Alpelisib

Sold as PIQRAY, VIJOICE · given by oral

Ten years or more until it comes off patent
10.5 yr
Until anyone may copy it
Protection runs to 2037-02-17
19
Trials running now
128 registered in total
Phase 3
Furthest stage reached
large trials measuring benefit
3
Organisations running trials
lead sponsors on record
01

Who owns it, and until when

Novartis Pharmaceuticals Corp
Approval holder
the only company permitted to sell it today
2037-02
Last patent expires
latest patent filed against this product
2029-04
FDA exclusivity ends
a separate protection granted at approval

Whichever date falls later is when other manufacturers may apply to sell copies. Price typically falls steeply within a year of that point, and with it any company's ability to recover the cost of new research on the molecule. That is when it becomes a candidate for the ledger on the first tab.

02

What it is being tested for

Breast CancerMetastatic Breast CancerHER2-negative Breast Cancer
03

Who is paying for the research

Novartis Pharmaceuticals
Company
22
Pamela Munster
University or hospital
2
Peter MacCallum Cancer Centre, Aus
University or hospital
2

Who funds the trials matters after protection lapses. Company-funded work usually stops once exclusivity ends; university, hospital and government-funded work does not, and is the research most likely to continue on this molecule afterwards.

04

The trials themselves

NCT07679269Phase 22027 · 51 people · not yet recruiting
Roll-Over Study of Alpelisib (BYL719) for Co

Expiry dates are what the patent holder has filed; litigation, paediatric extensions and settlements routinely move them, so read these as the earliest plausible date rather than a schedule. Not medical advice.

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