testosterone · Eli Lilly And Co · NDA 022504
Axiron
Earliest generic entry, as listed
27 Sep 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8435944. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8435944 | use U-1390 · sets the listed date | 27 Sep 2027 |
| US 8419307 | use U-1386 | 26 Feb 2027 |
| US 8807861 | drug product, use U-1563 | 26 Feb 2027 |
| US 9289586 | use U-1390 | 26 Feb 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
- Enters 12-month window basis: patent, carve-out possible · 022504-001Listed date 27 Sep 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022504 · 001 · RLD · discontinued | solution, metered, transdermal | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Sep 2027 |
Expired or delisted (2)
- US 8993520 · use U-1390 · 2 Jun 2026
- US 9180194 · use U-1390 · 2 Jun 2026