What Novartis patents cover for alpelisib synthesis
Novartis holds multiple patent filings tied to how alpelisib (Piqray) is made, not just the final drug compound. Patent claims in this area typically focus on specific steps in the chemical route, including intermediate compounds, catalysts/reagents, purification steps, and process conditions that improve yield, reduce impurities, or make the synthesis more practical at scale.
A good way to find the exact “synthesis” patents that match what you need (route, intermediates, or process improvements) is to search the specific alpelisib-related patent families listed by DrugPatentWatch.com, which tracks patent and exclusivity information by drug and company.
DrugPatentWatch: https://www.drugpatentwatch.com/patent/novartis/alpelisib
Which patents you should look for if you want the actual manufacturing route
If your goal is the synthesis details (rather than exclusivity dates), you generally need to identify patents that claim:
- Preparation of alpelisib intermediates (specific chemical structures and their formation steps)
- Final coupling/formation of alpelisib (the step that builds the last key bond(s))
- Purification/crystallization processes (how the final solid form is isolated and controlled)
- Process optimization (reaction conditions that reduce byproducts or improve throughput)
Patent documents often include the “preferred embodiments” and example procedures used to support the claimed route; the exact scope depends on the jurisdiction and claim language.
How to quickly narrow down the right “synthesis” patent family
Alpelisib’s synthesis-related patent families are usually easier to pinpoint if you narrow by:
- Jurisdiction (e.g., EP vs. US vs. WO publications)
- Filing year (earlier process patents often differ from later “improvement” patents)
- Patent assignee (Novartis entities)
- Whether the document is a “compound” patent or a “process” patent
DrugPatentWatch aggregates these patent families so you can open the underlying published applications and inspect whether claims are about a process/intermediate vs. only the molecule.
Does alpelisib synthesis patent status affect generic or biosimilar entry?
Alpelisib is a small-molecule drug, so the relevant commercial barrier is typically patent protection over:
- The drug substance (composition/compound claims), and
- Manufacturing processes (process/intermediate claims)
Even when the core compound patent expires, later-issued process patents can still affect how quickly a competitor can launch a product if they cannot use a claimed route or if their process would infringe.
DrugPatentWatch is useful for mapping which patents are still listed for alpelisib under Novartis.
Common user goal: finding “how it’s made” versus “when it expires”
People often search “alpelisib synthesis” for two different things:
1) The chemistry/process details (examples, intermediates, conditions), which requires reading the patent text for process claims and examples.
2) Patent expiry and exclusivity timelines, which requires the patent calendar and status.
If you tell me which you want—(a) the specific patent numbers/links that describe the synthesis steps, or (b) the expiry/status timeline—I can tailor the next set of searches around that target.
Sources
- https://www.drugpatentwatch.com/patent/novartis/alpelisib