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Last Updated: July 4, 2020

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Lamotrigine - Generic Drug Details

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

Lamotrigine is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Par Pharm, Rubicon, Torrent, Wockhardt Ltd, Zydus Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Celltrion, Cipla, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa, and is included in fifty-one NDAs. There are five 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 thirteen patent family members in thirty-eight countries.

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

Drug Prices for lamotrigine

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Drug Sales Revenue Trends for lamotrigine

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Recent Clinical Trials for lamotrigine

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SponsorPhase
Johns Hopkins UniversityPhase 3
Boehringer IngelheimN/A
Charite University, Berlin, GermanyN/A

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Generic filers with tentative approvals for LAMOTRIGINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL XR TABLET, EXTENDED RELEASE;ORAL lamotrigine 022115 2014-02-12
LAMICTAL ODT TABLET, ORALLY DISINTEGRATING;ORAL lamotrigine 022251 2009-12-21
LAMICTAL CD TABLET, CHEWABLE;ORAL lamotrigine 020764
LAMICTAL TABLET;ORAL lamotrigine 020241

US Patents and Regulatory Information for lamotrigine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 076928-001 Jan 22, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Totowa LAMOTRIGINE lamotrigine TABLET;ORAL 078669-004 Apr 8, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla LAMOTRIGINE lamotrigine TABLET;ORAL 077783-003 Nov 1, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-001 Aug 24, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lamotrigine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-002 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-002 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-004 Sep 8, 2000   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-003 Aug 24, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
AstraZeneca
Moodys
McKesson
Mallinckrodt

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 verification 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.