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Serving leading biopharmaceutical companies globally:

Fuji
Daiichi Sankyo
Mallinckrodt
QuintilesIMS
Teva
Harvard Business School
Fish and Richardson
Covington
Cipla
McKinsey

Generated: December 16, 2017

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LAMICTAL XR Drug Profile

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

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

This drug has ninety-three patent family members in thirty-eight countries.

The generic ingredient in LAMICTAL XR 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 Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-001May 29, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-004May 29, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-002May 29, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-005Apr 14, 2010ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-004May 29, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-001May 29, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-002May 29, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-003May 29, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-003May 29, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcLAMICTAL XRlamotrigineTABLET, EXTENDED RELEASE;ORAL022115-006Jun 21, 2011ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for LAMICTAL XR

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

International Patent Family for Tradename: LAMICTAL XR

Country Document Number Estimated Expiration
European Patent Office1524981► Subscribe
Denmark1524981► Subscribe
Malaysia139719► Subscribe
Germany60326590► Subscribe
Argentina040709► Subscribe
Japan4744142► Subscribe
Cyprus1109119► Subscribe
Israel163098► Subscribe
Canada2475544► Subscribe
Chile2007003010► 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:

Moodys
Boehringer Ingelheim
QuintilesIMS
AstraZeneca
Covington
Queensland Health
US Army
Accenture
Cipla
Fish and Richardson

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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