FDA Orange Book
Is there a generic for Barhemsys?
Barhemsys contains amisulpride. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Barhemsys (amisulpride). The Orange Book shows its last listed patent expires February 9, 2038.
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Barhemsys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 10MG/4ML (2.5MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 5MG/2ML (2.5MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 209510, held by LXO IRELAND DESIGNATED ACTIVITY CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Barhemsys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9545426 | March 10, 2031 | Method of use | U-1744 | 209510 |
| 9545426 | March 10, 2031 | Method of use | U-2754 | 209510 |
| 9889118 | March 10, 2031 | Method of use | U-2754 | 209510 |
| 9889118 | March 10, 2031 | Method of use | U-1744 | 209510 |
| 12194022 | March 10, 2031 | Method of use | U-1744 | 209510 |
| 12194022 | March 10, 2031 | Method of use | U-3467 | 209510 |
| 10525033 | March 10, 2031 | Drug product | None | 209510 |
| 9084765 | February 26, 2034 | Method of use | U-1744 | 209510 |
| 9084765 | February 26, 2034 | Method of use | U-2754 | 209510 |
| 9084765 | February 26, 2034 | Method of use | U-3467 | 209510 |
| 12005042 | February 9, 2038 | Method of use | U-1744 | 209510 |
| 12005042 | February 9, 2038 | Method of use | U-3467 | 209510 |
| 12005042 | February 9, 2038 | Method of use | U-2754 | 209510 |
| 11357753 | February 9, 2038 | Method of use | U-2754 | 209510 |
| 12329740 | February 9, 2038 | Method of use | U-2754 | 209510 |
| 12329740 | February 9, 2038 | Method of use | U-3467 | 209510 |
Barhemsys NDC codes
Questions
Is there a generic for Barhemsys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Barhemsys (amisulpride). The Orange Book shows its last listed patent expires February 9, 2038.
What is the generic name for Barhemsys?
The active ingredient in Barhemsys is amisulpride, per the FDA Orange Book.
When does the Barhemsys patent expire?
The last patent listed for Barhemsys in the Orange Book expires February 9, 2038. 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.