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Last Updated: September 23, 2020

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SECUADO Drug Profile

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Which patents cover Secuado, and what generic alternatives are available?

Secuado is a drug marketed by Hisamitsu and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-eight patent family members in nine countries.

The generic ingredient in SECUADO is asenapine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the asenapine profile page.

US ANDA Litigation and Generic Entry Outlook for Secuado

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 25, 2033. This may change due to patent challenges or generic licensing.

There are two tentative approvals for the generic drug (asenapine), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for SECUADO
International Patents:38
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
DailyMed Link:SECUADO at DailyMed
Drug patent expirations by year for SECUADO
Generic Entry Opportunity Date for SECUADO
Generic Entry Date for SECUADO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SYSTEM;TRANSDERMAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SECUADO

US Patents and Regulatory Information for SECUADO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 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 Y   Start Trial
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 RX Yes No   Start Trial   Start Trial   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 SECUADO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 10C0056 France   Start Trial PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.