Duoneb is a drug owned by Norvium Bioscience Llc. 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 Dec 28, 2021. Details of Duoneb'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). | |||
| US6632842 | Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
Dec, 2021
(2 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 Duoneb's patents.
Latest Legal Activities on Duoneb's Patents
Given below is the list of recent legal activities going on the following patents of Duoneb.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 17 Oct, 2018 | US6632842 |
| Correspondence Address Change Critical | 20 May, 2004 | US6632842 |
| Recordation of Patent Grant Mailed Critical | 14 Oct, 2003 | US6632842 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Oct, 2003 | US6632842 |
| Issue Notification Mailed Critical | 25 Sep, 2003 | US6632842 |
| Receipt into Pubs | 19 Sep, 2003 | US6632842 |
| Application Is Considered Ready for Issue Critical | 16 Sep, 2003 | US6632842 |
| Receipt into Pubs | 10 Sep, 2003 | US6632842 |
| Receipt into Pubs | 03 Sep, 2003 | US6632842 |
| Receipt into Pubs | 11 Jul, 2003 | US6632842 |
US patents provide insights into the exclusivity only within the United States, but Duoneb 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 Duoneb's family patents as well as insights into ongoing legal events on those patents.
Duoneb's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Duoneb's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 28, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Duoneb Generic API suppliers:
Albuterol Sulfate; Ipratropium Bromide is the generic name for the brand Duoneb. 9 different companies have already filed for the generic of Duoneb, with Aiping Pharm Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Duoneb's generic
How can I launch a generic of Duoneb before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Duoneb's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Duoneb'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 Duoneb -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.083%/ 0.017% |
Alternative Brands for Duoneb
Duoneb which is used for managing bronchospasm associated with COPD in patients who need more than one bronchodilator., has several other brand drugs using the same active ingredient (Albuterol Sulfate; Ipratropium Bromide). 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.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Boehringer Ingelheim |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Albuterol Sulfate; Ipratropium Bromide, Duoneb's active ingredient. Check the complete list of approved generic manufacturers for Duoneb
About Duoneb
Duoneb is a drug owned by Norvium Bioscience Llc. It is used for managing bronchospasm associated with COPD in patients who need more than one bronchodilator. Duoneb uses Albuterol Sulfate; Ipratropium Bromide as an active ingredient. Duoneb was launched by Norvium Bioscience in 2001.
Approval Date:
Duoneb was approved by FDA for market use on 21 March, 2001.
Active Ingredient:
Duoneb uses Albuterol Sulfate; Ipratropium Bromide as the active ingredient. Check out other Drugs and Companies using Albuterol Sulfate; Ipratropium Bromide ingredient
Treatment:
Duoneb is used for managing bronchospasm associated with COPD in patients who need more than one bronchodilator.
Dosage:
Duoneb is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INHALATION |