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Last Updated: August 14, 2020

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LAMICTAL Drug Profile

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

Lamictal is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

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

US ANDA Litigation and Generic Entry Outlook for Lamictal

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

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Drug patent expirations by year for LAMICTAL
Drug Prices for LAMICTAL

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Drug Sales Revenue Trends for LAMICTAL

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Recent Clinical Trials for LAMICTAL

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

See all LAMICTAL clinical trials

Paragraph IV (Patent) Challenges for LAMICTAL
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL TABLET;ORAL lamotrigine 020241

US Patents and Regulatory Information for LAMICTAL

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 XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-006 Jun 21, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-005 Apr 14, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-005 Dec 27, 1994 AB RX Yes Yes   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 LAMICTAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-004 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-005 Dec 27, 1994   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-001 Dec 27, 1994   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:

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