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Last Updated: May 20, 2022

LAMICTAL ODT Drug Patent Profile


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

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

This drug has eighteen patent family members in thirteen countries.

The generic ingredient in LAMICTAL ODT 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 Odt

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

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

See drug prices for LAMICTAL ODT

Drug Sales Revenue Trends for LAMICTAL ODT

See drug sales revenues for LAMICTAL ODT

Recent Clinical Trials for LAMICTAL ODT

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

SponsorPhase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Brown UniversityPhase 2
University of KarachiPhase 1

See all LAMICTAL ODT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LAMICTAL ODT
Paragraph IV (Patent) Challenges for LAMICTAL ODT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LAMICTAL ODT Orally Disintegrating Tablets lamotrigine 25 mg, 50 mg, 100 mg, and 200 mg 022251 1 2009-12-21

US Patents and Regulatory Information for LAMICTAL ODT

LAMICTAL ODT is protected by three US patents.

Patents protecting LAMICTAL ODT

Orally disintegrating tablet compositions of lamotrigine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Orally disintegrating tablet compositions of lamotrigine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Orally disintegrating tablet compositions of lamotrigine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

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 ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-002 May 8, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No 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 ODT

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

Country Patent Number Title Estimated Expiration
Chile 2008001966 Composicion de disolucion oral que comprende lamotrigina,en forma de particulas con lamotrigina recubiertas con una capa para enmascarar el sabor y granulos que comprenden un desinfectante y un alcohol de azucar y/o un hidrato de carbono; metodo de preparacion;uso para tratar trastornos del humor y prevencion de ataques. See Plans and Pricing
Hong Kong 1201745 拉莫三嗪的口服崩解片劑組合物 (ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE) See Plans and Pricing
Uruguay 31205 COMPOSICIONES DE TABLETAS DE DESINTEGRACION ORAL DE LAMOTRIGINA See Plans and Pricing
China 104161733 Orally disintegrating tablet compositions of lamotrigine See Plans and Pricing
Taiwan 200911267 Orally disintegrating tablet compositions of lamotrigine See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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