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Last Updated: August 14, 2022

SECUADO Drug Patent 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 five 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.

DrugPatentWatch® 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.

Indicators of Generic Entry

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Summary for SECUADO
International Patents:38
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in SECUADO?SECUADO excipients list
DailyMed Link:SECUADO at DailyMed
Drug patent expirations by year for SECUADO
DrugPatentWatch® Estimated 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

SECUADO is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SECUADO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SECUADO

Patch
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Patch
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH

Patch and method for producing the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH

Patch
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Patch
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting SECUADO

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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 Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-003 Oct 11, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-002 Oct 11, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-002 Oct 11, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for SECUADO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
N.V. Organon Sycrest asenapine EMEA/H/C/001177
Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Authorised no no no 2010-09-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SECUADO

When does loss-of-exclusivity occur for SECUADO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

Patent: 4487071
Estimated Expiration: See Plans and Pricing

Patent: 4487072
Estimated Expiration: See Plans and Pricing

Patent: 4507472
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 78298
Estimated Expiration: See Plans and Pricing

Patent: 78299
Estimated Expiration: See Plans and Pricing

Patent: 78300
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2014017593
Estimated Expiration: See Plans and Pricing

Patent: 2014017594
Estimated Expiration: See Plans and Pricing

Patent: 2014017595
Estimated Expiration: See Plans and Pricing

Patent: 05741
Estimated Expiration: See Plans and Pricing

Patent: 05742
Estimated Expiration: See Plans and Pricing

Patent: 67707
Estimated Expiration: See Plans and Pricing

Patent: 72418
Estimated Expiration: See Plans and Pricing

Patent: 86011
Estimated Expiration: See Plans and Pricing

Patent: 16199603
Estimated Expiration: See Plans and Pricing

Patent: 17025111
Estimated Expiration: See Plans and Pricing

Poland

Patent: 78299
Estimated Expiration: See Plans and Pricing

Patent: 78300
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 78299
Estimated Expiration: See Plans and Pricing

Patent: 78300
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2013476
Estimated Expiration: See Plans and Pricing

Patent: 2013477
Estimated Expiration: See Plans and Pricing

Patent: 2013478
Estimated Expiration: See Plans and Pricing

Patent: 150036477
Estimated Expiration: See Plans and Pricing

Patent: 150036478
Estimated Expiration: See Plans and Pricing

Patent: 150036479
Estimated Expiration: See Plans and Pricing

Spain

Patent: 32946
Estimated Expiration: See Plans and Pricing

Patent: 33974
Estimated Expiration: See Plans and Pricing

Patent: 81034
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 92170
Estimated Expiration: See Plans and Pricing

Patent: 94771
Estimated Expiration: See Plans and Pricing

Patent: 03748
Estimated Expiration: See Plans and Pricing

Patent: 1410270
Estimated Expiration: See Plans and Pricing

Patent: 1410271
Estimated Expiration: See Plans and Pricing

Patent: 1410272
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SECUADO around the world.

Country Patent Number Title Estimated Expiration
Portugal 2878300 See Plans and Pricing
Japan 2017025111 貼付剤 (MEDICAL PATCH) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014017594 See Plans and Pricing
European Patent Office 2878298 TIMBRE ADHÉSIF ET SON PROCÉDÉ DE FABRICATION (ADHESIVE PATCH AND PRODUCTION METHOD THEREFOR) See Plans and Pricing
South Korea 102013477 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SECUADO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 10C0056 France See Plans and Pricing PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317 C300461 Netherlands See Plans and Pricing 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 See Plans and Pricing 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

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Serving leading biopharmaceutical companies globally:

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McKinsey
Harvard Business School
Medtronic
Johnson and Johnson
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.