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Serving 500+ biopharmaceutical companies globally:

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Baxter
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Accenture
Cipla
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Generated: July 20, 2017

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Lamotrigine - Generic Drug Details

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What are the generic sources for lamotrigine and what is the scope of lamotrigine patent protection?

Lamotrigine
is the generic ingredient in five branded drugs marketed by Aurobindo Pharma, Dr Reddys Labs Ltd, Taro, Alembic Pharms Ltd, Sandoz, Zydus Pharms Usa Inc, Pharmascience Inc, Glaxosmithkline Llc, Jubilant Generics, Teva, Mylan, Apotex Inc, Taro Pharm Inds, Watson Labs, Impax Labs Inc, Jubilant Cadista, Actavis Elizabeth, Zydus Pharms Usa, Hikma Pharms, Mylan Labs Ltd, Torrent Pharms, Par Pharm, Actavis Totowa, Glenmark Generics, Torrent Pharms Ltd, Unichem Labs Ltd, Anchen Pharms, Sciegen Pharms Inc, Wockhardt, Cipla Ltd, Handa Pharms Llc, Lupin Ltd, Roxane, Alkem Labs Ltd, Wockhardt Ltd, and Glenmark Pharms Ltd, and is included in forty-nine NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamotrigine has one hundred and five patent family members in thirty-eight countries.

There are thirty-two drug master file entries for lamotrigine. Sixty-five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: lamotrigine

Tradenames:5
Patents:6
Applicants:36
NDAs:49
Drug Master File Entries: see list32
Suppliers / Packagers: see list65
Bulk Api Vendors: see list75
Clinical Trials: see list175
Patent Applications: see list6,097
Therapeutic Class:Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lamotrigine at DailyMed

Tentative approvals for LAMOTRIGINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe25MGTABLET;ORAL
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► Subscribe► Subscribe150MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
LAMOTRIGINE
lamotrigine
TABLET, EXTENDED RELEASE;ORAL202383-005Jun 19, 2013ABRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
LAMOTRIGINE
lamotrigine
TABLET, CHEWABLE;ORAL076701-002Jan 22, 2009ABRXNoNo► Subscribe► Subscribe
Taro Pharm Inds
LAMOTRIGINE
lamotrigine
TABLET;ORAL078525-002Jan 27, 2009ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma
LAMOTRIGINE
lamotrigine
TABLET;ORAL078956-003Jan 27, 2009ABRXNoNo► Subscribe► Subscribe
Impax Labs Inc
LAMOTRIGINE
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL200828-003Jul 15, 2013ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lamotrigine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-002Aug 24, 19985,698,226*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-003Dec 27, 19944,602,017*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-004Dec 27, 19944,602,017*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-005Dec 27, 19944,602,017*PED► Subscribe
Glaxosmithkline Llc
LAMICTAL CD
lamotrigine
TABLET, CHEWABLE;ORAL020764-004Sep 8, 20004,602,017*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lamotrigine

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 Ingredient: lamotrigine

Country Document Number Estimated Expiration
Canada2693072► Subscribe
Japan4744142► Subscribe
Hong Kong1072194► Subscribe
New Zealand537885► Subscribe
Morocco27689► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fuji
Novartis
Chinese Patent Office
Fish and Richardson
Farmers Insurance
US Department of Justice
UBS
QuintilesIMS
Cerilliant
AstraZeneca

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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