Drug profile
Ledipasvir
GenericRadar assessment
Patent Radar Assessment
Grade A1
United States · 2030 Radar
Verification
HIGH
Why Grade A?
UNITAID/WTO materials identify ledipasvir primary patent expiry in 2030; current U.S. Orange Book-derived data also show multiple 2030 DS/DP patents, including US8822430 expiring 2030-05-12.
Core Patent Expiry
2030-05-12
2030 Target Event
US8822430
Drug Substance / Drug Product · 2030-05-12
Core API Event?
Yes
Later Blocking Patents
Yes. HARVONI has later product/use and DS/DP patents extending beyond 2030, including events in 2032-2034.
Generic Entry Assessment
Core/primary 2030 event is meaningful, but HARVONI is a ledipasvir/sofosbuvir combination and the full combination patent landscape must be reviewed.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US8822430 | Drug Substance / Drug Product | 2030-05-12 | Protected | Yes | 66 |
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 |
|---|---|---|---|---|---|---|---|---|
| Ledipasvir | Fuxin Long Rui Pharmaceutical | China | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |
| Ledipasvir | Lupin Ltd | India | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |
| Ledipasvir | Viatris | United States | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |