➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Moodys
Medtronic
McKinsey
Baxter

Last Updated: August 10, 2020

DrugPatentWatch Database Preview

Asenapine maleate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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 one branded drug marketed by Allergan and is included in one NDA. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Asenapine maleate has thirty-five patent family members in twenty-one countries.

There are twelve drug master file entries for asenapine maleate. Two suppliers are listed for this compound. There is one tentative approval 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

Generic filers with tentative approvals for ASENAPINE MALEATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 5MG BASETABLET;SUBLINGUAL
  Start Trial  Start TrialEQ 10MG BASETABLET;SUBLINGUAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology 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 022117-002 Aug 13, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for asenapine maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 122010000050 Germany   Start Trial PRODUCT NAME: ASENAPINHALTIGES ARZNEIMITTEL; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
0746317 10C0056 France   Start Trial PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317 C00746317/01 Switzerland   Start Trial PRODUCT NAME: ASENAPINUM; REGISTRATION NO/DATE: SWISSMEDIC 62073 20.07.2012
0746317 91751 Luxembourg   Start Trial 91751, EXPIRES: 20200301
0746317 SPC032/2010 Ireland   Start Trial SPC032/2010: 20101210, EXPIRES: 20200228
0746317 SPC/GB10/046 United Kingdom   Start Trial PRODUCT NAME: ASENAPINE; REGISTERED: UK EU/1/10/640/001 20100901; UK EU/1/10/640/002 20100901; UK EU/1/10/640/003 20100901; UK EU/1/10/640/004 20100901; UK EU/1/10/640/005 20100901; UK EU/1/10/640/006 20100901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Moodys
Boehringer Ingelheim
Medtronic
McKesson
Express Scripts

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.