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LAMICTAL Drug Profile

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Lamictal is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. It is available from six suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in LAMICTAL is lamotrigine. There are thirty-two drug master file entries for this compound. Sixty-four suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the lamotrigine profile page.

Summary for Tradename: LAMICTAL

Patents:5
Applicants:1
NDAs:4
Suppliers / Packagers: see list6
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-003May 29, 2009RXNo8,637,512► subscribeY ► subscribe
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-001May 29, 2009RXNo9,144,547► subscribeY ► subscribe
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-004May 29, 2009RXYes8,637,512► subscribeY ► subscribe
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Expired Patents for Tradename: LAMICTAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-001Dec 27, 19944,602,017*PED► subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-005Dec 27, 19944,602,017*PED► subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-004Dec 27, 19944,602,017*PED► subscribe
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Paragraph IV activity for: LAMICTAL

Drugname Dosage Strength RLD Submissiondate
lamotrigineOrally Disintegrating Tablets25 mg, 50 mg, 100 mg, and 200 mgLamictal ODT12/21/2009
lamotrigineExtended-release Tablets25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mgLamictal XR2/12/2014
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