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Last Updated: September 29, 2023

Lamotrigine - Generic Drug Details

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What are the generic drug sources for lamotrigine and what is the scope of freedom to operate?

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 are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for lamotrigine

International Patents:	95
US Patents:	2
Tradenames:	5
Applicants:	42
NDAs:	53
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	56
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	209
Patent Applications:	7,177
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
Westfälische Wilhelms-Universität Münster	Phase 4
Dr. Inge Winter	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	200MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	150MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	100MG	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

Anatomical Therapeutic Chemical (ATC) Classes for lamotrigine

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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
Teva	LAMOTRIGINE	lamotrigine	TABLET, FOR SUSPENSION;ORAL	076420-001	Jun 21, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rubicon	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	202887-002	Jun 17, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	202383-006	Sep 6, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078956-002	Jan 27, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-003	Dec 27, 1994	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Elizabeth	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	200672-001	Oct 17, 2013	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Unichem Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET;ORAL	090170-002	Oct 6, 2011	AB	RX	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	lamotrigine	TABLET;ORAL	020241-005	Dec 27, 1994	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000	⤷ 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	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 XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-004	May 29, 2009	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-003	Dec 27, 1994	⤷ 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
Mexico	PA04007794	FORMA DE DOSIFICACION ORAL PARA LA LIBERACION CONTROLADA DE UN FARMACO. (ORAL DOSAGE FORM FOR CONTROLLED DRUG RELEASE.)	⤷ Try a Trial
Russian Federation	2325163	КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН (LAMOTRIGINE-BASED COMPOSITIONS OF PROLONGED RELEASE)	⤷ Try a Trial
Malaysia	141049	SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE	⤷ Try a Trial
Germany	60326590		⤷ Try a Trial
Poland	371368		⤷ Try a Trial
China	100444833		⤷ Try a Trial
Colombia	5680405	FORMULACION DE LAMOTRIGINA DE LIBERACION PROLONGADA Y USO DE LA MISMA PARA SU PREPARACION	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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