Lamictal Odt Patent Expiration

Lamictal Odt is a drug owned by Glaxosmithkline Llc. It is protected by 3 US drug patents filed from 2013 to 2016 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 04, 2029. Details of Lamictal Odt's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9339504 Orally disintegrating tablet compositions of lamotrigine
Jul, 2028

(3 years from now)

Active
US8840925 Orally disintegrating tablet compositions of lamotrigine
Jul, 2028

(3 years from now)

Active
US7919115 Orally disintegrating tablet compositions of lamotrigine
Jan, 2029

(4 years from now)

Active


FDA has granted several exclusivities to Lamictal Odt. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lamictal Odt, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Lamictal Odt.

Exclusivity Information

Lamictal Odt holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Lamictal Odt's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-159) May 18, 2018

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US patents provide insights into the exclusivity only within the United States, but Lamictal Odt is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Lamictal Odt's family patents as well as insights into ongoing legal events on those patents.

Lamictal Odt's family patents

Lamictal Odt has patent protection in a total of 13 countries. It's US patent count contributes only to 31.8% of its total global patent coverage. 7 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Lamictal Odt.

Family Patents

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Generic Launch

Generic Release Date:

Lamictal Odt's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 04, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Lamictal Odt Generics:

Lamotrigine is the generic name for the brand Lamictal Odt. 39 different companies have already filed for the generic of Lamictal Odt, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lamictal Odt's generic

How can I launch a generic of Lamictal Odt before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Lamictal Odt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lamictal Odt's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Lamictal Odt -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
25 mg, 50 mg, 100 mg, and 200 mg 21 Dec, 2009 1 15 Jul, 2013 04 Jan, 2029 Deferred




About Lamictal Odt

Lamictal Odt is a drug owned by Glaxosmithkline Llc. It is used for treating epilepsy in patients greater than or equal to 2 years of age by providing adjunctive therapy for partial seizures and primary generalized tonic-clonic seizures. Lamictal Odt uses Lamotrigine as an active ingredient. Lamictal Odt was launched by Glaxosmithkline Llc in 2009.

Market Authorisation Date:

Lamictal Odt was approved by FDA for market use on 08 May, 2009.

Active Ingredient:

Lamictal Odt uses Lamotrigine as the active ingredient. Check out other Drugs and Companies using Lamotrigine ingredient

Treatment:

Lamictal Odt is used for treating epilepsy in patients greater than or equal to 2 years of age by providing adjunctive therapy for partial seizures and primary generalized tonic-clonic seizures.

Dosage:

Lamictal Odt is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
50MG TABLET, ORALLY DISINTEGRATING Prescription ORAL
100MG TABLET, ORALLY DISINTEGRATING Prescription ORAL
200MG TABLET, ORALLY DISINTEGRATING Prescription ORAL
25MG TABLET, ORALLY DISINTEGRATING Prescription ORAL