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Last Updated: January 28, 2022

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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 three branded drugs marketed by Hisamitsu, Alembic Pharms Ltd, Breckenridge, Sigmapharm Labs Llc, and Allergan, and is included in five NDAs. There are seven 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.

Summary for asenapine
International Patents:38
US Patents:7
Tradenames:3
Applicants:5
NDAs:5
Drug Master File Entries: 12
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 71
Clinical Trials: 55
Patent Applications: 4,662
Drug Prices: Drug price trends for asenapine
What excipients (inactive ingredients) are in asenapine?asenapine excipients list
DailyMed Link:asenapine at DailyMed
Drug Prices for asenapine

See drug prices for asenapine

Recent Clinical Trials for asenapine

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

SponsorPhase
Lindner Center of HOPEPhase 2
National Alliance on Mental Illness Montana
CGStat LLC

See all asenapine clinical trials

Pharmacology for asenapine
Anatomical Therapeutic Chemical (ATC) Classes 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
Alembic Pharms Ltd ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-003 Jul 19, 2021 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-003 Oct 11, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for asenapine

Country Patent Number Estimated Expiration
Japan 2016199603 ⤷  Sign up for a Free Trial
China 104507472 ⤷  Sign up for a Free Trial
South Korea 102013476 ⤷  Sign up for a Free Trial
South Korea 20150036479 ⤷  Sign up for a Free Trial
Taiwan I603748 ⤷  Sign up for a Free Trial
Poland 2878299 ⤷  Sign up for a Free Trial
Taiwan 201410270 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for asenapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 SPC/GB10/046 United Kingdom ⤷  Sign up for a Free 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 ⤷  Sign up for a Free Trial PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317 C300461 Netherlands ⤷  Sign up for a Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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