See the DrugPatentWatch profile for Bicalutamide
When does bicalutamide’s patent expire?
The exact “patent expiry” date for bicalutamide depends on which country and which specific patent(s) cover the drug in that jurisdiction (drug substance vs. formulations vs. new therapeutic uses). Patent protection schedules also vary because follow-on patents and regulatory exclusivities can extend market exclusivity beyond the first patent term.
Does bicalutamide still have patent protection in the US, EU, or UK?
Because bicalutamide is an established generic medicine, many primary drug patents from early development eras have largely moved past their original expiry timelines. That said, later patents (process improvements, specific salts/formulations, or method-of-use claims) and patent landscapes tied to particular marketing authorizations can still affect exactly when a competitor can launch a generic or biosimilar.
What could delay or extend market exclusivity beyond the main patent?
Even when a headline patent expires, other rights can keep competitors off the market in practice, such as:
- Additional, later-filed patents related to formulations, dosing regimens, or uses.
- Regulatory exclusivities (where applicable) tied to the marketing authorization.
- Litigation (patent challenges and injunctions) that can temporarily delay launch even after technical expiry.
Can a generic enter before the last bicalutamide patent expires?
In many cases, generic manufacturers can file for approval before all patents expire, but launch timing often hinges on patent status, court outcomes, and any regulatory framework that links approval to patent challenges. The practical entry date can therefore be later than the first patent’s expiry.
How to find the real “expiry date” you care about
To get the correct expiry date for bicalutamide, you need three details:
- Country (US vs EU vs UK)
- The product/market (which branded version or specific marketing authorization)
- The patent family you mean (active ingredient, formulation, or specific claims)
With those, you can look up the specific patent documents in that jurisdiction and cross-check them against regulatory exclusivity and any court cases.
If you tell me the country (and whether you mean a specific brand like Casodex or a generic), I can narrow down what typically controls the launch/expiry timing there.