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Federal Trade Commission
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Generated: December 13, 2017

DrugPatentWatch Database Preview

LAMICTAL Drug Profile

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When do Lamictal patents expire, and when can generic versions of Lamictal launch?

Lamictal is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. 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-six suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-003May 29, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-001May 29, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-004May 29, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-002May 29, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-005Dec 27, 1994ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-002May 8, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-004May 8, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL CDlamotrigineTABLET, CHEWABLE;ORAL020764-004Sep 8, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-006Jun 21, 2011ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-002Dec 27, 1994ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: LAMICTAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-005Dec 27, 1994► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-004Dec 27, 1994► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-002Dec 27, 1994► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-003Dec 27, 1994► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-001Dec 27, 1994► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTALlamotrigineTABLET;ORAL020241-006Dec 27, 1994► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Covington
Chubb
Cerilliant
Julphar
Merck
QuintilesIMS
Johnson and Johnson
McKesson

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