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Generated: December 15, 2017

DrugPatentWatch Database Preview

LAMICTAL ODT Drug Profile

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Which patents cover Lamictal Odt, and what generic alternatives are available?

Lamictal Odt is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventeen patent family members in twelve countries.

The generic ingredient in LAMICTAL ODT 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 ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-001May 8, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-002May 8, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-001May 8, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-003May 8, 2009ABRXYesNo► 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► Subscribe► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-004May 8, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-001May 8, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-001May 8, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL ODTlamotrigineTABLET, ORALLY DISINTEGRATING;ORAL022251-002May 8, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for LAMICTAL ODT

Drugname Dosage Strength RLD Submissiondate
lamotrigineOrally Disintegrating Tablets25 mg, 50 mg, 100 mg, and 200 mgLamictal ODT12/21/2009

Non-Orange Book Patents for Tradename: LAMICTAL ODT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,647,656Orally disintegrating tablet compositions of lamotrigine► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LAMICTAL ODT

Country Document Number Estimated Expiration
Hong Kong1201745► Subscribe
Japan2013241462► Subscribe
Argentina068185► Subscribe
Taiwan200911267► Subscribe
Japan5346021► Subscribe
European Patent Office2173172► Subscribe
TaiwanI547282► Subscribe
Japan2010532384► Subscribe
New Zealand582458► Subscribe
World Intellectual Property Organization (WIPO)2009006516► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Teva
UBS
Julphar
Merck
Cerilliant
Cipla
Chinese Patent Office
Novartis
Covington
Cantor Fitzgerald

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 verifification 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.

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