When Does Tagrisso Patent Expire?

Tagrisso still has substantial patent life remaining. The earliest expiration is 2032 — 6.0 years out — and the full portfolio runs to 2042. That is comfortably outside the standard window for ANDA filings, but pre-approved biosimilar developers often begin clinical equivalence work 6 to 8 years before composition expiry.

Because Tagrisso's earliest patent expiry is more than three years out, generic competition is not imminent. ANDA filings can occur as early as four years after NDA approval (the so-called "5-year exclusivity wall"), but actual market entry is gated by the latest unexpired patent. For clinicians and payers, the planning horizon for generic substitution on Tagrisso is 2032 at the earliest.

For the authoritative listing of patents tied to a specific drug — the patents an ANDA filer is legally required to address under 21 USC § 355(j) — consult the FDA Orange Book. Underlying utility patent data on this page is sourced from USPTO PatentsView, the federal government's free public patent API.

Tagrisso is protected by 5 US patents, a mid-sized portfolio that is typical for an established branded drug in mid-lifecycle. The portfolio likely combines a primary composition-of-matter patent (the strongest form of protection) with a layer of formulation, dosing, and method-of-use patents that extend exclusivity beyond the original composition expiry — a common strategy known as "patent layering" or, less charitably, "evergreening."

All 5 patents in the Tagrisso portfolio are assigned to AstraZeneca AB, indicating consolidated ownership. Single-assignee portfolios are simpler to litigate and easier to license — generic challengers face one negotiating counterparty, and any settlement or pay-for-delay arrangement involves only that holder.

The Tagrisso portfolio scores 70/100 (Grade B, "strong") on the PatentCliff Strength index. The strongest signal is time remaining until expiration (100/100), and the weakest is portfolio size (60/100). The four factors are weighted by how well they predict real-world resilience to generic challenge: portfolio size 30%, claims breadth 25%, time remaining 25%, and technology diversity 20%.

Looking at the 5 dated patents in the portfolio, the largest cluster (4 patents) falls in the "5–10 years (2032–2036)" bucket. That distribution matters because generic entry is gated by the latest unexpired blocking patent, not the earliest — even one late-expiring formulation patent can delay biosimilar launch by years if it survives a Paragraph IV challenge.

The 20-year patent term in the United States runs from the earliest non-provisional filing date, not the grant date. That means a patent granted in 2015 from a 2010 filing has only 15 years of life left at grant — a feature of US patent law that creates the layered "cliff" pattern visible in most branded drug portfolios. Patent Term Extension under 35 USC § 156 can add up to 5 years for time lost to FDA review, and pediatric exclusivity can add 6 months on top.