FDA Orange Book · active-ingredient family
Asenapine maleate
Asenapine maleate: 1 brand, 3 generics; first approved Aug 13, 2009; generic available.
Generic available
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
4
Next patent expiry
Apr 06, 2026
5 mo ago
Brand (NDA) products
Originator applications
- SAPHRISRLDABBVIENDA 02211720153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET SUBLINGUAL Rx AB EQ 10MG BASE TABLET SUBLINGUAL Rx AB EQ 2.5MG BASE TABLET SUBLINGUAL Rx AB
Generic (ANDA) products (3)
Abbreviated applications
- ASENAPINE MALEATEALEMBICANDA 20609820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET SUBLINGUAL Rx AB EQ 10MG BASE TABLET SUBLINGUAL Rx AB EQ 2.5MG BASE TABLET SUBLINGUAL Rx AB - ASENAPINE MALEATEBRECKENRIDGEANDA 20596020203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE TABLET SUBLINGUAL Rx AB EQ 10MG BASE TABLET SUBLINGUAL Rx AB EQ 5MG BASE TABLET SUBLINGUAL Rx AB - ASENAPINE MALEATESIGMAPHARM LABS LLCANDA 20610720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET SUBLINGUAL Rx AB EQ 10MG BASE TABLET SUBLINGUAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7741358 | 5 mo ago | SubstanceProductU-1966 | |
| 8022228 | 5 mo ago | SubstanceProduct | |
| 7741358*PED | in 1 mo | ||
| 8022228*PED | in 1 mo |
Approval history
FDA approval span
First approval
17 yr 3 mo ago
Most recent approval
5 yr 2 mo ago
Approvals span 2009–2021 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Asenapine maleate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
