LAMICTAL XR Drug Patent Profile

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 are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-five patent family members in thirty-eight countries.

The generic ingredient in LAMICTAL XR 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 Xr

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

Summary for LAMICTAL XR

International Patents:	95
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	92
Patent Applications:	4,295
Formulation / Manufacturing:	see details
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

See drug prices for LAMICTAL XR

See drug sales revenues for LAMICTAL XR

Recent Clinical Trials for LAMICTAL XR

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

Sponsor	Phase
Brown University	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
The Searle Company LTD., Pakistan.	Phase 1

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

Anatomical Therapeutic Chemical (ATC) Classes for LAMICTAL XR

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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 two US patents.

Patents protecting LAMICTAL XR

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			Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	AB	RX	Yes	Yes			Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-002	May 29, 2009	AB	RX	Yes	Yes			Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-005	Apr 14, 2010	AB	RX	Yes	No			Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	AB	RX	Yes	Yes			Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009	AB	RX	Yes	No			Y
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-002	May 29, 2009	AB	RX	Yes	Yes			Y

International Patents for LAMICTAL XR

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

Country	Patent Number	Title	Estimated Expiration
Morocco	27509	FORMULATIONS A LIBERATION PROLONGEE CONTENANT DE LA LAMOTRIGINE
Russian Federation	2325163	КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН (LAMOTRIGINE-BASED COMPOSITIONS OF PROLONGED RELEASE)
Malaysia	141049	SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE
Mexico	PA04007794	FORMA DE DOSIFICACION ORAL PARA LA LIBERACION CONTROLADA DE UN FARMACO. (ORAL DOSAGE FORM FOR CONTROLLED DRUG RELEASE.)
Ukraine	81756	ОРАЛЬНАЯ ДОЗИРОВАННАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА;ОРАЛЬНА ДОЗОВАНА ЛІКАРСЬКА ФОРМА ДЛЯ КОНТРОЛЬОВАНОГО ВИВІЛЬНЕННЯ ЛІКАРСЬКОГО ЗАСОБУ (Normal;heading 1;heading 2;CONTROLLED RELEASE ORAL DOSAGE FORM)
Slovenia	1474114
Cyprus	1109119