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
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 |

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
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes 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 |