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Last Updated: April 17, 2021

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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 freedom to operate?

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, Atlantide, Par Pharm, Rubicon, Torrent, 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-seven 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Université de SherbrookePhase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Brown UniversityPhase 2

See all lamotrigine clinical trials

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
Hikma Pharms LAMOTRIGINE lamotrigine TABLET;ORAL 078134-004 Apr 19, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Atlantide LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202498-003 Jan 4, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202383-001 Jun 19, 2013 AB RX No 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 020764-001 Aug 24, 1998   Start Trial   Start Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-001 Dec 27, 1994   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:

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