Drug profile
Cedazuridine
GenericRadar assessment
Patent Radar Assessment
Grade A2
United States · 2030 Radar
Verification
MEDIUM
Why Grade A?
Current Orange Book-derived INQOVI record lists US8268800 as a Drug Substance patent expiring 2030-08-22.
Core Patent Expiry
2030-08-22
2030 Target Event
US8268800
Drug Substance · 2030-08-22
Core API Event?
Yes
Later Blocking Patents
Yes. INQOVI has later Drug Product/method patents extending into 2040-2041.
Generic Entry Assessment
Strong DS event for cedazuridine, but INQOVI is a combination product and later product/use patents must be separated from API sourcing opportunity.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US8268800 | Drug Substance | 2030-08-22 | Protected | Yes | 48 |
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 |
|---|---|---|---|---|---|---|---|---|
| Cedazuridine | ScinoPharm Taiwan Ltd | Taiwan | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US submission / US DMF |