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LAMICTAL XR Drug Profile

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Which patents cover Lamictal Xr, and what substitute generic drugs 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 eighty-seven 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. There are two tentative approvals for this compound. Additional details are available on the lamotrigine profile page.

Summary for Tradename: LAMICTAL XR

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list75
Clinical Trials: see list8
Patent Applications: see list4,793
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LAMICTAL XR at DailyMed

Pharmacology for Tradename: LAMICTAL XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-001May 29, 2009RXYesNo8,637,512► SubscribeY ► Subscribe
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-004May 29, 2009RXYesYes8,637,512► SubscribeY ► Subscribe
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-002May 29, 2009RXYesYes9,144,547► SubscribeY ► Subscribe
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-005Apr 14, 2010RXYesNo8,637,512► SubscribeY ► Subscribe
Glaxosmithkline Llc
LAMICTAL XR
lamotrigine
TABLET, EXTENDED RELEASE;ORAL022115-004May 29, 2009RXYesYes9,144,547► SubscribeY ► Subscribe
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Paragraph IV activity 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
Japan4744142► Subscribe
China100363007► Subscribe
Argentina038417► Subscribe
Denmark1524981► Subscribe
South Korea100882707► 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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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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