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Merck
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QuintilesIMS
US Department of Justice
Queensland Health
Express Scripts
US Army
Cantor Fitzgerald
Mallinckrodt

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020241

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NDA 020241 describes LAMICTAL, which is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. It is available from two suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LAMICTAL profile page.

The generic ingredient in LAMICTAL is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 020241
Tradename:LAMICTAL
Applicant:Glaxosmithkline Llc
Ingredient:lamotrigine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020241
Suppliers and Packaging for NDA: 020241
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL lamotrigine TABLET;ORAL 020241 NDA GlaxoSmithKline LLC 0173-0594 N 0173-0594-02
LAMICTAL lamotrigine TABLET;ORAL 020241 NDA GlaxoSmithKline LLC 0173-0633 N 0173-0633-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 27, 1994TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 27, 1994TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 27, 1994TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY

Expired US Patents for NDA 020241

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-003 Dec 27, 1994 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-004 Dec 27, 1994 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-001 Dec 27, 1994 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-006 Dec 27, 1994 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Teva
Moodys
Mallinckrodt
AstraZeneca
Boehringer Ingelheim
Daiichi Sankyo
Cipla
Federal Trade Commission

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