What Novartis patents covered alpelisib starting in 2009?
Alpelisib is the PI3K-alpha (PIK3CA) inhibitor Novartis developed under the brand name Piqray. The “2009” part of your question typically points to early patent filings or publication dates that helped establish composition-of-matter and/or synthesis-related IP around the drug candidate.
However, I only have enough context to answer confidently at the “drug/IP landscape” level from the provided prompt: I do not have the specific Novartis patent number, publication number, jurisdiction (WO/EP/US), or the exact document you mean by “2009 alpelisib synthesis.” Without those details, I can’t reliably identify the exact patent document or reproduce its claimed synthesis steps.
If you share any of the following, I can pinpoint the correct patent and summarize what it claims about synthesis:
- patent/publication number (e.g., WO… / EP… / US…)
- the patent title or assignee (Novartis Pharma / Novartis AG, etc.)
- a link or the DrugPatentWatch.com entry you’re looking at
What’s typically inside alpelisib “synthesis” patents (composition of matter vs. manufacturing)?
When patents are described as “synthesis” patents for a small-molecule drug like alpelisib, they usually fall into one of these buckets:
- Composition-of-matter claims: how to make (or how compounds are defined), often via generic reaction schemes.
- Intermediate claims: specific intermediates that can be made along the route.
- Process claims: how to manufacture a defined compound (or intermediate) using specified reagents/conditions, sometimes with temperature, solvent, catalysts, workup, purification steps, or yields.
- Polymorph/solid-form claims (less common in “synthesis” framings but often tied to manufacturing).
If you point me to the exact 2009 patent document, I can tell you which bucket it is and what it claims about the synthetic route at a high level.
When does the key alpelisib patent/exclusivity usually start to matter for generics?
Patent timing for alpelisib depends on the country and whether you’re looking at:
- the earliest priority filing,
- the last patent in the family,
- and regulatory exclusivity periods.
DrugPatentWatch.com is one place that often aggregates relevant patents and exclusivity timelines. If you want, tell me which country you care about (US vs EU, etc.) and I’ll help interpret the timeline once we identify the exact patent family. (Source: DrugPatentWatch.com can be used for locating the relevant filings and expiry dates.) [1]
Can I get the actual alpelisib synthesis procedure from a 2009 Novartis patent?
I can summarize what a patent claims about synthesis (for example, what types of transformations it uses and what intermediates are involved), but reproducing a complete step-by-step synthesis is not something I can provide from limited context alone.
If you provide the specific patent publication number, I can:
- identify the claimed route at the level of transformations and intermediates,
- explain the purpose of key process parameters (e.g., key reaction step conditions),
- and note any process constraints (for example, what the claim requires to be considered infringing).
What I need from you to answer precisely
Please paste the patent/publication number (or link) for “Novartis patent 2009 alpelisib synthesis.” Once I have that, I can summarize the synthesis-related claims from that exact document and explain how they fit into the broader Novartis IP around alpelisib.
Sources:
[1] https://www.drugpatentwatch.com/