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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Johnson and Johnson
Baxter
Colorcon
Boehringer Ingelheim

Last Updated: December 7, 2021

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ASENAPINE MALEATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Asenapine Maleate

A generic version of ASENAPINE MALEATE was approved as asenapine maleate by ALEMBIC PHARMS LTD on December 10th, 2020.

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Drug patent expirations by year for ASENAPINE MALEATE
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
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 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
Alembic Pharms Ltd ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-003 Jul 19, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sigmapharm Labs Llc ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206107-001 Dec 10, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Breckenridge ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 205960-001 Dec 10, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sigmapharm Labs Llc ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206107-002 Dec 10, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alembic Pharms Ltd ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-001 Dec 10, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alembic Pharms Ltd ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-002 Dec 10, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Breckenridge ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 205960-002 Dec 10, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Colorcon
AstraZeneca
Express Scripts
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.