LAMICTAL ODT Drug Patent Profile

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 22^nd, 2009.

Summary for LAMICTAL ODT

International Patents:	18
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	92
Patent Applications:	4,421
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LAMICTAL ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LAMICTAL ODT
DailyMed Link:	LAMICTAL ODT at DailyMed

See drug prices for LAMICTAL ODT

See drug sales revenues for LAMICTAL ODT

Recent Clinical Trials for LAMICTAL ODT

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

Sponsor	Phase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
Brown University	Phase 2
University of Karachi	Phase 1

See all LAMICTAL ODT clinical trials

Pharmacology for LAMICTAL ODT

Drug Class	Anti-epileptic Agent Mood Stabilizer
Mechanism of Action	Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for LAMICTAL ODT

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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

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

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.
Hong Kong	1201745	拉莫三嗪的口服崩解片劑組合物 (ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE)
Uruguay	31205	COMPOSICIONES DE TABLETAS DE DESINTEGRACION ORAL DE LAMOTRIGINA
China	104161733	Orally disintegrating tablet compositions of lamotrigine
Taiwan	200911267	Orally disintegrating tablet compositions of lamotrigine