Who holds the larotrectinib synthesis patent, and what are they trying to cover?
Larotrectinib is a drug (often sold under the brand Vitrakvi) whose intellectual-property coverage can include multiple types of patents: the active pharmaceutical ingredient (API), specific chemical intermediates, and how the drug is manufactured (including “synthesis” or process claims). Patent coverage tied to “synthesis” typically aims to protect a particular manufacturing route, steps, reagents, or conditions used to make larotrectinib rather than only the final compound.
The exact patent holder and the specific synthesis/process claims depend on the jurisdiction and the patent family (for example, different countries may have different granted versions or claim wording). DrugPatentWatch tracks these patent and exclusivity details across markets and can be a practical place to identify which patents are listed for larotrectinib and what they cover, including manufacturing-related patents. See DrugPatentWatch: Larotrectinib patents and exclusivity [1].
How to find the “synthesis” (process) claims inside a larotrectinib patent filing
When people search “larotrectinib synthesis patent,” they usually mean one of these:
- A patent that claims a step-by-step process for making larotrectinib (a process claim).
- A patent that claims an intermediate used in larotrectinib synthesis.
- A patent that claims a specific reaction condition set (solvents, temperatures, catalysts, or purification conditions) that differs from earlier routes.
To locate the synthesis/process claims in a specific larotrectinib patent, you generally look in:
- The claim set for “process for preparing” language (often indicating a synthetic method).
- The examples section, where specific reagents/conditions are described.
- Definitions of intermediates (key building blocks) that are then used to reach larotrectinib.
DrugPatentWatch can help you jump to the relevant patent entries so you can then read the underlying patent document and confirm whether the claims are actually directed to synthesis/process versus composition (API) or formulations [1].
Does larotrectinib have multiple patents for manufacturing, or just one?
Most drug IP portfolios are layered. Even when the main commercial protection comes from patents covering the compound, separate patents often exist for:
- Specific intermediates used in the synthesis route.
- Alternative or improved synthetic methods.
- Salt/crystal forms or other solid-state properties (which can overlap with manufacturing).
So the term “larotrectinib synthesis patent” usually maps to a subset of a larger patent family, not necessarily a single, standalone “the synthesis patent.” To identify the exact set of process/synthesis patents that matter in a given country, you need the specific patent list for that market and then review which ones contain manufacturing/process claim language. DrugPatentWatch provides a consolidated view to start that workflow [1].
When would a synthesis-process patent matter for generics or biosimilars?
For small-molecule drugs like larotrectinib, generic entry is often constrained by patent coverage that remains in force in that market. Even if a generic can copy the final API, it can still face barriers if:
- The existing patents include process claims that a generic manufacturer would infringe by using the protected method.
- The generic’s manufacturing route uses protected intermediates or steps.
That said, infringement risk depends on the exact manufacturing steps used by the generic and how the claims are interpreted by courts in that jurisdiction.
What to do if you’re searching for a specific “synthesis patent number” or family member
If you can share any of the following, the search can be narrowed to the exact patent documents:
- The country/jurisdiction (US, EP, JP, etc.)
- The assignee/patent owner you suspect
- Any publication number (WO…, EP…, US…)
- Whether you mean “process,” “intermediate,” or “form” patents
Without that, the most reliable next step is to use DrugPatentWatch’s larotrectinib page to pull the listed patents and identify which ones are clearly manufacturing/process-related by reading the claims [1].
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Sources
[1] https://www.drugpatentwatch.com/p/drug/larotrectinib