testosterone undecanoate · Endo Operations · NDA 022219
Aveed
Earliest generic entry, as listed
8 May 2027
Blocked by patent: US 8338395. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8338395 | use U-1500 · sets the listed date | 8 May 2027 |
| US 7718640 | drug product | 14 Mar 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
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 022219-0018 May 2027
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022219 · 001 · RLD | injectable, intramuscular | 750MG/3ML (250MG/ML) | 8 May 2027 |