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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022115

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NDA 022115 describes LAMICTAL XR, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LAMICTAL XR profile page.

The generic ingredient in LAMICTAL XR is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 022115
Tradename:LAMICTAL XR
Applicant:Glaxosmithkline Llc
Ingredient:lamotrigine
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022115
Suppliers and Packaging for NDA: 022115
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115 NDA GlaxoSmithKline LLC 0173-0754 0173-0754-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0754-00)
LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115 NDA GlaxoSmithKline LLC 0173-0755 0173-0755-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0755-00)
Paragraph IV (Patent) Challenges for 022115
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL XR TABLET, EXTENDED RELEASE;ORAL lamotrigine 022115 2014-02-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:May 29, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 14, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 22, 2023Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG
Approval Date:May 29, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 14, 2028Product Flag?YSubstance Flag?Delist Request?

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