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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 six 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-four suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the lamotrigine profile page.

Summary for NDA: 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 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 27, 1994TE:ABRLD:No
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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 27, 1994TE:ABRLD:No
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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 27, 1994TE:ABRLD:No
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 Orange Book Patents for NDA: 020241

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-005Dec 27, 19944,602,017*PED► subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-003Dec 27, 19944,602,017*PED► subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-002Dec 27, 19944,602,017*PED► subscribe
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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.

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