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Eslicarbazepine acetate - Generic Drug Details

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Eslicarbazepine acetate is the generic ingredient in one branded drug marketed by Sunovion Pharms Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-three patent family members in twenty-seven countries.

There are six drug master file entries for eslicarbazepine acetate. One supplier is listed for this compound.

Summary for Generic Name: eslicarbazepine acetate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: eslicarbazepine acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc
APTIOM
eslicarbazepine acetate
TABLET;ORAL022416-002Nov 8, 2013RXNo► subscribe► subscribe
Sunovion Pharms Inc
APTIOM
eslicarbazepine acetate
TABLET;ORAL022416-003Nov 8, 2013RXNo9,206,135► subscribeY ► subscribe
Sunovion Pharms Inc
APTIOM
eslicarbazepine acetate
TABLET;ORAL022416-004Nov 8, 2013RXYes► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: eslicarbazepine acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,288,532Asymmetric catalytic reduction of oxcarbazepine► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: eslicarbazepine acetate

Country Document Number Estimated Expiration
Denmark0751129► subscribe
Spain2562816► subscribe
South Korea20100093057► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ESLICARBAZEPINE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0040France► subscribePRODUCT 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
00406Netherlands► subscribePRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
C/GB09/047United Kingdom► subscribePRODUCT 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
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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 verifification 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.

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