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Last Updated: June 19, 2021

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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 one Paragraph IV challenge.

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

DrugPatentWatch® 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

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

SponsorPhase
Brown UniversityPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
ClinPharmInvest, LLCPhase 1

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   Get Started Free   Get Started Free Y   Get Started Free
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-005 Apr 14, 2010 AB RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-005 Dec 27, 1994 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-003 May 29, 2009 AB RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-004 Sep 8, 2000 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
>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

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Medtronic
Colorcon
Boehringer Ingelheim
Johnson and Johnson

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