Lamotrigine - Generic Drug Details

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 Pharms Ltd, 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, Alkem Labs Ltd, Cipla, 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. Forty-eight 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:	41
NDAs:	53
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	205
Patent Applications:	7,269
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

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
Region Capital Denmark	N/A

See all lamotrigine clinical trials

Generic filers with tentative approvals for LAMOTRIGINE

Applicant	Application No.	Strength	Dosage Form
		25MG	TABLET;ORAL
		200MG	TABLET;ORAL
		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	201791-005	Jan 18, 2013	AB	RX	No	No
Taro Pharm Inds	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078525-002	Jan 27, 2009	AB	RX	No	No
Rising	LAMOTRIGINE	lamotrigine	TABLET;ORAL	077420-004	Jan 27, 2009		DISCN	No	No
Dr Reddys Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	202383-006	Sep 6, 2018	AB	RX	No	No
Unichem Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET;ORAL	090170-003	Oct 6, 2011	AB	RX	No	No
Mylan Labs Ltd	LAMOTRIGINE	lamotrigine	TABLET;ORAL	078443-001	Feb 11, 2009		DISCN	No	No

Expired US Patents for lamotrigine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-004	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-002	Aug 24, 1998
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-004	Sep 8, 2000
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-005	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL	lamotrigine	TABLET;ORAL	020241-006	Dec 27, 1994
Glaxosmithkline Llc	LAMICTAL CD	lamotrigine	TABLET, FOR SUSPENSION;ORAL	020764-003	Aug 24, 1998

International Patents for lamotrigine

Country	Patent Number	Title	Estimated Expiration
Portugal	1524981
Malaysia	141049	SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE
United Kingdom	0313801
Japan	2010159301	ORAL DOSAGE FORM FOR CONTROLLED DRUG RELEASE
Morocco	27689
China	1681509	Slow release preparation containing larmotriazine