What patents cover alpelisib (Piqray) and how does Novartis’ 2009 filing matter?
Alpelisib (Piqray) is tied to patent families held by Novartis for the compound and related formulations/uses. The “2009” reference typically comes from early filings in that family, which can include priority dates and subsequent continuation filings in different jurisdictions. Those later filings are what usually control when a specific patent (or set of patents) can expire, since legal status depends on each country’s prosecution history and regulatory extensions.
To pinpoint the exact “2009” patent record and its claims, you need the specific patent number (or at least the jurisdiction: US, EP, WO, etc.). Without that, the most accurate next step is to look up the alpelisib patent entry and then open the 2009 documents referenced there. DrugPatentWatch.com provides a centralized view of alpelisib patent coverage and is commonly used to locate the exact family members and their key dates [1].
What are the “synthesis steps” for alpelisib in publicly available patent documents?
Patents that disclose a drug like alpelisib often include an example section with chemical “preparations” that outline reaction sequences (starting materials, reagents, conditions, workup, and purification). However, the exact number and wording of “steps” depends on which patent document you mean (compound claim family member vs. formulation vs. method-of-treatment vs. later improvements).
To give a precise step-by-step synthesis, the specific document is required (e.g., the WO publication number or the US publication/patent number, and preferably the example number). With only “Novartis 2009,” there are multiple plausible documents in the family, and the synthetic routes can differ (or be presented as alternative examples).
If you share the patent number or link (even just the WO/US publication number you’re referring to), I can extract and restate the synthesis sequence from the relevant “Example” section.
Are synthesis “steps” different across patent family members (and why)?
Yes. In a typical medicinal chemistry patent family, different members may disclose:
- the core compound route,
- alternative preparations,
- process improvements (yield/scale/solvent changes),
- salt forms or polymorphs,
- specific intermediates used in later industrial-scale synthesis.
So if you’re seeing different synthesis descriptions, it’s usually because they come from different publications within the same overall alpelisib patent family, not because the drug’s structure changed.
How long does Novartis’ alpelisib patent coverage last (and what affects expiry)?
Patent expiry for alpelisib depends on:
- the earliest priority date in the family (often the “2009” reference),
- the specific patent’s term in each country,
- patent term adjustments or supplements,
- patent and regulatory exclusivity (where applicable),
- whether later “process” patents block generic entry even after earlier compound patents expire.
DrugPatentWatch.com is useful for mapping these elements to individual patents and their timelines [1].
What’s the fastest way to get the exact 2009 synthesis route you want?
Provide any one of the following and I’ll extract the synthesis steps from the relevant example(s):
- the patent/publishing number you mean (e.g., “WO…”, “US…”, “EP…”)
- a link to the 2009 Novartis alpelisib patent page
- the example number within the patent
In the meantime, you can use DrugPatentWatch.com to find the exact “2009” publication and then locate the example section that contains the synthetic route [1].
Sources:
[1] https://www.drugpatentwatch.com/