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Last Updated: May 20, 2022

LAMICTAL XR Drug Patent 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-nine 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

See drug sales revenues for LAMICTAL XR

Recent Clinical Trials for LAMICTAL XR

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

SponsorPhase
Brown UniversityPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
The Searle Company LTD., Pakistan.Phase 1

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 two US patents.

Patents protecting LAMICTAL XR

Formulations and method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oral dosage form for controlled drug release
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-002 May 29, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-005 Apr 14, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-001 May 29, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-002 May 29, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for LAMICTAL XR

See the table below for patents covering LAMICTAL XR around the world.

Country Patent Number Title Estimated Expiration
Morocco 27509 FORMULATIONS A LIBERATION PROLONGEE CONTENANT DE LA LAMOTRIGINE See Plans and Pricing
Russian Federation 2325163 КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН (LAMOTRIGINE-BASED COMPOSITIONS OF PROLONGED RELEASE) See Plans and Pricing
Malaysia 141049 SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE See Plans and Pricing
Mexico PA04007794 FORMA DE DOSIFICACION ORAL PARA LA LIBERACION CONTROLADA DE UN FARMACO. (ORAL DOSAGE FORM FOR CONTROLLED DRUG RELEASE.) See Plans and Pricing
Ukraine 81756 ОРАЛЬНАЯ ДОЗИРОВАННАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА;ОРАЛЬНА ДОЗОВАНА ЛІКАРСЬКА ФОРМА ДЛЯ КОНТРОЛЬОВАНОГО ВИВІЛЬНЕННЯ ЛІКАРСЬКОГО ЗАСОБУ (Normal;heading 1;heading 2;CONTROLLED RELEASE ORAL DOSAGE FORM) See Plans and Pricing
Slovenia 1474114 See Plans and Pricing
Cyprus 1109119 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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