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Last Updated: October 27, 2021

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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, Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Atlantide, Par Pharm, Rubicon, Torrent, Zydus Pharms, Ajanta Pharma Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Cipla, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa, and is included in fifty-one NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamotrigine has one hundred and thirteen patent family members in thirty-eight countries.

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

Summary for lamotrigine

International Patents:	113
US Patents:	5
Tradenames:	5
Applicants:	38
NDAs:	51
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	192
Patent Applications:	6,935
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
University College, London	Phase 3
Postgraduate Institute of Dental Sciences Rohtak	Phase 4
Brown University	Phase 2

See all lamotrigine clinical trials

Generic filers with tentative approvals for LAMOTRIGINE

Applicant	Application No.	Strength	Dosage Form
⤷ Try it Free	⤷ Try it Free	200MG	TABLET;ORAL
⤷ Try it Free	⤷ Try it Free	150MG	TABLET;ORAL
⤷ Try it Free	⤷ Try it Free	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	Mood Stabilizer Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for LAMOTRIGINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
LAMICTAL XR	TABLET, EXTENDED RELEASE;ORAL	lamotrigine	022115	2014-02-12
LAMICTAL ODT	TABLET, ORALLY DISINTEGRATING;ORAL	lamotrigine	022251	2009-12-21
LAMICTAL	TABLET;ORAL	lamotrigine	020241
LAMICTAL CD	TABLET, CHEWABLE;ORAL	lamotrigine	020764

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
Granules	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078982-001	Jan 27, 2009		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Actavis Elizabeth	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	200672-005	Oct 17, 2013	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Mylan Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078443-001	Feb 11, 2009		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>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 CD	lamotrigine	TABLET, CHEWABLE;ORAL	020764-004	Sep 8, 2000	⤷ Try it Free	⤷ Try it Free
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-006	Dec 27, 1994	⤷ Try it Free	⤷ Try it Free
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-003	Dec 27, 1994	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lamotrigine

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03068195	⤷ Try it Free
Hong Kong	1077003	⤷ Try it Free
Colombia	5680405	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.