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Generated: October 20, 2017

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Oxcarbazepine - Generic Drug Details

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What are the generic drug sources for oxcarbazepine and what is the scope of oxcarbazepine patent protection?

Oxcarbazepine
is the generic ingredient in three branded drugs marketed by Taro, Glenmark Pharms Ltd, Ani Pharms Inc, Supernus Pharms, Novartis, Sun Pharm Inds Ltd, Jubilant Cadista, Apotex Inc, Amneal Pharms, Breckenridge Pharm, West-ward Pharms Int, and Sun Pharm Inds, and is included in fourteen NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxcarbazepine has fifty-nine patent family members in thirty-four countries.

There are nineteen drug master file entries for oxcarbazepine. Twenty-seven suppliers are listed for this compound.

Summary for Generic Name: oxcarbazepine

US Patents:9
Tradenames:3
Applicants:12
NDAs:14
Drug Master File Entries: see list19
Suppliers / Packagers: see list27
Bulk Api Vendors: see list59
Clinical Trials: see list54
Patent Applications: see list4,536
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxcarbazepine at DailyMed

Pharmacology for Ingredient: oxcarbazepine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms
OXTELLAR XR
oxcarbazepine
TABLET, EXTENDED RELEASE;ORAL202810-001Oct 19, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL077794-003Oct 9, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL077747-003Apr 9, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Supernus Pharms
OXTELLAR XR
oxcarbazepine
TABLET, EXTENDED RELEASE;ORAL202810-001Oct 19, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Ani Pharms Inc
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL078005-001Dec 11, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Supernus Pharms
OXTELLAR XR
oxcarbazepine
TABLET, EXTENDED RELEASE;ORAL202810-001Oct 19, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Jubilant Cadista
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL090239-003Jan 25, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL077795-001Oct 9, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Taro
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL077801-001Nov 15, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms Ltd
OXCARBAZEPINE
oxcarbazepine
TABLET;ORAL077802-001Oct 9, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: oxcarbazepine

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
8,017,149Modified release preparations containing oxcarbazepine and derivatives thereof► Subscribe
9,119,792Modified release preparations containing oxcarbazepine and derivatives thereof► Subscribe
8,211,464Modified release preparations containing oxcarbazepine and derivatives thereof► 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: oxcarbazepine

Country Document Number Estimated Expiration
Germany69814367► Subscribe
World Intellectual Property Organization (WIPO)9835681► Subscribe
Poland193332► Subscribe
Canada2597740► Subscribe
Cyprus2480► Subscribe
China1626093► Subscribe
China101489560► Subscribe
New Zealand336946► Subscribe
South Africa9801205► Subscribe
Argentina011142► 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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Serving leading biopharmaceutical companies globally:

Accenture
McKinsey
Daiichi Sankyo
Chubb
Teva
Baxter
McKesson
Federal Trade Commission
Covington
US Army

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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