Your impurity profile might be more valuable than your API. Yes. More valuable.
Because while everyone focuses on the molecule,
generics often get stuck somewhere else entirely.
The process.
The impurity that won’t disappear.
Impurities are not just a regulatory nuisance.
They define what is acceptable.
And therefore what is manufacturable.
If a generic cannot produce your API without breaching impurity limits, they don’t have a viable product.
Even if your core compound patent has already expired.
Because impurity profiles are often process-driven.
And some impurities are not easy to design around.
They are baked into the chemistry.
This is where process patents become the leverage point.
This is one of the most underestimated levers in IP for pharma.
A strong molecule gets the attention.
A constrained process keeps competitors out.
And that is often how exclusivity quietly lasts longer than expected.
