testosterone undecanoate · Tolmar · NDA 206089
Jatenzo
Earliest generic entry, as listed · earliest of 3 marketed strengths
12 Apr 2039
Blocked by patent: US 11564933, US 12605391. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11564933 | use U-1103 | 12 Apr 2039 |
| US 12605391 | use U-1103 | 12 Apr 2039 |
| US 8492369 | product, use U-2506 | 20 Dec 2030 |
| US 10543219 | use U-2506 | 12 Apr 2030 |
| US 10617696 | substance, product | 12 Apr 2030 |
| US 11179403 | use U-2506 | 12 Apr 2030 |
| US 11426416 | use U-3420 | 12 Apr 2030 |
| US 8778916 | product | 12 Apr 2030 |
| US 8241664 | product, use U-2506 | 29 Mar 2029 |
| US 11331325 | use U-2506 | 6 Jan 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206089 · 001 · RLD | capsule, oral | 158MG | 12 Apr 2039 |
| 206089 · 002 · RLD | capsule, oral | 198MG | 12 Apr 2039 |
| 206089 · 003 · RLD | capsule, oral | 237MG | 12 Apr 2039 |
Expired or delisted (1)
- US 11179402 · substance, product · 14 Apr 2026