Accuneb 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 Accuneb'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). | |||
| US6702997 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
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 Accuneb's patents.
Latest Legal Activities on Accuneb's Patents
Given below is the list of recent legal activities going on the following patents of Accuneb.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 03 Jul, 2019 | US6702997 |
| File Marked Found | 02 Oct, 2018 | US6702997 |
| Correspondence Address Change Critical | 13 Jun, 2014 | US6702997 |
| Correspondence Address Change Critical | 06 May, 2004 | US6702997 |
| Change in Power of Attorney (May Include Associate POA) Critical | 06 May, 2004 | US6702997 |
| Post Issue Communication - Certificate of Correction | 26 Mar, 2004 | US6702997 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Mar, 2004 | US6702997 |
| Recordation of Patent Grant Mailed Critical | 09 Mar, 2004 | US6702997 |
| Issue Notification Mailed Critical | 19 Feb, 2004 | US6702997 |
| Receipt into Pubs | 30 Jan, 2004 | US6702997 |
US patents provide insights into the exclusivity only within the United States, but Accuneb 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 Accuneb's family patents as well as insights into ongoing legal events on those patents.
Accuneb's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Accuneb'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)
Accuneb Generic API suppliers:
Albuterol Sulfate is the generic name for the brand Accuneb. 46 different companies have already filed for the generic of Accuneb, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Accuneb's generic
How can I launch a generic of Accuneb before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Accuneb's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Accuneb'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 Accuneb -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.00021 | 19 Oct, 2005 | 1 | 25 Sep, 2007 | 28 Dec, 2021 | Eligible |
| 0.00042 | 06 Apr, 2004 | 1 | 28 Jun, 2004 | 28 Dec, 2021 | Eligible |
Alternative Brands for Accuneb
Accuneb which is used for treating bronchospasm in children with asthma., has several other brand drugs using the same active ingredient (Albuterol Sulfate). 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 | |||
|---|---|---|---|---|
| Astrazeneca |
| |||
| Boehringer Ingelheim |
| |||
| Glaxosmithkline |
| |||
| Kindeva |
| |||
| Norvium Bioscience |
| |||
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Albuterol Sulfate, Accuneb's active ingredient. Check the complete list of approved generic manufacturers for Accuneb
About Accuneb
Accuneb is a drug owned by Norvium Bioscience Llc. It is used for treating bronchospasm in children with asthma. Accuneb uses Albuterol Sulfate as an active ingredient. Accuneb was launched by Norvium Bioscience in 2001.
Approval Date:
Accuneb was approved by FDA for market use on 30 April, 2001.
Active Ingredient:
Accuneb uses Albuterol Sulfate as the active ingredient. Check out other Drugs and Companies using Albuterol Sulfate ingredient
Treatment:
Accuneb is used for treating bronchospasm in children with asthma.
Dosage:
Accuneb is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INHALATION |
| EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INHALATION |