Avelox In Sodium Chloride 0.8% In Plastic Container is a drug owned by Bayer Healthcare Pharmaceuticals 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 Jul 25, 2020. Details of Avelox In Sodium Chloride 0.8% In Plastic Container'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). | |||
| US6548079 | Moxifloxacin formulation containing common salt |
Jul, 2020
(4 years ago) |
Expired
|
| US5849752 | Crystal modification of CDCH a process for its preparation and pharmaceutical formulations comprising this modification |
Dec, 2016
(8 years ago) |
Expired
|
| US5607942 | 7-(1-pyrrolidinyl)-3-quinolone- and - naphthyridone-carboxylic acid derivatives as antibacterial agents and feed additives |
Mar, 2014
(10 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 Avelox In Sodium Chloride 0.8% In Plastic Container's patents.
Latest Legal Activities on Avelox In Sodium Chloride 0.8% In Plastic Container's Patents
Given below is the list of recent legal activities going on the following patents of Avelox In Sodium Chloride 0.8% In Plastic Container.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 15 Apr, 2003 | US6548079 |
| Recordation of Patent Grant Mailed Critical | 15 Apr, 2003 | US6548079 |
| Adjustment of PTA Calculation by PTO | 27 Mar, 2003 | US6548079 |
| Issue Notification Mailed Critical | 26 Mar, 2003 | US6548079 |
| Receipt into Pubs | 14 Mar, 2003 | US6548079 |
| Application Is Considered Ready for Issue Critical | 12 Mar, 2003 | US6548079 |
| Issue Fee Payment Received Critical | 26 Feb, 2003 | US6548079 |
| Issue Fee Payment Verified Critical | 26 Feb, 2003 | US6548079 |
| Receipt into Pubs | 04 Feb, 2003 | US6548079 |
| Receipt into Pubs | 26 Dec, 2002 | US6548079 |
FDA has granted several exclusivities to Avelox In Sodium Chloride 0.8% In Plastic Container. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Avelox In Sodium Chloride 0.8% In Plastic Container, 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 Avelox In Sodium Chloride 0.8% In Plastic Container.
Exclusivity Information
Avelox In Sodium Chloride 0.8% In Plastic Container holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Avelox In Sodium Chloride 0.8% In Plastic Container's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-185) | Sep 27, 2019 |
US patents provide insights into the exclusivity only within the United States, but Avelox In Sodium Chloride 0.8% In Plastic Container 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 Avelox In Sodium Chloride 0.8% In Plastic Container's family patents as well as insights into ongoing legal events on those patents.
Avelox In Sodium Chloride 0.8% In Plastic Container's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avelox In Sodium Chloride 0.8% In Plastic Container's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 25, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avelox In Sodium Chloride 0.8% In Plastic Container Generic API suppliers:
Moxifloxacin Hydrochloride is the generic name for the brand Avelox In Sodium Chloride 0.8% In Plastic Container. 20 different companies have already filed for the generic of Avelox In Sodium Chloride 0.8% In Plastic Container, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Avelox In Sodium Chloride 0.8% In Plastic Container's generic
How can I launch a generic of Avelox In Sodium Chloride 0.8% In Plastic Container before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avelox In Sodium Chloride 0.8% In Plastic Container's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avelox In Sodium Chloride 0.8% In Plastic Container'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 Avelox In Sodium Chloride 0.8% In Plastic Container -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.6 mg/mL | 07 Feb, 2014 | 1 | 05 May, 2017 | 25 Jul, 2020 | Deferred |
Alternative Brands for Avelox In Sodium Chloride 0.8% In Plastic Container
Avelox In Sodium Chloride 0.8% In Plastic Container which is used for treating bacterial infections in patients., has several other brand drugs in the same treatment category and using the same active ingredient (Moxifloxacin Hydrochloride). 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 | Treatment Area | ||
|---|---|---|---|---|
| Bayer Hlthcare |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Moxifloxacin Hydrochloride. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Moxifloxacin Hydrochloride, Avelox In Sodium Chloride 0.8% In Plastic Container's active ingredient. Check the complete list of approved generic manufacturers for Avelox In Sodium Chloride 0.8% In Plastic Container
About Avelox In Sodium Chloride 0.8% In Plastic Container
Avelox In Sodium Chloride 0.8% In Plastic Container is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating bacterial infections in patients. Avelox In Sodium Chloride 0.8% In Plastic Container uses Moxifloxacin Hydrochloride as an active ingredient. Avelox In Sodium Chloride 0.8% In Plastic Container was launched by Bayer Hlthcare in 2001.
Approval Date:
Avelox In Sodium Chloride 0.8% In Plastic Container was approved by FDA for market use on 30 November, 2001.
Active Ingredient:
Avelox In Sodium Chloride 0.8% In Plastic Container uses Moxifloxacin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Moxifloxacin Hydrochloride ingredient
Treatment:
Avelox In Sodium Chloride 0.8% In Plastic Container is used for treating bacterial infections in patients.
Dosage:
Avelox In Sodium Chloride 0.8% In Plastic Container is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INTRAVENOUS |