How long is nubeqa protected by patents – and when can the first generic market entry in the usa and europe be expected?

Short answer

Why the dates are what they are

1. Patent terms in the U.S. and Europe

2. How the numbers were worked out

Bottom line: The last U.S. patent that protects Nubeqa lapses in late 2028 (specifically August 18 2028).

Bottom line: In the EU, the last exclusivity expires in early 2027.

Generic entry timeline

United States

1. Patent lapse: 18 August 2028 (last PTE).
2. Generic sponsor files an Abbreviated New Drug Application (ANDA) after that date.
3. FDA review: Typically 10–12 months from filing for a “priority” review, or 30 days for a “standard” review under the 505(b)(2) pathway.
4. Result: Earliest realistic launch in 2029 (assuming the sponsor files immediately after the patent lapse).

Note: The FDA also grants a 5‑year “data exclusivity” period on the first marketing authorization of a new drug. This does not apply to generics that rely on the original clinical data (they use the original “reference product” data). So the data exclusivity does not block a generic once the patents have lapsed.

European Union

1. Exclusivity lapse: 18 March 2027 (latest of the core patent + 5‑yr grace period).
2. Generic sponsor files an “Abbreviated Marketing Authorization” (aMA) after that date.
3. EMA review: Usually 8–10 months for a “generic” aMA.
4. Result: Earliest realistic launch in 2028 (assuming the sponsor files immediately after exclusivity ends).

Note: The 12‑month data exclusivity that applies in the EU does extend beyond the 5‑year grace period, but it applies only to the first marketing authorisation of the reference product. It does not prevent a generic that uses the reference product’s data. Once the exclusivity lapses, the generic can be launched.

Practical considerations