# SAPHRIS — FDA application NDA022117

Informational only - not investment advice.

Application NDA022117 · type NDA · FDA status: approved · original approval 2009-08-13

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | SAPHRIS | ASENAPINE MALEATE | TABLET | SUBLINGUAL | EQ 5MG BASE | Prescription | AB | Yes |
| 002 | SAPHRIS | ASENAPINE MALEATE | TABLET | SUBLINGUAL | EQ 10MG BASE | Prescription | AB | Yes |
| 003 | SAPHRIS | ASENAPINE MALEATE | TABLET | SUBLINGUAL | EQ 2.5MG BASE | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent 7741358, product 001; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 001; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 001; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 001; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 001; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 002; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 002; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 002; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 002; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 002; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 003; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 003; listed patent expiry date: 2026-04-06.
- Patent 8022228, product 001; listed patent expiry date: 2026-04-06.
- Patent 8022228, product 002; listed patent expiry date: 2026-04-06.
- Patent 8022228, product 003; listed patent expiry date: 2026-04-06.
- Patent 7741358, product 001; listed patent expiry date: 2026-10-06.
- Patent 7741358, product 002; listed patent expiry date: 2026-10-06.
- Patent 7741358, product 003; listed patent expiry date: 2026-10-06.
- Patent 8022228, product 001; listed patent expiry date: 2026-10-06.
- Patent 8022228, product 002; listed patent expiry date: 2026-10-06.
- Patent 8022228, product 003; listed patent expiry date: 2026-10-06.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- ASENAPINE MALEATE · UNII CU9463U2E2 · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA022117. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.