Drug profile
Ceritinib
GenericRadar assessment
Patent Radar Assessment
Grade A2
United States · 2030 Radar
Verification
MEDIUM
Why Grade A?
US8039479 is currently listed for ZYKADIA as Drug Substance/Drug Product with a 2030-06-29 expiration.
Core Patent Expiry
2030-06-29
2030 Target Event
US8039479
Drug Substance / Drug Product · 2030-06-29
Core API Event?
Yes
Later Blocking Patents
Yes. Additional ZYKADIA Drug Substance/Drug Product patents extend into 2032 and method-of-use protection extends later.
Generic Entry Assessment
Meaningful 2030 DS event, but not the final U.S. protection horizon.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US8039479 | Drug Substance / Drug Product | 2030-06-29 | Protected | Yes | 49 |
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 |
|---|---|---|---|---|---|---|---|---|
| Ceritinib | MSN Laboratories | India | ✓ Active · 32553 | Not verified | Not verified | Not verified | Not verified | Active US DMF |