SECUADO Drug Patent Profile

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

NDA:

212268

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

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for SECUADO

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

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

FDA Regulatory Exclusivity protecting 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	Yes			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-001	Oct 11, 2019		RX	Yes	Yes			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No

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

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

European Patent Office

Japan

Poland

Portugal

South Korea

Spain

Taiwan

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
Japan	2017025111	貼付剤 (MEDICAL PATCH)
World Intellectual Property Organization (WIPO)	2014017594
European Patent Office	2878298	TIMBRE ADHÉSIF ET SON PROCÉDÉ DE FABRICATION (ADHESIVE PATCH AND PRODUCTION METHOD THEREFOR)
South Korea	102013477

Supplementary Protection Certificates for SECUADO

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