Details for New Drug Application (NDA): 022416

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NDA 022416 describes APTIOM, which is a drug marketed by Sumitomo Pharma Am and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the APTIOM profile page.

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

Summary for 022416

Tradename:	APTIOM
Applicant:	Sumitomo Pharma Am
Ingredient:	eslicarbazepine acetate
Patents:	11

Pharmacology for NDA: 022416

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

Suppliers and Packaging for NDA: 022416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416	NDA	Sumitomo Pharma America, Inc.	63402-202	63402-202-28	4 BLISTER PACK in 1 CARTON (63402-202-28) / 7 TABLET in 1 BLISTER PACK (63402-202-07)
APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416	NDA	Sumitomo Pharma America, Inc.	63402-202	63402-202-30	30 TABLET in 1 BOTTLE (63402-202-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Nov 8, 2013	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	May 6, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PARTIAL-ONSET SEIZURES
Patent:	⤷ Sign Up	Patent Expiration:	May 6, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
Patent:	⤷ Sign Up	Patent Expiration:	May 6, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PARTIAL-ONSET SEIZURES

Expired US Patents for NDA 022416

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	⤷ Sign Up	⤷ Sign Up
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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