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Ledipasvir; Sofosbuvir

Sold as HARVONI · given by oral

Five to ten years until it comes off patent
7.9 yr
Until anyone may copy it
Protection runs to 2034-07-30
0
Trials running now
138 registered in total
In routine use
Furthest stage reached
already in routine clinical use
3
Organisations running trials
lead sponsors on record
01

Who owns it, and until when

Gilead Sciences Inc
Approval holder
the only company permitted to sell it today
2034-07
Last patent expires
latest patent filed against this product
2026-08
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

Hepatitis CHepatitis C, ChronicChronic Hepatitis C
03

Who is paying for the research

Gilead Sciences
Company
23
Ain Shams University
University or hospital
3
University of Maryland, Baltimore
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

NCT04530422Phase 32020 · 250 people · completed
Efficacy of Sofosbuvir Plus Ledipasvir in Eg

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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