FDA Orange Book
Generic for Xadago
Xadago contains safinamide. 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 Xadago is safinamide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Xadago products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | AB | 3 | AB |
NDA 207145, held by MDD US OPERATIONS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic safinamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PRINSTON PHARMACEUTICAL INC | 215739 | AB (A-rated, therapeutically equivalent) | April 25, 2024 | EQ 100MG BASE, EQ 50MG BASE |
| MSN LABORATORIES PRIVATE LTD | 215978 | AB (A-rated, therapeutically equivalent) | December 31, 2024 | EQ 100MG BASE, EQ 50MG BASE |
| PHARMAZONE | 215913 | AB (A-rated, therapeutically equivalent) | June 13, 2025 | EQ 100MG BASE, EQ 50MG BASE |
Xadago patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8278485 | June 8, 2027 | Drug substance | U-1993 | 207145 |
| 8076515 | December 10, 2028 | Drug substance, Drug product | U-1993 | 207145 |
| 8283380 | March 21, 2031 | Method of use | U-1993 | 207145 |
Xadago NDC codes
Questions
Is there a generic for Xadago?
Yes. The generic name for Xadago is safinamide. 3 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 Xadago?
The active ingredient in Xadago is safinamide, per the FDA Orange Book.
When does the Xadago patent expire?
The last patent listed for Xadago in the Orange Book expires March 21, 2031. 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.