Lamictal Xr is a drug owned by Glaxosmithkline Llc. It is protected by 2 US drug patents filed from 2014 to 2015. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2028. Details of Lamictal Xr'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). | |||
| US8637512 | Formulations and method of treatment |
Jun, 2028
(3 years from now) | Active |
| US9144547 | Oral dosage form for controlled drug release |
Sep, 2023
(1 year, 2 months ago) |
Expired
|
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 Xr's patents.
Latest Legal Activities on Lamictal Xr's Patents
Given below is the list of recent legal activities going on the following patents of Lamictal Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2023 | US9144547 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Feb, 2019 | US9144547 |
| Patent Issue Date Used in PTA Calculation Critical | 29 Sep, 2015 | US9144547 |
| Recordation of Patent Grant Mailed Critical | 29 Sep, 2015 | US9144547 |
| Email Notification Critical | 10 Sep, 2015 | US9144547 |
| Issue Notification Mailed Critical | 09 Sep, 2015 | US9144547 |
| Dispatch to FDC | 20 Aug, 2015 | US9144547 |
| Application Is Considered Ready for Issue Critical | 20 Aug, 2015 | US9144547 |
| Issue Fee Payment Verified Critical | 19 Aug, 2015 | US9144547 |
| Issue Fee Payment Received Critical | 19 Aug, 2015 | US9144547 |
FDA has granted several exclusivities to Lamictal Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lamictal Xr, 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 Xr.
Exclusivity Information
Lamictal Xr holds 4 exclusivities. All of its exclusivities have expired in 2014. Details of Lamictal Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | May 29, 2012 |
| Pediatric Exclusivity(PED) | Nov 29, 2012 |
| New Indication(I-622) | Jan 29, 2013 |
| New Indication(I-644) | Apr 25, 2014 |
US patents provide insights into the exclusivity only within the United States, but Lamictal Xr 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 Xr's family patents as well as insights into ongoing legal events on those patents.
Lamictal Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lamictal Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 14, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lamictal Xr Generic API suppliers:
Lamotrigine is the generic name for the brand Lamictal Xr. 40 different companies have already filed for the generic of Lamictal Xr, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lamictal Xr's generic
How can I launch a generic of Lamictal Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lamictal Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lamictal Xr'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 Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | 12 Feb, 2014 | 1 | 14 Jun, 2028 | Extinguished |
Alternative Brands for Lamictal Xr
There are several other brand drugs using the same active ingredient (Lamotrigine) as Lamictal Xr. 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 Xr's active ingredient. Check the complete list of approved generic manufacturers for Lamictal Xr
About Lamictal Xr
Lamictal Xr is a drug owned by Glaxosmithkline Llc. Lamictal Xr uses Lamotrigine as an active ingredient. Lamictal Xr was launched by Glaxosmithkline Llc in 2009.
Approval Date:
Lamictal Xr was approved by FDA for market use on 29 May, 2009.
Active Ingredient:
Lamictal Xr uses Lamotrigine as the active ingredient. Check out other Drugs and Companies using Lamotrigine ingredient
Dosage:
Lamictal Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 300MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 200MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 250MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 100MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 25MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |