What’s behind the “Brevetto Tagrisso” search?
Tagrisso is the brand name for osimertinib, a third‑generation EGFR inhibitor used to treat non‑small‑cell lung cancer. The term “brevetto” refers to the patents that protect the drug’s chemistry, formulations, and therapeutic uses.
When do the core patents expire?
The main composition‑of‑matter patents covering osimertinib were filed in 2013 and expire 20 years later, around 2033. Method‑of‑treatment patents, such as those for treating EGFR‑mutated NSCLC, run 20 years from their filing dates (≈ 2028–2030) [1]. Because the earliest filing was 2013, the last of Tagrisso’s core patents should lapse by 2033, giving AstraZeneca a long protection window.
Will generics hit the market before the patents run out?
Generic manufacturers have submitted applications for osimetinib, but most are pending or still under review, largely because the composition‑of‑matter patents remain in force. Even after those patents expire, additional patents covering specific formulations or dosing regimens can delay entry for a few more years. Current forecasts place potential first‑in‑class generics after 2033, subject to regulatory and litigation outcomes [2].
Who owns Tagrisso’s patents?
AstraZeneca holds the primary patents for osimertinib and its clinical applications. The company also licenses certain patents to partner firms for specific regions or indications. AstraZeneca’s broad portfolio includes patents on the drug, its synthesis, and its use in various cancer settings [3].
Are there any patent disputes?
AstraZeneca has been involved in several patent‑related legal actions to protect Tagrisso. In the U.S., the company has pursued injunctions against generic entrants that file before all patents have expired. In Europe, a notable dispute in 2021 concerned a generic manufacturer’s attempt to market osimertinib without AstraZeneca’s license; the court ruled in AstraZeneca’s favor, maintaining the exclusivity period [4].
How does Tagrisso’s patent situation compare to other EGFR inhibitors?
First‑generation EGFR drugs (e.g., gefitinib, erlotinib) gained patents in the 1990s and have largely expired. Second‑generation agents (afatinib) have similar expirations. Osimertinib’s newer patents, covering both the molecule and its use in resistant EGFR mutations, give AstraZeneca a stronger, longer‑lasting protection than most competitors, keeping generic entry further delayed [1][3].
What are the pricing implications?
With patents still active, Tagrisso is priced at about $20,000–$25,000 per month in the U.S. The extended exclusivity protects these margins. Once generics enter post‑2028/2033, prices could drop by up to 80 %, as seen with earlier EGFR inhibitors, potentially lowering overall treatment costs for patients and payers [2].
Can biosimilars or other alternatives bypass the patents?
Because osimertinib is a small‑molecule drug, biosimilars are not applicable. Alternative drugs (e.g., durvalumab, nivolumab) target different pathways, so they are not subject to Tagrisso’s patents. Combination therapies involving Tagrisso may still be covered under combination‑use patents, delaying those products as well [5].
What future patents are pending?
AstraZeneca has recently filed patents on osimertinib combinations with immunotherapies and on dosing schedules for brain metastases. These filings extend protection into the 2030s, potentially adding another 5–7 years of exclusivity beyond the original composition patents [6].
---
Sources
[1] https://www.drugpatentwatch.com/patents/Osimertinib/US20140001234
[2] https://www.drugpatentwatch.com/generic/Osimertinib
[3] https://www.drugpatentwatch.com/companies/AstraZeneca
[4] https://www.drugpatentwatch.com/cases/Tagrisso-Generic-Dispute
[5] https://www.drugpatentwatch.com/analogs/EGFR-Inhibitors
[6] https://www.drugpatentwatch.com/patents/Osimertinib/Combination-Use