Is there a generic for Lamotrigine?

Yes. The FDA Orange Book lists 54 approved generic (ANDA) applications for Lamotrigine, referencing the brand SUBVENITE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lamotrigine?

SUBVENITE (NDA 218879, OWP PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Lamotrigine?

The Orange Book lists 3 patents against Lamotrigine products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Lamotrigine are approved?

Lamotrigine is approved in the following dosage forms: suspension, tablet, tablet, extended release, tablet, for suspension, tablet, orally disintegrating.

FDA Orange Book · active-ingredient family

Lamotrigine

Lamotrigine: 5 brands, 54 generics; first approved Dec 27, 1994; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 54 ANDA applications approved.

Earliest patent expiry Jan 07, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 07, 2029

in 2 yr 6 mo

Originator applications

Brand (NDA) products

SUBVENITERLDRS

OWP PHARMSNDA 2188792025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	SUSPENSION	ORAL	Rx	—

LAMICTAL XRRLD

GLAXOSMITHKLINE LLCNDA 02211520096 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
100MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
200MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
300MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
250MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

LAMICTAL ODTRLD

GLAXOSMITHKLINE LLCNDA 02225120094 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
50MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
100MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB
200MG	TABLET, ORALLY DISINTEGRATING	ORAL	Rx	AB

LAMICTAL CDRLD

GLAXOSMITHKLINE LLCNDA 02076420004 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
25MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
100MG	TABLET, FOR SUSPENSION	ORAL	Discontinued	—
2MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

LAMICTALRLDRS

GLAXOSMITHKLINE LLCNDA 02024119946 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	AB
150MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB
250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
25MG	TABLET	ORAL	Rx	AB
50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

Abbreviated applications

Patent	Expires	In	Type
8637512	Jan 07, 2029	in 2 yr 6 mo	Product
11596634	May 29, 2040	in 14 yr 1 mo	U-4271
11612566	May 29, 2040	in 14 yr 1 mo	U-4271

Lamotrigine

Brand (NDA) products

Generic (ANDA) products (54)

Patent & exclusivity timeline

Listed patents

Listed patents (3)

Approval history

Lamotrigine — frequently asked questions

Is there a generic for Lamotrigine?

What is the reference-listed drug for Lamotrigine?

What patents protect Lamotrigine?

What dosage forms of Lamotrigine are approved?

Related FDA reference tools

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