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Last Updated: September 29, 2020

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Asenapine - Generic Drug Details

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

Asenapine is the generic ingredient in two branded drugs marketed by Hisamitsu and Allergan, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Asenapine has thirty-eight patent family members in nine countries.

There are twelve drug master file entries for asenapine. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for asenapine
International Patents:38
US Patents:6
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 12
Suppliers / Packagers: 1
Bulk Api Vendors: 59
Clinical Trials: 54
Patent Applications: 1,965
DailyMed Link:asenapine at DailyMed
Recent Clinical Trials for asenapine

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

SponsorPhase
Lindner Center of HOPEPhase 2
Noven Pharmaceuticals, Inc.Phase 3
Centre for Addiction and Mental HealthPhase 4

See all asenapine clinical trials

Generic filers with tentative approvals for ASENAPINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET;SUBLINGUAL
  Start Trial  Start Trial5MGTABLET;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

US Patents and Regulatory Information for asenapine

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   Start Trial
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-003 Oct 11, 2019 RX Yes Yes   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
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-002 Oct 11, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-003 Oct 11, 2019 RX Yes Yes   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 Y   Start Trial
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 RX Yes No   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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 C300461 Netherlands   Start Trial PRODUCT NAME: ASENAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MALEAAT; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
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
0746317 10C0056 France   Start Trial PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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