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Lamotrigine - Generic Drug Details

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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, Matrix Labs Ltd, Torrent Pharms, Par Pharm, Actavis Totowa, Glenmark Generics, Torrent Pharms Ltd, Unichem Labs Ltd, Anchen Pharms, Sciegen Pharms Inc, Wockhardt, Cipla Ltd, Wilshire Pharms Inc, Lupin Ltd, Roxane, Alkem Labs Ltd, and Wockhardt Ltd, and is included in forty-nine NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and two patent family members in thirty-eight countries.

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

Summary for Generic Name: lamotrigine

Tradenames:5
Patents:5
Applicants:35
NDAs:49
Drug Master File Entries: see list32
Suppliers / Packaging: see list64
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for LAMOTRIGINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL25MG
<disabled><disabled>TABLET; ORAL100MG
<disabled><disabled>TABLET; ORAL150MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms Ltd
LAMOTRIGINE
lamotrigine
TABLET, EXTENDED RELEASE;ORAL203370-004Dec 23, 2013RXNo► subscribe► subscribe
Watson Labs
LAMOTRIGINE
lamotrigine
TABLET, CHEWABLE;ORAL076928-001Jan 22, 2009RXNo► subscribe► subscribe
Torrent Pharms
LAMOTRIGINE
lamotrigine
TABLET;ORAL078947-004Jan 27, 2009RXNo► 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;ORAL020764-003Aug 24, 19984,602,017*PED► subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-001Dec 27, 19944,602,017*PED► subscribe
Glaxosmithkline Llc
LAMICTAL
lamotrigine
TABLET;ORAL020241-005Dec 27, 19944,602,017*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
China100363007► subscribe
Morocco27689► subscribe
South Africa200405722► 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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