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Last Updated: April 19, 2024

Lamotrigine - Generic Drug Details

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What are the generic drug sources for lamotrigine and what is the scope of patent protection?

Lamotrigine is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamotrigine has forty-four patent family members in thirty countries.

There are thirty-two drug master file entries for lamotrigine. Fifty-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for lamotrigine

International Patents:	44
US Patents:	1
Tradenames:	5
Applicants:	42
NDAs:	53
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	209
Patent Applications:	6,968
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for lamotrigine
Drug Sales Revenues:	Drug sales revenues for lamotrigine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lamotrigine
What excipients (inactive ingredients) are in lamotrigine?	lamotrigine excipients list
DailyMed Link:	lamotrigine at DailyMed

See drug prices for lamotrigine

Drug Sales Revenue Trends for lamotrigine

See drug sales revenues for lamotrigine

Recent Clinical Trials for lamotrigine

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

Sponsor	Phase
Dr. Inge Winter	Phase 4
Westfälische Wilhelms-Universität Münster	Phase 4
Dr Cipto Mangunkusumo General Hospital	Phase 4

See all lamotrigine clinical trials

Generic filers with tentative approvals for LAMOTRIGINE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	25MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	200MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	150MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lamotrigine

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 LAMOTRIGINE

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
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 lamotrigine

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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	lamotrigine	TABLET;ORAL	020241-003	Dec 27, 1994	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	LAMOTRIGINE	lamotrigine	TABLET;ORAL	077420-004	Jan 27, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Elizabeth	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	200672-006	Nov 13, 2013	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078956-003	Jan 27, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	207763-003	Apr 1, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm	LAMOTRIGINE	lamotrigine	TABLET, ORALLY DISINTEGRATING;ORAL	204158-004	Oct 27, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva	LAMOTRIGINE	lamotrigine	TABLET;ORAL	076388-001	Aug 30, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 lamotrigine

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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	022115-003	May 29, 2009	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-002	Dec 27, 1994	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-006	Jun 21, 2011	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-003	Dec 27, 1994	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-001	May 29, 2009	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-002	Aug 24, 1998	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lamotrigine

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Country	Patent Number	Title	Estimated Expiration
New Zealand	537885	Sustained release formulations comprising a lamotrigine core and an outer coating	⤷ Try a Trial
Japan	4744142		⤷ Try a Trial
Hong Kong	1077003	SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE	⤷ Try a Trial
South Korea	100882707		⤷ Try a Trial
United Kingdom	0313801		⤷ Try a Trial
Israel	166424	SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE AND AN OUTER COATING WITH ONE OR MORE ORIFICES	⤷ Try a Trial
Russian Federation	2005105353	КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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