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Last Updated: January 26, 2021

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LAMICTAL XR Drug Profile

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

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

This drug has ninety-five patent family members in thirty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Lamictal Xr

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

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

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Drug Sales Revenue Trends for LAMICTAL XR

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Recent Clinical Trials for LAMICTAL XR

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 XR clinical trials

Paragraph IV (Patent) Challenges for LAMICTAL XR
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL XR TABLET, EXTENDED RELEASE;ORAL lamotrigine 022115 2014-02-12

US Patents and Regulatory Information for LAMICTAL XR

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 022115-001 May 29, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-002 May 29, 2009 AB RX Yes Yes   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 XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 AB RX Yes Yes   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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