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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
Boehringer Ingelheim
Deloitte
Moodys
Medtronic
Fish and Richardson
Colorcon
Accenture
Farmers Insurance

Generated: December 15, 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 Amneal Pharms, Sun Pharm Inds Ltd, West-ward Pharms Int, Novartis, Supernus Pharms, Ani Pharms Inc, Apotex Inc, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, and Taro, 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-six suppliers are listed for this compound.

Pharmacology for oxcarbazepine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Supernus PharmsOXTELLAR XRoxcarbazepineTABLET, EXTENDED RELEASE;ORAL202810-002Oct 19, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Supernus PharmsOXTELLAR XRoxcarbazepineTABLET, EXTENDED RELEASE;ORAL202810-002Oct 19, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Supernus PharmsOXTELLAR XRoxcarbazepineTABLET, EXTENDED RELEASE;ORAL202810-003Oct 19, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Supernus PharmsOXTELLAR XRoxcarbazepineTABLET, EXTENDED RELEASE;ORAL202810-001Oct 19, 2012RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
West-ward Pharms IntOXCARBAZEPINEoxcarbazepineTABLET;ORAL077795-003Oct 9, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Supernus PharmsOXTELLAR XRoxcarbazepineTABLET, EXTENDED RELEASE;ORAL202810-003Oct 19, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm IndsOXCARBAZEPINEoxcarbazepineTABLET;ORAL077794-002Oct 9, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Supernus PharmsOXTELLAR XRoxcarbazepineTABLET, EXTENDED RELEASE;ORAL202810-001Oct 19, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Amneal PharmsOXCARBAZEPINEoxcarbazepineSUSPENSION;ORAL202961-001Sep 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Supernus PharmsOXTELLAR XRoxcarbazepineTABLET, EXTENDED RELEASE;ORAL202810-003Oct 19, 2012RXYesYes► Subscribe► 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
European Patent Office2359830► Subscribe
Germany602007012236► Subscribe
Czech Republic298840► Subscribe
Germany69814367► Subscribe
World Intellectual Property Organization (WIPO)2007127630► Subscribe
Hungary227807► Subscribe
Colombia4920215► Subscribe
World Intellectual Property Organization (WIPO)9835681► Subscribe
Israel131039► Subscribe
Russian Federation2201218► 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:

Mallinckrodt
Merck
Johnson and Johnson
UBS
US Department of Justice
Fish and Richardson
Moodys
Cantor Fitzgerald
Covington
Queensland Health

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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