Lamictal Cd is a drug owned by Glaxosmithkline Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 18, 2018. Details of Lamictal Cd'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). | |||
|
US5698226 (Pediatric) | Water-dispersible tablets |
Jul, 2012
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Lamictal Cd. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lamictal Cd, 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 Cd.
Exclusivity Information
Lamictal Cd holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Lamictal Cd'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 Cd 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 Cd's family patents as well as insights into ongoing legal events on those patents.
Lamictal Cd's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lamictal Cd's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 18, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lamictal Cd Generic API suppliers:
Lamotrigine is the generic name for the brand Lamictal Cd. 39 different companies have already filed for the generic of Lamictal Cd, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lamictal Cd's generic
How can I launch a generic of Lamictal Cd before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lamictal Cd's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lamictal Cd'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 Cd -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg, 5 mg and 25 mg |
Alternative Brands for Lamictal Cd
There are several other brand drugs using the same active ingredient (Lamotrigine) as Lamictal Cd. 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 Cd's active ingredient. Check the complete list of approved generic manufacturers for Lamictal Cd
About Lamictal Cd
Lamictal Cd is a drug owned by Glaxosmithkline Llc. Lamictal Cd uses Lamotrigine as an active ingredient. Lamictal Cd was launched by Glaxosmithkline Llc in 2000.
Approval Date:
Lamictal Cd was approved by FDA for market use on 08 September, 2000.
Active Ingredient:
Lamictal Cd uses Lamotrigine as the active ingredient. Check out other Drugs and Companies using Lamotrigine ingredient
Dosage:
Lamictal Cd is available in tablet, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET, FOR SUSPENSION | Prescription | ORAL |
| 25MG | TABLET, FOR SUSPENSION | Prescription | ORAL |
| 100MG | TABLET, FOR SUSPENSION | Discontinued | ORAL |
| 2MG | TABLET, FOR SUSPENSION | Prescription | ORAL |