ASENAPINE - Generic Drug Details

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, Breckenridge, Sigmapharm Labs Llc, and Allergan, and is included in five NDAs. There are eight 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:	8
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	55
Patent Applications:	5,058
Drug Prices:	Drug price trends for ASENAPINE
What excipients (inactive ingredients) are in ASENAPINE?	ASENAPINE excipients list
DailyMed Link:	ASENAPINE at DailyMed

See drug prices for ASENAPINE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ASENAPINE

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.

Recent Clinical Trials for ASENAPINE

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

Sponsor	Phase
Lindner Center of HOPE	Phase 2
Patient-Centered Outcomes Research Institute
National Alliance on Mental Illness Montana

See all ASENAPINE clinical trials

Pharmacology for ASENAPINE

Drug Class

Atypical Antipsychotic

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
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No			Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	AB	RX	Yes	No					Y
Breckenridge	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	205960-003	Mar 8, 2021	AB	RX	No	No
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009	AB	RX	Yes	Yes					Y
Breckenridge	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	205960-001	Dec 10, 2020	AB	RX	No	No
Breckenridge	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	205960-002	Dec 10, 2020	AB	RX	No	No

EU/EMA Drug Approvals for ASENAPINE

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 ASENAPINE

Country	Patent Number	Title	Estimated Expiration
Portugal	2878300
South Korea	102013477
Japan	6067707
South Korea	102013478
Japan	6005742
Japan	6272418

Supplementary Protection Certificates for ASENAPINE

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