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Last Updated: November 21, 2024

ASENAPINE MALEATE - Generic Drug Details


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What are the generic sources for asenapine maleate and what is the scope of freedom to operate?

Asenapine maleate is the generic ingredient in two branded drugs marketed by Alembic, Breckenridge, Sigmapharm Labs Llc, and Allergan, and is included in four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for asenapine maleate. Seven suppliers are listed for this compound.

Recent Clinical Trials for ASENAPINE MALEATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Amneal Pharmaceuticals, LLCPhase 2/Phase 3
Accutest Research Laboratories (I) Pvt. Ltd.Phase 2/Phase 3
Sun Pharmaceutical Industries LimitedPhase 1

See all ASENAPINE MALEATE clinical trials

Pharmacology for ASENAPINE MALEATE
Anatomical Therapeutic Chemical (ATC) Classes for ASENAPINE MALEATE
Paragraph IV (Patent) Challenges for ASENAPINE MALEATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SAPHRIS Sublingual Tablets asenapine maleate 2.5 mg 022117 1 2017-07-27
SAPHRIS Sublingual Tablets asenapine maleate 5 mg and 10 mg 022117 4 2013-08-13

US Patents and Regulatory Information for ASENAPINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Breckenridge ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 205960-002 Dec 10, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sigmapharm Labs Llc ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206107-002 Dec 10, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-001 Dec 10, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ASENAPINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 ⤷  Sign Up ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 ⤷  Sign Up ⤷  Sign Up
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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