Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Dow
UBS
Chinese Patent Office
Chubb
Fish and Richardson
Merck
Teva

Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020241

« Back to Dashboard

NDA 020241 describes LAMICTAL, which is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. It is available from four 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. Sixty-two 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
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 0173-0594-02 1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0594-02) > 1 KIT in 1 BLISTER PACK
LAMICTAL lamotrigine TABLET;ORAL 020241 NDA GlaxoSmithKline LLC 0173-0633 0173-0633-02 100 TABLET in 1 BOTTLE (0173-0633-02)

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 020241-005 Dec 27, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-002 Dec 27, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-003 Dec 27, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Cipla
Medtronic
Healthtrust
Dow
Moodys
McKesson
Merck
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.