Duoneb Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Duoneb.

Activity Date Patent Number
Patent litigations
File Marked Found 17 Oct, 2018 US6632842
Correspondence Address Change 20 May, 2004 US6632842
Recordation of Patent Grant Mailed 14 Oct, 2003 US6632842
Patent Issue Date Used in PTA Calculation 14 Oct, 2003 US6632842
Issue Notification Mailed 25 Sep, 2003 US6632842
Receipt into Pubs 19 Sep, 2003 US6632842
Application Is Considered Ready for Issue 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

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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


Family Patents

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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 Generics:

Albuterol Sulfate; Ipratropium Bromide is the generic name for the brand Duoneb. 9 different companies have already filed for the generic of Duoneb, with Apotex 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
Combivent
Combivent Respimat


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