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Last Updated: June 27, 2022

Details for New Drug Application (NDA): 022416


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NDA 022416 describes APTIOM, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are ten 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. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for 022416
Tradename:APTIOM
Applicant:Sunovion Pharms Inc
Ingredient:eslicarbazepine acetate
Patents:10
Formulation / Manufacturing:see details
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 Sunovion Pharmaceuticals 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 Sunovion Pharmaceuticals Inc. 63402-202 63402-202-30 30 TABLET in 1 BOTTLE (63402-202-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 8, 2013TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:May 6, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES
Patent:See Plans and PricingPatent Expiration:May 6, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
Patent:See Plans and PricingPatent Expiration:May 6, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES

Expired US Patents for NDA 022416

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-002 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-001 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-003 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc APTIOM eslicarbazepine acetate TABLET;ORAL 022416-004 Nov 8, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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