Xopenex Hfa is a drug owned by Lupin Inc. It is protected by 6 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 08, 2024. Details of Xopenex Hfa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7256310 | Levalbuterol salt |
Oct, 2024
(a month ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8765153 | Levalbuterol salt |
Dec, 2023
(11 months ago) |
Expired
|
| US5836299 | Seals for use in an aerosol delivery device |
Nov, 2015
(9 years ago) |
Expired
|
| US5605674 | Medicinal aerosol formulations |
Feb, 2014
(10 years ago) |
Expired
|
| US5547994 | Method for treating asthma using optically pure R(-) albuterol |
Aug, 2013
(11 years ago) |
Expired
|
| US5362755 | Method for treating asthma using optically pure (R)-albuterol |
Mar, 2013
(11 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 Hfa's patents.
Latest Legal Activities on Xopenex Hfa's Patents
Given below is the list of recent legal activities going on the following patents of Xopenex Hfa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2022 | US8765153 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2019 | US7256310 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Jan, 2018 | US8765153 |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US8765153 |
| Post Issue Communication - Certificate of Correction | 13 Aug, 2014 | US8765153 |
| Recordation of Patent Grant Mailed Critical | 01 Jul, 2014 | US8765153 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Jul, 2014 | US8765153 |
| Issue Notification Mailed Critical | 11 Jun, 2014 | US8765153 |
| Dispatch to FDC | 02 Jun, 2014 | US8765153 |
| Mail Response to 312 Amendment (PTO-271) Critical | 02 Jun, 2014 | US8765153 |
FDA has granted several exclusivities to Xopenex Hfa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xopenex Hfa, 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 Hfa.
Exclusivity Information
Xopenex Hfa holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Xopenex Hfa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-156) | Mar 12, 2018 |
Several oppositions have been filed on Xopenex Hfa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xopenex Hfa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xopenex Hfa patents.
Xopenex Hfa's Oppositions Filed in EPO
Xopenex Hfa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 16, 2011, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP06110646A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06110646A | Nov, 2011 | Teva Pharmaceutical Industries Ltd. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Xopenex Hfa 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 Hfa's family patents as well as insights into ongoing legal events on those patents.
Xopenex Hfa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xopenex Hfa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 08, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xopenex Hfa Generics:
There are no approved generic versions for Xopenex Hfa as of now.
How can I launch a generic of Xopenex Hfa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xopenex Hfa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xopenex Hfa'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 Hfa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.045 mg/actuation | 27 Feb, 2012 | 1 | 08 Oct, 2024 | Extinguished |
About Xopenex Hfa
Xopenex Hfa is a drug owned by Lupin Inc. It is used for managing asthma symptoms and bronchospasms. Xopenex Hfa uses Levalbuterol Tartrate as an active ingredient. Xopenex Hfa was launched by Lupin in 2005.
Approval Date:
Xopenex Hfa was approved by FDA for market use on 11 March, 2005.
Active Ingredient:
Xopenex Hfa uses Levalbuterol Tartrate as the active ingredient. Check out other Drugs and Companies using Levalbuterol Tartrate ingredient
Treatment:
Xopenex Hfa is used for managing asthma symptoms and bronchospasms.
Dosage:
Xopenex Hfa is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.045MG BASE/INH | AEROSOL, METERED | Prescription | INHALATION |