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Last Updated: August 15, 2020

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OXCARBAZEPINE Drug Profile

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When do Oxcarbazepine patents expire, and what generic alternatives are available?

Oxcarbazepine is a drug marketed by Amneal Pharms, Hikma, Sun Pharm Inds Ltd, Ani Pharms Inc, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Rubicon, Sun Pharm Inds, and Taro. and is included in eleven NDAs.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

US ANDA Litigation and Generic Entry Outlook for Oxcarbazepine

A generic version of OXCARBAZEPINE was approved as oxcarbazepine by GLENMARK PHARMS LTD on October 9th, 2007.

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Drug patent expirations by year for OXCARBAZEPINE
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
Weill Medical College of Cornell UniversityPhase 4
Eisai Inc.Phase 4
UCB Biopharma S.P.R.L.Phase 1

See all OXCARBAZEPINE clinical trials

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
Amneal Pharms OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 202961-001 Sep 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Cadista OXCARBAZEPINE oxcarbazepine TABLET;ORAL 090239-003 Jan 25, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077794-003 Oct 9, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge Pharm OXCARBAZEPINE oxcarbazepine TABLET;ORAL 078069-001 Jan 11, 2008 AB RX 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

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

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