You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Asenapine maleate - Generic Drug Details


✉ Email this page to a colleague

« 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 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
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sigmapharm Labs Llc ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206107-002 Dec 10, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

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.