LAMICTAL XR Drug Patent Profile

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When do Lamictal Xr patents expire, and when can generic versions of Lamictal Xr launch?

Lamictal Xr is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in thirty countries.

The generic ingredient in LAMICTAL XR is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lamictal Xr

A generic version of LAMICTAL XR was approved as lamotrigine by DR REDDYS LABS LTD on January 22^nd, 2009.

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Summary for LAMICTAL XR

International Patents:	44
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	94
Patent Applications:	4,969
Drug Prices:	Drug price information for LAMICTAL XR
Drug Sales Revenues:	Drug sales revenues for LAMICTAL XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LAMICTAL XR
DailyMed Link:	LAMICTAL XR at DailyMed

Drug patent expirations by year for LAMICTAL XR

Recent Clinical Trials for LAMICTAL XR

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Brown University	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2

See all LAMICTAL XR clinical trials

Pharmacology for LAMICTAL XR

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

Paragraph IV (Patent) Challenges for LAMICTAL XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LAMICTAL XR	Extended-release Tablets	lamotrigine	25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg	022115	1	2014-02-12

US Patents and Regulatory Information for LAMICTAL XR

LAMICTAL XR is protected by one US patents.

Patents protecting LAMICTAL XR

Formulations and method of treatment
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Glossary

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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 XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-002	May 29, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-003	May 29, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-005	Apr 14, 2010	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-006	Jun 21, 2011	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for LAMICTAL XR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-006	Jun 21, 2011	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-005	Apr 14, 2010	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-003	May 29, 2009	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-002	May 29, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LAMICTAL XR

See the table below for patents covering LAMICTAL XR around the world.

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Country	Patent Number	Title	Estimated Expiration
China	101229169	Sustained release formulations comprising lamotrigine	⤷ Sign Up
United Kingdom	0203298		⤷ Sign Up
Russian Federation	2007143372	КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН	⤷ Sign Up
Norway	20043633		⤷ Sign Up
Russian Federation	2005105353	КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН	⤷ Sign Up
China	100363007		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004012741		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration