Drug
Who makes asenapine maleate?
3 companies list asenapine maleate as a human prescription drug, including under the names SAPHRIS. Forms: tablet. Routes: sublingual.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing asenapine maleate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| MSN Laboratories Private Limited,India | tablet | ANDAANDA205960 | 5 | 8 |
| Breckenridge Pharmaceutical, Inc. | tablet | ANDAANDA205960 | 5 | 0 |
| Allergan, Inc.United States | tablet | NDANDA022117 | 3 | 7 |
Bulk ingredient listings
- MSN Organics Private LimitedIndia · 2 NDC
- Aspen Oss B.V.Netherlands · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Medichem SASpain · 1 NDC
- Olon USA LLCItaly · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Orange Book patents
2 unexpired patents list asenapine maleate as the active ingredient, expiring between Oct 2026 and Oct 2026. Application holder: ABBVIE INC.
Enquiry
Common questions
- Who makes asenapine maleate?
- 3 companies list asenapine maleate as a human prescription drug in the openFDA NDC Directory, led by MSN Laboratories Private Limited,, Breckenridge Pharmaceutical, Inc., Allergan, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic SAPHRIS?
- 2 companies list asenapine maleate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies asenapine maleate active ingredient?
- 6 companies list asenapine maleate as a bulk ingredient, including MSN Organics Private Limited, Aspen Oss B.V., Dr. Reddy's Laboratories Limited, Medichem SA.