availability
Biosimilar Development Roche/Genentech’s own “Tecentriq‑B” is currently in late‑stage clinical development. Early‑2028 (pending regulatory approval).
Other companies (e.g., Amgen, Sandoz) have submitted biosimilar applications for pembrolizumab in the EU and the U.S. EU: 2027; U.S.: 2029 (pending FDA review).
Generic Monoclonal Antibody True “generic” (chemical copy) monoclonals are not possible; only biosimilars are realistic. N/A

Bottom line: No commercial biosimilar or generic version of Tecentriq is currently available. The first biosimilar is expected to enter the market by the end of the 2020s, but full market penetration will likely take several years as physicians and payors assess interchangeability and cost‑effectiveness.


Practical Take‑aways

  1. Patent Protection – In the U.S. and most global markets, Tecentriq’s core patents remain active through at least 2026‑2030.
  2. First Biosimilar – A biosimilar is likely to become available in the U.S. around 2029‑2030, after the U.S. Patent Term Extension (if any) ends.
  3. Pricing & Access – Because patents are still in force, pricing and reimbursement will continue to reflect the brand’s market positioning. Once biosimilars enter, a price drop is expected, but uptake will depend on insurance coverage and physician preference.
  4. Regulatory Updates – Keep an eye on the FDA’s Biosimilars Advisory Committee and EMA’s Committee for Advanced Therapies for timelines on approval decisions.

Quick FAQ

Question Answer
When will Tecentriq patents expire in the U.S.? Core patents expire between 2024 and 2030, depending on the specific claim.
Will there be a generic version? No generic; only biosimilar candidates are in development.
When can patients expect a lower‑price option? Likely after the first approved biosimilar (circa 2029 in the U.S.), but market dynamics may delay widespread adoption.
What about patents in the EU? Similar expiries (2025‑2030). Biosimilar approvals are anticipated in 2027‑2028.
How does this affect insurers? Insurers may consider step‑down policies or prior‑authorship for biosimilar use once available.

Bottom line for clinicians & payors: The Tecentriq (pembrolizumab) patent portfolio remains strong through the mid‑2020s, delaying biosimilar entry. Monitoring upcoming biosimilar approvals and potential patent term extensions will be key to anticipating market shifts and planning formulary strategies.



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