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Last Updated: July 2, 2020

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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 seven 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
Applicant:Sunovion Pharms Inc
Ingredient:eslicarbazepine acetate
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022416
Generic Entry Date for 022416*:
Constraining patent/regulatory exclusivity:

*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.

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)
Paragraph IV (Patent) Challenges for 022416
Tradename Dosage Ingredient NDA Submissiondate
APTIOM TABLET;ORAL eslicarbazepine acetate 022416 2017-11-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 8, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 27, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Apr 17, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 21, 2026Product Flag?Substance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.