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Last Updated: May 28, 2022

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, Anchen Pharms, Atlantide, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Yiling, Zydus Pharms, Alembic Pharms Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Cipla, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-three 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. Fifty 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
Brown UniversityPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Postgraduate Institute of Dental Sciences RohtakPhase 4

See all lamotrigine clinical trials

Generic filers with tentative approvals for LAMOTRIGINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing200MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing150MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET;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
Sandoz LAMOTRIGINE lamotrigine TABLET, FOR SUSPENSION;ORAL 078409-002 Jan 22, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz LAMOTRIGINE lamotrigine TABLET;ORAL 078645-003 Jan 27, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Roxane LAMOTRIGINE lamotrigine TABLET;ORAL 077392-004 Jan 27, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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, FOR SUSPENSION;ORAL 020764-003 Aug 24, 1998 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-001 Aug 24, 1998 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-004 Sep 8, 2000 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-002 Aug 24, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lamotrigine

Country Patent Number Title Estimated Expiration
Brazil PI0307319 forma de dosagem oral para liberação controlada de droga e processo para sua preparação See Plans and Pricing
Eurasian Patent Organization 008286 ПЕРОРАЛЬНАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА (ORAL DOSAGE FORM FOR CONTROLLED DRUG RELEASE) See Plans and Pricing
Germany 60331041 See Plans and Pricing
Japan 2013241462 ORALLY DISINTEGRATING TABLET COMPOSITION OF LAMOTRIGINE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Moodys
AstraZeneca
Baxter
Express Scripts

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.