See the DrugPatentWatch profile for brodalumab
When does brodalumab lose patent protection and exclusivity?
Brodalumab (marketed as Kyntheum) had an initial compound patent filing in the late 2000s, with additional patent filings and family members that can extend coverage in different jurisdictions. Patent “expiration” therefore depends on the specific country and the exact patent(s) covering the product in that market, plus any patent-term adjustments or supplementary protection mechanisms that apply locally.
However, the provided information here does not include the specific patent numbers, jurisdiction(s), or the date you need (e.g., “first launch country,” “EU vs. US,” or “expiry of marketing exclusivity vs. patent exclusivity”). Without those details, there is no single correct date to state.
Does brodalumab have marketing exclusivity (not just patents)?
Yes, many countries provide some form of marketing or regulatory exclusivity that can delay generic entry even after relevant patents expire (or in parallel with patent coverage). The exact length and trigger for “exclusivity” differs by regulator (for example, US Hatch-Waxman exclusivity vs. EU/EMA mechanisms).
The provided information does not specify which exclusivity regime you mean (regulatory exclusivity vs. patent term) or which country you’re targeting, so I can’t accurately give a timeline.
What country matters most for brodalumab exclusivity dates?
Exclusivity timing varies by jurisdiction:
- In the US, generic timing depends on Orange Book-listed patents and any relevant exclusivity periods.
- In the EU, timing depends on the national implementation of supplementary protection mechanisms and any data/exclusivity protections tied to authorization.
- In the UK and other markets, local patent term and regulatory exclusivity rules change the effective date.
If you tell me the country (US, EU5, UK, etc.) and whether you want “patent expiry” or “regulatory exclusivity,” I can narrow to the right type of date.
What’s the difference between “patent exclusivity” and “generic entry” for brodalumab?
Even if a patent expires, generic or biosimilar launch can still be blocked by:
- remaining patents in the same family (formulations, dosing regimens, specific molecules/processes),
- other unexpired patents listed for the product in that jurisdiction,
- regulatory exclusivity protections,
- or ongoing litigation (where a court stays/blocks market entry while disputes resolve).
So the practical “earliest entry” date is often later than the first patent expiration.
If you’re looking for a biosimilar/biogeneric timeline, what should you check?
For monoclonal antibodies like brodalumab, you typically check:
- the biosimilar pathway eligibility and reference product status,
- which patents are listed for the reference product and whether any are still in force,
- any regulatory exclusivity that limits biosimilar approval or launch,
- and whether settlement agreements affect launch timing.
Again, the exact date depends on jurisdiction and the patent list for that jurisdiction.
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What I need to answer with exact dates
Reply with:
1) Which market: US, EU (and which countries), UK, Canada, or “global”?
2) Which date you want: first patent expiry, last patent expiry, or earliest possible generic/biosimilar entry?
With that, I can give a precise exclusivity timeline for brodalumab in the right jurisdiction.