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Last Updated: July 16, 2020

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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 patent protection?

Oxcarbazepine is the generic ingredient in three branded drugs marketed by Amneal Pharms, Hikma, Sun Pharm Inds Ltd, Novartis, Supernus Pharms, Ani Pharms Inc, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Rubicon, Sun Pharm Inds, and Taro, and is included in fourteen 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 sixty patent family members in thirty-three countries.

There are twenty-one drug master file entries for oxcarbazepine. Eighteen 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
Eisai Inc.Phase 4
Weill Medical College of Cornell UniversityPhase 4
UCB Biopharma S.P.R.L.Phase 1

See all oxcarbazepine clinical trials

Generic filers with tentative approvals for OXCARBAZEPINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial150MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial600MGTABLET, 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 NDA Submissiondate
OXTELLAR XR TABLET, EXTENDED RELEASE;ORAL oxcarbazepine 202810 2013-04-12
OXTELLAR XR TABLET, EXTENDED RELEASE;ORAL oxcarbazepine 202810 2013-03-20
TRILEPTAL SUSPENSION;ORAL oxcarbazepine 021285 2006-12-26
TRILEPTAL TABLET;ORAL oxcarbazepine 021014 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
Sun Pharm Inds OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077794-003 Oct 9, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 201193-001 Oct 3, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc OXCARBAZEPINE oxcarbazepine TABLET;ORAL 078005-002 Dec 11, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc OXCARBAZEPINE oxcarbazepine TABLET;ORAL 078005-001 Dec 11, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
>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 SUSPENSION;ORAL 021285-001 May 25, 2001   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Merck
McKinsey
Boehringer Ingelheim
AstraZeneca

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