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Last Updated: December 4, 2021

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Asenapine maleate - Generic Drug Details

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What are the generic drug 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 Pharms Ltd, 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. Eight suppliers are listed for this compound.

Recent Clinical Trials for asenapine maleate

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

SponsorPhase
Accutest Research Laboratories (I) Pvt. Ltd.Phase 2/Phase 3
Amneal Pharmaceuticals, LLCPhase 2/Phase 3
bioRASI, LLCPhase 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 NDA Submissiondate
SAPHRIS TABLET;SUBLINGUAL asenapine maleate 022117 2017-07-27
SAPHRIS TABLET;SUBLINGUAL asenapine maleate 022117 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 022117-001 Aug 13, 2009 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Sigmapharm Labs Llc ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206107-002 Dec 10, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Breckenridge ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 205960-002 Dec 10, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alembic Pharms Ltd ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-001 Dec 10, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alembic Pharms Ltd ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-002 Dec 10, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sigmapharm Labs Llc ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206107-001 Dec 10, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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