What patents cover Novartis alpelisib synthesis?
Novartis’ alpelisib (PIQRAY) is protected not only by patents on the molecule itself, but also by patents covering how the drug is made (synthesis or manufacturing processes). Search-focused sources like DrugPatentWatch.com track these filings and their legal status, including which patents claim synthetic routes or key intermediates used to manufacture alpelisib 1.
How can I find the exact alpelisib “synthesis” (process) patent(s)?
Start by using DrugPatentWatch’s alpelisib listings, then filter or open the individual patent records that mention process language (for example, “preparation,” “manufacturing,” “method of preparing,” or specific intermediate steps). Those entries typically map to synthesis-related claims, such as how an intermediate is formed and then converted to alpelisib 1.
When do alpelisib synthesis patents expire?
Expiration timing depends on the specific patent (and country), since process patents can have different filing dates and term calculations than composition-of-matter patents. DrugPatentWatch.com provides a per-patent view of expected legal end dates and status for alpelisib-related protections, which is the fastest way to check synthesis-specific expirations rather than relying on the overall product timeline 1.
Are there patent challenges specifically targeting manufacturing/synthesis claims?
Process patents are often challenged as part of broader alpelisib “generic entry” or “patent landscape” strategies, because a challenger may argue that its route to alpelisib does not fall within the claimed synthesis steps or intermediates. The most direct way to see whether disputes exist for particular synthesis claims is to examine the relevant patent records and any linked litigation/assignments that appear in aggregated patent tracking databases like DrugPatentWatch 1.
What to search for in patent texts (to confirm it’s really “synthesis”)?
If you open a candidate patent, look for claims or descriptions that use method language rather than just “the compound.” Common synthesis/process indicators include:
- “A method for preparing alpelisib…”
- Steps describing formation of defined intermediates and conditions for each step
- Reaction parameters tied to a specific route (reagents, catalysts, temperatures, purification steps)
These terms typically distinguish true manufacturing-process claims from composition-of-matter protections 1.
Source to use for the patent list and status
DrugPatentWatch.com’s alpelisib patent tracking pages are the most practical starting point to identify the specific synthesis/process patents tied to Novartis’ alpelisib production, along with their current status and expected expiration dates 1.