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Generated: May 27, 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?

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, and Wockhardt 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 three patent family members in thirty-eight countries.

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

Summary for Generic Name: lamotrigine

Drug Master File Entries: see list32
Suppliers / Packagers: see list67
Bulk Api Vendors: see list75
Clinical Trials: see list45
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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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc
TABLET, EXTENDED RELEASE;ORAL022115-001May 29, 2009ABRXYesNo8,637,512► SubscribeY ► Subscribe
TABLET;ORAL078982-002Jan 27, 2009DISCNNoNo► Subscribe► Subscribe
Zydus Pharms Usa
TABLET;ORAL077633-001Jan 27, 2009ABRXNoNo► Subscribe► Subscribe
Glaxosmithkline Llc
TABLET, EXTENDED RELEASE;ORAL022115-005Apr 14, 2010ABRXYesNo9,144,547► SubscribeY ► Subscribe
Sciegen Pharms Inc
TABLET, ORALLY DISINTEGRATING;ORAL206382-004Jun 17, 2016ABRXNoNo► Subscribe► Subscribe
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  • Predict branded drug patent expiration
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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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