You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Lamotrigine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, 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, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, 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 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-one suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for lamotrigine

See drug prices for lamotrigine

Drug Sales Revenue Trends for lamotrigine

See drug sales revenues for lamotrigine

Recent Clinical Trials for lamotrigine

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

SponsorPhase
Westfälische Wilhelms-Universität MünsterPhase 4
Dr. Inge WinterPhase 4
Dr Cipto Mangunkusumo General HospitalPhase 4

See all lamotrigine clinical trials

Generic filers with tentative approvals for LAMOTRIGINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial150MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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 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
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-004 Sep 8, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 213271-002 Jan 19, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zennova LAMOTRIGINE lamotrigine TABLET;ORAL 078310-002 Feb 4, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-006 Dec 27, 1994 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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, FOR SUSPENSION;ORAL 020764-004 Sep 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-001 May 29, 2009 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-004 Dec 27, 1994 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-003 Dec 27, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lamotrigine

Country Patent Number Title Estimated Expiration
Poland 374982 Preparaty o przedłużonym uwalnianiu zawierające lamotriginę (SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE) ⤷  Try a Trial
Japan 2005538113 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004012741 ⤷  Try a Trial
China 101229169 Sustained release formulations comprising lamotrigine ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.