Kapvay 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 Nov 20, 2017. Details of Kapvay'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 Kapvay. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kapvay, 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 Kapvay.
Exclusivity Information
Kapvay holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Kapvay's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 28, 2013 |
| M(M-149) | Nov 20, 2017 |
US patents provide insights into the exclusivity only within the United States, but Kapvay 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 Kapvay's family patents as well as insights into ongoing legal events on those patents.
Kapvay's Family Patents
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Generic Launch
Generic Release Date:
Kapvay's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 20, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kapvay Generic API suppliers:
Clonidine Hydrochloride is the generic name for the brand Kapvay. 35 different companies have already filed for the generic of Kapvay, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kapvay's generic
How can I launch a generic of Kapvay before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kapvay's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kapvay'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 Kapvay -
| 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 Kapvay
There are several other brand drugs using the same active ingredient (Clonidine Hydrochloride) as Kapvay. 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, Kapvay's active ingredient. Check the complete list of approved generic manufacturers for Kapvay
About Kapvay
Kapvay is a drug owned by Concordia Pharmaceuticals Inc. Kapvay uses Clonidine Hydrochloride as an active ingredient. Kapvay was launched by Concordia Pharms Inc in 2009.
Approval Date:
Kapvay was approved by FDA for market use on 30 September, 2009.
Active Ingredient:
Kapvay uses Clonidine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Clonidine Hydrochloride ingredient
Dosage:
Kapvay 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 | 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 |