Drug profile
Testosterone undecanoate
GenericRadar assessment
Patent Radar Assessment
Grade A2
United States · 2030 Radar
Verification
HIGH
Why Grade A?
FDA Orange Book data lists US10617696 as a Drug Substance/Drug Product patent for JATENZO expiring 2030-04-12.
Core Patent Expiry
2030-04-12
2030 Target Event
US10617696
Drug Substance / Drug Product · 2030-04-12
Core API Event?
Yes
Later Blocking Patents
Yes. JATENZO has use patents extending to 2039; other 2030 product/use patents also exist.
Generic Entry Assessment
2030 DS milestone is real, but testosterone undecanoate itself is an older active ingredient and this assessment is product-specific to JATENZO patent coverage.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US10617696 | Drug Substance / Drug Product | 2030-04-12 | Protected | Yes | 68 |
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 |
|---|---|---|---|---|---|---|---|---|
| Testosterone undecanoate | Aspen API | Netherlands | ✓ Listed | Not verified | Not verified | Not verified | Not verified | Active US DMF |
| Testosterone undecanoate | Bayer AG | Germany | ✓ Active · 16795 | Not verified | Not verified | Not verified | Not verified | Active US DMF |
| Testosterone undecanoate | Hubei Zhuxi Humanwell Pharmaceutical | China | ✓ Active · 40120 | Not verified | Not verified | Not verified | Not verified | Active US DMF |
| Testosterone undecanoate | Pfizer CentreOne | United States | ✓ Active · 24500 | Not verified | Not verified | Not verified | Not verified | Active US DMF |
| Testosterone undecanoate | Symbiotec Pharmalab | India | ✓ Listed | Not verified | Not verified | Not verified | Not verified | Active US DMF |
| Testosterone undecanoate | Zhejiang Xianju Pharmaceutical Co. Ltd | China | ✓ Active · 23934 | Not verified | Not verified | Not verified | Not verified | Active US DMF |