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APTIOM Drug Profile

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Which patents cover Aptiom, and when can generic versions of Aptiom launch?

Aptiom is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventeen patent family members in thirty countries.

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

Summary for APTIOM

International Patents:	117
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	54
Clinical Trials:	3
Patent Applications:	48
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for APTIOM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APTIOM
DailyMed Link:	APTIOM at DailyMed

Generic Entry Opportunity Date for APTIOM

NDA:

022416

Dosage:

TABLET;ORAL

^*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 APTIOM

Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for APTIOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunovion Pharms Inc	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013		RX	Yes	Yes				Y
Sunovion Pharms Inc	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013		RX	Yes	No
Sunovion Pharms Inc	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013		RX	Yes	No			Y
Sunovion Pharms Inc	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013		RX	Yes	No			Y
Sunovion Pharms Inc	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013		RX	Yes	No			Y	Y
Sunovion Pharms Inc	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013		RX	Yes	No			Y

Paragraph IV (Patent) Challenges for APTIOM

Drugname	Dosage	Strength	RLD	Date
	Tablets	200 mg, 400 mg, 600 mg and 800 mg

International Patents for APTIOM

Country	Document Number	Estimated Expiration
Hungary	221382
Japan	2017014233
Argentina	064898
Australia	2006273874
Cyprus	1118350
Spain	2607002

Supplementary Protection Certificates for APTIOM

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB09/047	United Kingdom		PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTERED: UK EU/1/09/514/001 20090421; UK EU/1/09/514/002 20090421; UK EU/1/09/514/003 20090421; UK EU/1/09/514/004 20090421; UK EU/1/09/514/005 20090421; UK EU/1/09/514/006 20090421; UK EU/1/09/514/019 20090421; UK EU/1/09/514/020 20090421; UK EU/1/09/514/013 20090421; UK EU/1/09/514/014 20090421; UK EU/1/09/514/015 20090421; UK EU/1/09/514/016 20090421; UK EU/1/09/514/017 20090421; UK EU/1/09/514/018 20090421; UK EU/1/09/514/007 20090421; UK EU/1/09/514/008 20090421; UK EU/1/09/514/009 20090421; UK EU/1/09/514/010 20090421; UK EU/1/09/514/011 20090421; UK EU/1/09/514/012 20090421
0	Finland
2009 00023	Denmark
C0040	France		PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/514/001 DU 20090421; REGISTRATION NO/DATE AT EEC: EU/1/09/514/001 DU 20090421
00406	Netherlands		PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
C027/2009	Ireland		SPC027/2009: 20091119, EXPIRES: 20210627