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Last Updated: January 21, 2021

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LAMICTAL ODT Drug Profile

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When do Lamictal Odt patents expire, and when can generic versions of Lamictal Odt launch?

Lamictal Odt is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in thirteen countries.

The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Additional details are available on the lamotrigine profile page.

US ANDA Litigation and Generic Entry Outlook for Lamictal Odt

A generic version of LAMICTAL ODT was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.

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Drug patent expirations by year for LAMICTAL ODT
Drug Prices for LAMICTAL ODT

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Drug Sales Revenue Trends for LAMICTAL ODT

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Recent Clinical Trials for LAMICTAL ODT

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

SponsorPhase
Pharmtechnology LLCPhase 1
ClinPharmInvest, LLCPhase 1
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all LAMICTAL ODT clinical trials

Paragraph IV (Patent) Challenges for LAMICTAL ODT
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL ODT TABLET, ORALLY DISINTEGRATING;ORAL lamotrigine 022251 2009-12-21

US Patents and Regulatory Information for LAMICTAL ODT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-002 May 8, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No   Start Trial   Start Trial Y   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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