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Last Updated: January 30, 2023

Oxcarbazepine - Generic Drug Details


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

Oxcarbazepine is the generic ingredient in three branded drugs marketed by Akorn, Amneal Pharms, Aucta, Bionpharma Inc, Glasshouse Pharms, Hikma, Rubicon, Sun Pharm Inds Ltd, Novartis, Supernus Pharms, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, and Taro, and is included in twenty NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxcarbazepine has fourteen patent family members in ten countries.

There are twenty-one drug master file entries for oxcarbazepine. Twenty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for oxcarbazepine

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Drug Sales Revenue Trends for oxcarbazepine

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Recent Clinical Trials for oxcarbazepine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Postgraduate Institute of Dental Sciences RohtakPhase 4
Boston Children’s HospitalPhase 3
Boston Children's HospitalPhase 3

See all oxcarbazepine clinical trials

Generic filers with tentative approvals for OXCARBAZEPINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing150MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing600MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing300MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for oxcarbazepine
Paragraph IV (Patent) Challenges for OXCARBAZEPINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OXTELLAR XR Extended-release Tablets oxcarbazepine 150 mg and 300 mg 202810 1 2013-04-12
OXTELLAR XR Extended-release Tablets oxcarbazepine 600 mg 202810 1 2013-03-20
TRILEPTAL Oral Suspension oxcarbazepine 300 mg/5 mL 021285 1 2006-12-26
TRILEPTAL Tablets oxcarbazepine 150 mg, 300 mg and 600 mg 021014 1 2006-05-05

US Patents and Regulatory Information for 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;ORAL 202810-001 Oct 19, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-002 Oct 19, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-001 Oct 19, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-003 Oct 19, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-003 Oct 19, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for oxcarbazepine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000 See Plans and Pricing See Plans and Pricing
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 See Plans and Pricing See Plans and Pricing
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 See Plans and Pricing See Plans and Pricing
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000 See Plans and Pricing See Plans and Pricing
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxcarbazepine

Country Patent Number Title Estimated Expiration
Mexico 2008013675 PREPARACIONES DE LIBERACION CONTROLADA DE OXCARBACEPINA QUE TIENEN PERFIL DE LIBERACION SIGMOIDAL. (CONTROLLED RELEASED PREPARATIONS OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE.) See Plans and Pricing
Spain 2360423 See Plans and Pricing
Japan 2009535351 See Plans and Pricing
Japan 2013079267 CONTROLLED RELEASED PREPARATION OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE See Plans and Pricing
Austria 496623 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.