Drug
Who makes asenapine?
3 companies list asenapine as a human prescription drug, including under the names SECUADO. Forms: film, extended release; tablet. Routes: sublingual, transdermal.
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
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | tablet | ANDAANDA206098 | 6 | 7 |
| Noven Pharmaceuticals, Inc.United States | film, extended release | NDANDA212268 | 3 | 1 |
| Sigmapharm Laboratories, LLCUnited States | tablet | ANDAANDA206107 | 2 | 1 |
Orange Book patents
6 unexpired patents list asenapine as the active ingredient, expiring between Jul 2033 and Sept 2033. Application holder: HISAMITSU PHARMACEUTICAL CO INC.
Enquiry
Common questions
- Who makes asenapine?
- 3 companies list asenapine as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Noven Pharmaceuticals, Inc., Sigmapharm Laboratories, LLC. 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 SECUADO?
- 2 companies list asenapine 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.