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Last Updated: March 29, 2024

LAMICTAL XR Drug Patent Profile


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

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

This drug has forty-four patent family members in thirty countries.

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

DrugPatentWatch® 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
Dr Cipto Mangunkusumo General HospitalPhase 4
Brown UniversityPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2

See all LAMICTAL XR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LAMICTAL XR
Paragraph IV (Patent) Challenges for LAMICTAL XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LAMICTAL XR Extended-release Tablets lamotrigine 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg 022115 1 2014-02-12

US Patents and Regulatory Information for LAMICTAL XR

LAMICTAL XR is protected by one US patents.

Patents protecting LAMICTAL XR

Formulations and method of treatment
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Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-002 May 29, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-001 May 29, 2009 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-005 Apr 14, 2010 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-002 May 29, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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