Jenloga is a drug owned by Concordia Pharmaceuticals Inc. 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 Oct 13, 2013. Details of Jenloga'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). | |||
| US5869100 | Extended release clonidine formulation (tablet) |
Oct, 2013
(11 years ago) |
Expired
|
FDA has granted several exclusivities to Jenloga. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jenloga, 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 Jenloga.
Exclusivity Information
Jenloga holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Jenloga's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 29, 2012 |
US patents provide insights into the exclusivity only within the United States, but Jenloga 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 Jenloga's family patents as well as insights into ongoing legal events on those patents.
Jenloga's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Jenloga's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 13, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jenloga Generic API suppliers:
Clonidine Hydrochloride is the generic name for the brand Jenloga. 35 different companies have already filed for the generic of Jenloga, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jenloga's generic
How can I launch a generic of Jenloga before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jenloga's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jenloga'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 Jenloga -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 mg and 0.2 mg | 04 Mar, 2011 | 1 | 02 Apr, 2014 | 13 Oct, 2013 | Extinguished |
| 0.1 mg and 0.2 mg | 04 Mar, 2011 | 1 | 30 Sep, 2013 | 13 Oct, 2013 | Eligible |
Alternative Brands for Jenloga
There are several other brand drugs using the same active ingredient (Clonidine Hydrochloride) as Jenloga. 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clonidine Hydrochloride, Jenloga's active ingredient. Check the complete list of approved generic manufacturers for Jenloga
About Jenloga
Jenloga is a drug owned by Concordia Pharmaceuticals Inc. Jenloga uses Clonidine Hydrochloride as an active ingredient. Jenloga was launched by Concordia Pharms Inc in 2009.
Approval Date:
Jenloga was approved by FDA for market use on 30 September, 2009.
Active Ingredient:
Jenloga uses Clonidine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Clonidine Hydrochloride ingredient
Dosage:
Jenloga is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |