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APTIOM Drug Profile

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When do Aptiom patents expire, and what generic alternatives are available?

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 nineteen 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:	119
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	56
Clinical Trials:	3
Patent Applications:	51
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

Synonyms for APTIOM

(10S)-10-(Acetyloxy)-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide

(10S)-10-acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide

(10S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate

(S)-(-)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide

(S)-5-Carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate

[(5S)-11-carbamoyl-5,6-dihydrobenzo[b][1]benzazepin-5-yl] acetate

10-Acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide

10S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate

236395-14-5

5H-Dibenz[b,f]azepine-5-carboxamide,10-(acetyloxy)-10,11-dihydro-, (10S)-

5H-Dibenz9b,f)azepine-5-carboxamide, 10-(acetyloxy)-10,11-dihydro-, (10S)-

AC1L452K

Acetic acid (S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl ester

Acetic acid 5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10(S)-yl ester

AK163092

AKOS005145781

AN-6410

Aptiom (TN)

AS-14058

AX8243774

BDBM50240669

BEA68ZVB2K

BIA 2-093

BIA 2-093, >=98% (HPLC), solid

BIA 2093

BIA-2-093

CCG-222406

CHEBI:87016

CHEMBL87992

CS-2942

CTK4F1953

D09612

DB09119

DTXSID90178308

E1046

Eslicarbazapine Acetate

Eslicarbazepine (acetate)

Eslicarbazepine acetate

Eslicarbazepine acetate (USAN)

Eslicarbazepine acetate [USAN]

Exalief

exelief

FT-0667969

HMS3263M06

HY-B0703

J-015175

J90004

KS-00000QYO

LP01102

MolPort-005-942-413

NCGC00165752-01

NCGC00165752-02

NCGC00261787-01

QIALRBLEEWJACW-INIZCTEOSA-N

RT-011499

S-(-)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide

s4657

SB18907

SCHEMBL250594

SEP - 0002093

Sep 0002093

SEP-0002093

ST24036220

Stedesa

Tox21_501102

UNII-BEA68ZVB2K

X5819

Zebinix

Zebinix (TN)

ZINC7295

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	022416-004	Nov 8, 2013		RX	Yes	Yes			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	022416-003	Nov 8, 2013		RX	Yes	No

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	Patent Number	Estimated Expiration
Lithuania	2121138
Poland	2121138
Russian Federation	2488397
Poland	185476

Supplementary Protection Certificates for APTIOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0751129	09C0040	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
0751129	SPC/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
0751129	CA 2009 00023	Denmark
0751129	360	Finland