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Last Updated: November 21, 2024

LAMICTAL ODT Drug Patent Profile


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When do Lamictal Odt patents expire, and when can generic versions of Lamictal Odt launch?

Lamictal Odt is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lamictal Odt

A generic version of LAMICTAL ODT was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.

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Drug patent expirations by year for LAMICTAL ODT
Drug Prices for LAMICTAL ODT

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Drug Sales Revenue Trends for LAMICTAL ODT

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Recent Clinical Trials for LAMICTAL ODT

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

SponsorPhase
Dr Cipto Mangunkusumo General HospitalPhase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Brown UniversityPhase 2

See all LAMICTAL ODT clinical trials

Paragraph IV (Patent) Challenges for LAMICTAL ODT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 LAMICTAL ODT

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 ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-002 May 8, 2009 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-003 May 8, 2009 AB RX Yes 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

International Patents for LAMICTAL ODT

See the table below for patents covering LAMICTAL ODT around the world.

Country Patent Number Title Estimated Expiration
China 104161733 Orally disintegrating tablet compositions of lamotrigine ⤷  Sign Up
China 101801192 Orally disintegrating tablet compositions of lamotrigine ⤷  Sign Up
Australia 2008272871 Orally disintegrating tablet compositions of lamotrigine ⤷  Sign Up
Saudi Arabia 08290401 تركيبات أقراص لاموتريجين تتفتت بالفم (Orally Disintegrating Tablet Compositions of Lamotrigine) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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