FDA Orange Book
Generic for Savella
Savella contains milnacipran. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Savella is milnacipran. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Savella products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 12.5MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 25MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 5 | AB |
NDA 022256, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic milnacipran
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BRECKENRIDGE PHARMACEUTICAL INC | 205071 | AB (A-rated, therapeutically equivalent) | January 27, 2016 | 100MG, 12.5MG, 25MG, 50MG |
| AMNEAL PHARMACEUTICALS | 205081 | AB (A-rated, therapeutically equivalent) | April 22, 2016 | 100MG, 12.5MG, 25MG, 50MG |
| HETERO LABS LTD UNIT V | 205147 | AB (A-rated, therapeutically equivalent) | October 3, 2024 | 100MG, 12.5MG, 25MG, 50MG |
| MACLEODS PHARMACEUTICALS LTD | 210944 | AB (A-rated, therapeutically equivalent) | September 15, 2026 | 100MG, 12.5MG, 25MG, 50MG |
| STRIDES PHARMA GLOBAL PTE LTD | 207399 | AB (A-rated, therapeutically equivalent) | September 15, 2026 | 100MG, 12.5MG, 25MG, 50MG |
Savella patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7994220 | September 19, 2029 | Method of use | U-819 | 022256 |
Savella NDC codes
Questions
Is there a generic for Savella?
Yes. The generic name for Savella is milnacipran. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Savella?
The active ingredient in Savella is milnacipran, per the FDA Orange Book.
When does the Savella patent expire?
The last patent listed for Savella in the Orange Book expires September 19, 2029. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.