Patent Cliff
Upcoming loss-of-exclusivity events from the Orange Book, scored for how contestable the market actually is.
Open Patent Cliff -- in the sidebar under Drug Intelligence.
A patent expiry is only an opportunity if somebody can act on it. Patent Cliff starts from the FDA Orange Book, works out when each brand's protection actually lapses, and then scores what the market looks like on the far side.
Patent mode and exclusivity mode
A toggle at the top switches the whole page between two clocks:
- Patent -- when the listed patents expire.
- Exclusivity -- when the FDA-granted exclusivity gates expire.
They are different dates and often years apart. A drug can be patent-free but still blocked by exclusivity, and vice versa. The market open date is the latest of all gates, and that is the date a generic can actually launch.
Contestability tiers
Every row carries one of four chips, based on how many generic makers are actively marketing the ingredient (not merely holding an approval):
| Tier | Meaning |
|---|---|
| Greenfield | No generic actively marketed. First-mover opening. |
| Open | Only a few generics actively marketed. Room to enter. |
| Crowded | Several generics actively competing. |
| Eroded | Heavily genericized. Margins likely already compressed. |
Hover the chip for the full breakdown: makers actively marketing, makers whose every listing is discontinued (counted separately, not counted as competition), live ANDA listings, whether a Reference Listed Drug is on file, and whether any generic carries an AB therapeutic-equivalence rating. That last one matters: without an AB rating a pharmacist cannot substitute automatically, so brand share erodes far more slowly than the generic count implies.
Other row badges
- Staged -- tentatively approved generic applications. FDA-cleared, blocked only by patent or exclusivity, positioned to launch the day protection lapses.
- Discontinued -- every Orange Book listing for this brand is marked DISCN across all years. The protection date still lapses, but it opens an empty market.
- Brand opens / Blocked to -- this listing's protection lapses on the date shown, but another listing for the same brand runs later. Generic entry stays blocked until that later date.
- No AB substitute -- generics exist but none are automatically substitutable.
Tabs
Cliff wave
The default view. Loss-of-exclusivity events grouped by year, with per-row contestability, staged-generic counts and Medicare exposure where it can be measured. This is the screening list.