Uroxatral is a drug owned by Concordia Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 22, 2018. Details of Uroxatral'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). | |||
|
US6149940 (Pediatric) | Tablet with controlled release of alfuzosine chlorhydrate |
Feb, 2018
(6 years ago) |
Expired
|
| US6149940 | Tablet with controlled release of alfuzosine chlorhydrate |
Aug, 2017
(7 years ago) |
Expired
|
FDA has granted several exclusivities to Uroxatral. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Uroxatral, 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 Uroxatral.
Exclusivity Information
Uroxatral holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Uroxatral's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-97) | Dec 15, 2013 |
| Pediatric Exclusivity(PED) | Jun 15, 2014 |
US patents provide insights into the exclusivity only within the United States, but Uroxatral 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 Uroxatral's family patents as well as insights into ongoing legal events on those patents.
Uroxatral's Family Patents
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Generic Launch
Generic Release Date:
Uroxatral's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 22, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Uroxatral Generic API suppliers:
Alfuzosin Hydrochloride is the generic name for the brand Uroxatral. 9 different companies have already filed for the generic of Uroxatral, with Apotex Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Uroxatral's generic
How can I launch a generic of Uroxatral before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Uroxatral's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Uroxatral'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 Uroxatral -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg | 12 Jun, 2007 | 9 | 18 Jul, 2011 | 22 Aug, 2017 | Eligible |
About Uroxatral
Uroxatral is a drug owned by Concordia Pharmaceuticals Inc. Uroxatral uses Alfuzosin Hydrochloride as an active ingredient. Uroxatral was launched by Concordia in 2003.
Approval Date:
Uroxatral was approved by FDA for market use on 12 June, 2003.
Active Ingredient:
Uroxatral uses Alfuzosin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Alfuzosin Hydrochloride ingredient
Dosage:
Uroxatral is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |