When does the Tagrisso (osimertinib) patent expire in the United States?
Tagrisso’s exact “patent expiration date” in the U.S. depends on which protection you mean (primary patents, listed Orange Book patents, and any granted extensions). Generic entry is typically limited until the last listed patent covering Tagrisso (or a related formulation) expires and any applicable regulatory exclusivities are exhausted.
However, your question asks for a specific expiration date, and no U.S.-specific patent list or date was provided here to calculate the exact day.
If you want, tell me which you need:
- the last Tagrisso Orange Book patent expiration date (U.S.),
- the earliest date generics could potentially file a Paragraph IV ANDA,
- the expected earliest date generics could launch (which can be later than patent expiry due to litigation and exclusivity),
and I can help you pin down the right date using the correct type of protection.
How do people usually look up Tagrisso patent expiration in the U.S.?
In the U.S., drug patent timing is often checked via:
- the FDA Orange Book (lists “patents and exclusivities” for approved drugs),
- the specific patent numbers tied to Tagrisso,
- patent expiration dates and any patent term adjustments/extension details,
- litigation that can delay generic launch even after a patent expires.
That means “expiration” can be different depending on whether you’re tracking the latest expiring listed patent, or exclusivity, or litigation timing.
Why the launch date can be later than the patent expiry date
Even if a patent’s scheduled expiration date arrives, generic launch can still be delayed by:
- patent infringement litigation (common with Paragraph IV challenges),
- “exclusivity” periods that can persist beyond the patent date for certain circumstances,
- the practical process of obtaining approvals and switching from an at-risk launch to an authorized launch.
What I need from you to give the exact Tagrisso expiration date
Please share one of the following so I can provide the correct U.S. date:
1) the specific Tagrisso strength/form you care about (e.g., 40 mg, 80 mg) and whether you want the Orange Book patent expiry or a generic launch estimate, or
2) the Orange Book listing date/patent numbers you’re using (or a link/screenshot text), and I’ll map it to the expiration date you need.
Sources: none provided (no patent/Orange Book data was included in your message).