Drug profile
Ombitasvir
GenericRadar assessment
Patent Radar Assessment
Grade C1
United States · 2030 Radar
Verification
HIGH
Why not A?
In the U.S. 2026 Orange Book, the 2030 VIEKIRA/TECHNIVIE patent event US9006387 is a method-of-use patent (U-1687), not a Drug Substance patent. U.S. DS/DP patents for the regimen occur in 2028-2029 and 2031-2032.
Core Patent Expiry
Not established
2030 Target Event
US9006387
Method of Use · 2030-06-10
Core API Event?
No
Later Blocking Patents
Yes. U.S. Drug Substance/Drug Product protection includes later events after 2030.
Generic Entry Assessment
Do not treat the U.S. 2030 event as an API patent cliff. Ombitasvir may have 2030 primary/SPC events in other jurisdictions, which should be stored as separate country assessments.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US9006387 | Method of Use | 2030-06-10 | Protected | Yes | 42 |
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 |
|---|---|---|---|---|---|---|---|---|
| Ombitasvir | No supplier linked | — | — | — | — | Not verified | — |