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FDA Orange Book · active-ingredient family

Asenapine maleate

Asenapine maleate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SAPHRIS · NDA 022117

1

Brand (NDA)

3

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
SAPHRISRLD×3ABBVIENDA 022117ABMar 12, 2015

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
ASENAPINE MALEATE×3ALEMBICANDA 206098ABJul 19, 2021
ASENAPINE MALEATE×3BRECKENRIDGEANDA 205960ABDec 10, 2020
ASENAPINE MALEATE×2SIGMAPHARM LABS LLCANDA 206107ABDec 10, 2020

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7741358Apr 06, 20262 mo ago
SubstanceProductU-1966
8022228Apr 06, 20262 mo ago
SubstanceProduct
7741358*PEDOct 06, 2026in 4 mo
8022228*PEDOct 06, 2026in 4 mo

Asenapine maleate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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