milnacipran hydrochloride · Abbvie · NDA 022256
Savella
Earliest generic entry, as listed · earliest of 4 marketed strengths
19 Sep 2029
Blocked by patent: US 7994220. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7994220 | use U-819 | 19 Sep 2029 |
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
- 25 Oct 2026Generic approved · 022256-00115 Sep 2026
- 25 Oct 2026Generic approved · 022256-00115 Sep 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022256 · 001 · RLD | tablet, oral | 12.5MG | 19 Sep 2029 |
| 022256 · 002 · RLD | tablet, oral | 25MG | 19 Sep 2029 |
| 022256 · 003 · RLD | tablet, oral | 50MG | 19 Sep 2029 |
| 022256 · 004 · RLD | tablet, oral | 100MG | 19 Sep 2029 |