Xopenex is a drug owned by Hikma Pharmaceuticals Usa Inc. It is protected by 3 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 Mar 21, 2021. Details of Xopenex'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). | |||
| US6451289 | Albuterol formulations |
Mar, 2021
(4 years ago) |
Expired
|
| US5547994 | Method for treating asthma using optically pure R(-) albuterol |
Aug, 2013
(12 years ago) |
Expired
|
| US5362755 | Method for treating asthma using optically pure (R)-albuterol |
Mar, 2013
(12 years 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 Xopenex's patents.
Latest Legal Activities on Xopenex's Patents
Given below is the list of recent legal activities going on the following patents of Xopenex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change
Critical | 28 Feb, 2005 | US6451289 |
| Correspondence Address Change
Critical | 06 Dec, 2004 | US6451289 |
| Post Issue Communication - Certificate of Correction | 24 Jul, 2003 | US6451289 |
| Post Issue Communication - Certificate of Correction Denied | 25 Feb, 2003 | US6451289 |
| Post Issue Communication - Certificate of Correction Denied | 19 Dec, 2002 | US6451289 |
| Recordation of Patent Grant Mailed
Critical | 17 Sep, 2002 | US6451289 |
| Patent Issue Date Used in PTA Calculation
Critical | 17 Sep, 2002 | US6451289 |
| Issue Notification Mailed
Critical | 29 Aug, 2002 | US6451289 |
| Application Is Considered Ready for Issue
Critical | 16 Aug, 2002 | US6451289 |
| Workflow - Drawings Finished | 05 Aug, 2002 | US6451289 |
FDA has granted several exclusivities to Xopenex. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Xopenex, 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
Xopenex.
Exclusivity Information
Xopenex holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Xopenex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-151) | Jan 22, 2018 |
US patents provide insights into the exclusivity only within the United States, but
Xopenex 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 Xopenex's family patents as well as insights into
ongoing legal events
on those patents.
Xopenex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xopenex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 21, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xopenex Generic API suppliers:
Levalbuterol Hydrochloride is the generic name for the brand Xopenex. 10 different companies have already filed for the generic of Xopenex, with Luoxin Aurovitas having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xopenex's generic
How can I launch a generic of Xopenex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xopenex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xopenex'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 Xopenex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0103%, 0.021% and 0.042% | 20 Jun, 2005 | 1 | 09 Apr, 2008 | 21 Mar, 2021 | Eligible |
| 0.0025 | 23 May, 2006 | 1 | 20 Mar, 2009 | 21 Mar, 2021 | Eligible |
About Xopenex
Xopenex is a drug owned by Hikma Pharmaceuticals Usa Inc. It is used for treating or preventing bronchospasm. Xopenex uses Levalbuterol Hydrochloride as an active ingredient. Xopenex was launched by Hikma in 2002.
Approval Date:
Xopenex was approved by FDA for market use on 30 January, 2002.
Active Ingredient:
Xopenex uses Levalbuterol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Levalbuterol Hydrochloride ingredient
Treatment:
Xopenex is used for treating or preventing bronchospasm.
Dosage:
Xopenex is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INHALATION |
| EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INHALATION |
| EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INHALATION |
| EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INHALATION |