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Last Updated: November 2, 2024

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, Actavis Elizabeth, Amneal Pharms, Dr Reddys Labs Ltd, Endo Operations, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Natco Pharma, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamotrigine has forty-four patent family members in thirty countries.

There are thirty-two drug master file entries for lamotrigine. Fifty-three 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
Mental Health Services in the Capital Region, DenmarkPhase 4
Westfälische Wilhelms-Universität MünsterPhase 4
Dr. Inge WinterPhase 4

See all lamotrigine clinical trials

Generic filers with tentative approvals for LAMOTRIGINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up200MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up150MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up100MGTABLET;ORAL

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

Anatomical Therapeutic Chemical (ATC) Classes for lamotrigine
Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LAMICTAL XR Extended-release Tablets lamotrigine 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg 022115 1 2014-02-12
LAMICTAL ODT Orally Disintegrating Tablets lamotrigine 25 mg, 50 mg, 100 mg, and 200 mg 022251 1 2009-12-21

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
Rubicon LAMOTRIGINE lamotrigine TABLET;ORAL 078625-001 Jan 27, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro Pharm Inds LAMOTRIGINE lamotrigine TABLET;ORAL 078525-002 Jan 27, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unichem Labs Ltd LAMOTRIGINE lamotrigine TABLET;ORAL 090170-002 Oct 6, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising LAMOTRIGINE lamotrigine TABLET;ORAL 077420-003 Jan 27, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic Pharms Ltd LAMOTRIGINE lamotrigine TABLET;ORAL 090607-001 Jan 13, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-002 Aug 24, 1998 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-001 May 29, 2009 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-002 Dec 27, 1994 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-005 Dec 27, 1994 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >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 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.