Drug profile
Empagliflozin
GenericRadar assessment
Patent Radar Assessment
Grade C1
United States · 2030 Radar
Verification
HIGH
Why not A?
Not Grade A: FDA lists US12115179 as a use-code patent (U-4023), not as Drug Substance. The JARDIANCE Drug Substance patents US7713938 and US7579449 expire earlier, with the latter pediatric extension ending in 2029.
Core Patent Expiry
2029-02-01
2030 Target Event
US12115179
Method of Use / Use Code U-4023 · 2030-02-11
Core API Event?
No
Later Blocking Patents
Yes. JARDIANCE has numerous later method-of-use patents extending into 2033-2034.
Generic Entry Assessment
The 2030 event is indication/use protection and may permit different generic strategies depending on label carve-outs; it is not an API composition cliff.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US12115179 | Method of Use / Use Code U-4023 | 2030-02-11 | Protected | Yes | 45 |
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 |
|---|---|---|---|---|---|---|---|---|
| Empagliflozin | No supplier linked | — | — | — | — | Not verified | — |