Drug profile
Dapagliflozin
GenericRadar assessment
Patent Radar Assessment
Grade B1
United States · 2030 Radar
Verification
HIGH
Why not A?
Not Grade A: the original U.S. compound patent US6515117 expired earlier. The selected 2030 event is the pediatric-extension expiry of US7919598, a polymorph/crystal-form patent, not the original composition-of-matter cliff.
Core Patent Expiry
2026-04-04
2030 Target Event
US7919598
Polymorph / Crystal Form (PED) · 2030-06-16
Core API Event?
No
Later Blocking Patents
Yes. Additional product and method-of-use patent events also occur in 2030-2031.
Generic Entry Assessment
2030 remains commercially relevant because crystal-form and use/product patents may affect formulation and launch strategy, but it is not a core API-patent cliff.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US7919598 | Polymorph / Crystal Form (PED) | 2030-06-16 | 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 |
|---|---|---|---|---|---|---|---|---|
| Dapagliflozin propanediol monohydrate | No supplier linked | — | — | — | — | Not verified | — |