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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7919115 | Orally disintegrating tablet compositions of lamotrigine |
Jan, 2029
(4 years from now) | Active |
| US8840925 | Orally disintegrating tablet compositions of lamotrigine |
Jul, 2028
(3 years from now) | Active |
| US9339504 | Orally disintegrating tablet compositions of lamotrigine |
Jul, 2028
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Lamictal Odt's patents.
Latest Legal Activities on Lamictal Odt's Patents
Given below is the list of recent legal activities going on the following patents of Lamictal Odt.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 08 May, 2023 | US7919115 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 21 Nov, 2022 | US7919115 (Litigated) |
| Email Notification Critical | 27 Apr, 2022 | US7919115 (Litigated) |
| Mail PUB other miscellaneous communication to applicant | 25 Apr, 2022 | US7919115 (Litigated) |
| PUB Other miscellaneous communication to applicant | 21 Apr, 2022 | US7919115 (Litigated) |
| Letter of Express Abandonment Filed | 18 Apr, 2022 | US7919115 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Oct, 2018 | US7919115 (Litigated) |
| Post Issue Communication - Certificate of Correction | 01 Feb, 2013 | US7919115 (Litigated) |
| Post Issue Communication - Certificate of Correction | 12 May, 2011 | US7919115 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 05 Apr, 2011 | US7919115 (Litigated) |
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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Lamictal Odt
Lamictal Odt which 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., has several other brand drugs using the same active ingredient (Lamotrigine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Glaxosmithkline Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Lamotrigine, Lamictal Odt's active ingredient. Check the complete list of approved generic manufacturers for Lamictal Odt
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.
Approval 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 |
|---|---|---|---|
| 25MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |
| 100MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |
| 200MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |
| 50MG | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |