Drug profile
Lumacaftor
GenericRadar assessment
Patent Radar Assessment
Grade B1
United States · 2030 Radar
Verification
HIGH
Why not A?
Not Grade A: the 2030 DS/DP-listed patent US8507534 is a specific Form-I polymorph/crystal event. Earlier lumacaftor patent families cover the compound/product. Therefore the 2030 event is a solid-form lifecycle event, not the original composition-of-matter cliff.
Core Patent Expiry
2027-05-20
2030 Target Event
US8507534
Polymorph / Form-I Crystal · 2030-09-20
Core API Event?
No
Later Blocking Patents
Yes. Other ORKAMBI product/composition patents also run through late 2030, and combination-product claims must be assessed separately from lumacaftor API.
Generic Entry Assessment
Important API solid-form opportunity. API suppliers must be checked for polymorph/form control and freedom-to-operate, not merely chemical identity.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US8507534 | Polymorph / Form-I Crystal | 2030-09-20 | Protected | Yes | 40 |
API sourcing
Regulatory filing labels distinguish verified/listed records from records that have not yet been verified. “Not verified” does not mean that a filing does not exist.
| API | Manufacturer | Country | US DMF | KDMF | Japan MF | CEP | EU GMP | Status |
|---|---|---|---|---|---|---|---|---|
| Lumacaftor | No supplier linked | — | — | — | — | Not verified | — |