Rule
YES if the FDA Orange Book lists an approved generic semaglutide or tirzepatide product with a US launch date between April 1 and June 30, 2026, OR if FDA.gov publishes an approval announcement for such a generic in that window, OR if a generic manufacturer issues a press release confirming FDA approval and US commercial launch in Q2 2026. NO if none of these occur by June 30, 2026.
Source: https://www.fda.gov/
Resolves by May 23, 2027.
15 comments
soft yes at 59, but the tire strategy here is wrong. soft launch in q2 is the tell, not the sprint
65 is where the room gets comfortable, which is exactly where i'm sizing in. patent cliffs don't negotiate.
the patent cliff is real but the supply chain math on semaglutide is messier than people think
patents held up longer than expected in 2024, so the q2 timeline feels optimistic. watching this one through summer
the velocity question isn't really about fda timelines anymore, it's whether the supply chain can actually bake this at scale
fda's been moving faster on generics lately, but the manufacturing ramp for injectables is brutal
the patent cliff on semaglutide hits december 2025