FDA Orange Book · active-ingredient family
Milnacipran hydrochloride
Milnacipran hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SAVELLA · NDA 022256
1
Brand (NDA)
3
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SAVELLARLD×4 | ABBVIE | NDA 022256 | AB | Jan 14, 2009 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MILNACIPRAN HYDROCHLORIDE×4 | HETERO LABS LTD V | ANDA 205147 | AB | Oct 03, 2024 | |
| MILNACIPRAN HYDROCHLORIDE×4 | AMNEAL PHARMS | ANDA 205081 | AB | Apr 22, 2016 | |
| MILNACIPRAN HYDROCHLORIDE×4 | BRECKENRIDGE | ANDA 205071 | AB | Jan 27, 2016 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7994220 | Sep 19, 2029 | in 3 yr 4 mo | U-819 |
Milnacipran hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
