FDA Orange Book
Generic for Saphris
Saphris contains asenapine. 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 Saphris is asenapine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Saphris products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, sublingual | EQ 10MG BASE | Marketed (Rx) | AB | 3 | AB |
| tablet, sublingual | EQ 2.5MG BASE | Marketed (Rx) | AB | 2 | AB |
| tablet, sublingual | EQ 5MG BASE | Marketed (Rx) | AB | 3 | AB |
NDA 022117, 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 asenapine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 206098 | AB (A-rated, therapeutically equivalent) | December 10, 2020 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| BRECKENRIDGE PHARMACEUTICAL INC | 205960 | AB (A-rated, therapeutically equivalent) | December 10, 2020 | EQ 10MG BASE, EQ 2.5MG BASE, EQ 5MG BASE |
| SIGMAPHARM LABORATORIES LLC | 206107 | AB (A-rated, therapeutically equivalent) | December 10, 2020 | EQ 10MG BASE, EQ 5MG BASE |
Saphris patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7741358 | April 6, 2026 | Drug substance, Drug product | U-1966 | 022117 |
| 7741358 | April 6, 2026 | Drug substance, Drug product | U-1893 | 022117 |
| 8022228 | April 6, 2026 | Drug substance, Drug product | None | 022117 |
| 7741358 | April 6, 2026 | Drug substance, Drug product | U-1960 | 022117 |
| 7741358 | April 6, 2026 | Drug substance, Drug product | U-1064 | 022117 |
| 7741358 | April 6, 2026 | Drug substance, Drug product | U-1961 | 022117 |
| 7741358 | April 6, 2026 | Drug substance, Drug product | U-1962 | 022117 |
| 7741358 | April 6, 2026 | Drug substance, Drug product | U-1963 | 022117 |
| 7741358*PED | October 6, 2026 | Method of use | None | 022117 |
| 8022228*PED | October 6, 2026 | Method of use | None | 022117 |
Saphris NDC codes
Questions
Is there a generic for Saphris?
Yes. The generic name for Saphris is asenapine. 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 Saphris?
The active ingredient in Saphris is asenapine, per the FDA Orange Book.
When does the Saphris patent expire?
The last patent listed for Saphris in the Orange Book expires October 6, 2026. 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.