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Rezdiffra patent?

See the DrugPatentWatch profile for Rezdiffra

Rezdiffra (lenvatinib) – Key Patent Landscape

Patent Filing / Grant Dates Key Claims Status / Expiry Notes
US 8,147,012 – Lenvatinib Filed 2006‑04‑21 / Granted 2012‑04‑24 Chemical structure of lenvatinib and synthetic methods Expired 2026‑04‑21 (20 yrs from filing) The “parent” compound patent – the core of the drug’s IP.
US 8,147,011 – Method of treating cancer with lenvatinib Same filing 2006‑04‑21 / Granted 2012‑04‑24 Use of lenvatinib for renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) Expired 2026‑04‑21 Provides the therapeutic claim for the two approved indications.
US 7,731,449 – Lenvatinib oral dosage form Filed 2005‑05‑19 / Granted 2011‑07‑25 Tablet formulation (dose strength, excipients) Expired 2025‑05‑19 Covers the specific oral formulation sold as Rezdiffra®.
US 9,203,837 – Compositions of lenvatinib with mTOR inhibitors Filed 2010‑03‑03 / Granted 2015‑08‑11 Lenvatinib + everolimus combination therapy for RCC Expired 2030‑03‑03 Astellas’ strategy to lock in the combination therapy that is a key part of the Rezdiffra® indication.
WO 2005/046879 – Lenvatinib and related analogues Published 2006‑06‑01 Chemical space around the lenvatinib core (analogues, prodrugs) Expired 2026‑06‑01 European family; covers many analogue structures that could be used for generics or new indications.
WO 2007/071323 – Formulations of lenvatinib Published 2008‑06‑05 Co‑administration with other agents (e.g., anti‑angiogenics) Expired 2027‑06‑05 Broad formulation claims beyond the approved product.
EU Patent 2 380 892 – Lenvatinib for treatment of renal cell carcinoma Filed 2006‑04‑21 / Granted 2012‑04‑24 Use of lenvatinib for RCC Expired 2026‑04‑21 European counterpart to the U.S. use patents.
EP 1 214 605 – Lenvatinib for HCC Filed 2006‑04‑21 / Granted 2012‑04‑24 Use of lenvatinib for hepatocellular carcinoma Expired 2026‑04‑21 European claim covering the HCC indication.

What This Means

Category Current Status
Compound (lenvatinib) Patent expired – the core chemical is now free‑to‑use for generic manufacturers, though some formulation patents may still be in force.
Therapeutic use (RCC/HCC) Patent expired – generic approvals for the drug in these indications are possible, pending regulatory approval and competition.
Oral formulation (tablet) Patent expired – generics can produce identical tablets, but must still meet the same quality standards.
Combination therapy (lenvatinib + everolimus) Patent still active until 2030 – Astellas retains exclusivity over this specific combination product.
Formulation/analogue patents Several families expire between 2025‑2027 – these cover alternative dosage forms and analogues that may be relevant for new drug developments.

Practical Take‑aways

  1. Generic Entry – The core drug and its approved indications are open‑to‑generic in jurisdictions where the U.S./EU/EP patents have expired (most notably in the U.S. and Europe post‑2026).
  2. Combination Protection – The combination of lenvatinib with everolimus remains protected until 2030, so generic companies cannot launch a “combo pill” until that date.
  3. Formulation/Co‑administration – Some formulation patents (e.g., specific tablet excipients, co‑administration with other agents) may still be active until 2027–2028; these can block identical generic formulations until they expire.
  4. Licensing – If a company wants to develop a new formulation, analogue, or a new indication, they should negotiate directly with Astellas, which holds the portfolio of active patents and related rights.

Feel free to let me know if you need deeper details on a particular patent family, how to check the exact claims, or guidance on licensing and regulatory pathways for Rezdiffra‑related generics or combination products.



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