Avelox 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 Oct 29, 2019. Details of Avelox'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). | |||
| US6610327 | Pharmaceutical moxifloxacin preparation |
Oct, 2019
(5 years ago) |
Expired
|
| US5849752 | Crystal modification of CDCH a process for its preparation and pharmaceutical formulations comprising this modification |
Dec, 2016
(7 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's patents.
Latest Legal Activities on Avelox's Patents
Given below is the list of recent legal activities going on the following patents of Avelox.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 26 Aug, 2003 | US6610327 |
| Recordation of Patent Grant Mailed Critical | 26 Aug, 2003 | US6610327 |
| Issue Notification Mailed Critical | 07 Aug, 2003 | US6610327 |
| Receipt into Pubs | 14 Jul, 2003 | US6610327 |
| Application Is Considered Ready for Issue Critical | 09 Jul, 2003 | US6610327 |
| Correspondence Address Change Critical | 08 Jul, 2003 | US6610327 |
| Issue Fee Payment Verified Critical | 24 Jun, 2003 | US6610327 |
| Issue Fee Payment Received Critical | 24 Jun, 2003 | US6610327 |
| Receipt into Pubs | 09 Jun, 2003 | US6610327 |
| Receipt into Pubs | 16 Apr, 2003 | US6610327 |
FDA has granted several exclusivities to Avelox. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Avelox, 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.
Exclusivity Information
Avelox holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Avelox'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 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's family patents as well as insights into ongoing legal events on those patents.
Avelox's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avelox's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 29, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avelox Generic API suppliers:
Moxifloxacin Hydrochloride is the generic name for the brand Avelox. 20 different companies have already filed for the generic of Avelox, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Avelox's generic
How can I launch a generic of Avelox before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avelox's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avelox'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg |
Alternative Brands for Avelox
Avelox which is used for treating bacterial infections., 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's active ingredient. Check the complete list of approved generic manufacturers for Avelox
About Avelox
Avelox is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating bacterial infections. Avelox uses Moxifloxacin Hydrochloride as an active ingredient. Avelox was launched by Bayer Hlthcare in 1999.
Approval Date:
Avelox was approved by FDA for market use on 10 December, 1999.
Active Ingredient:
Avelox uses Moxifloxacin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Moxifloxacin Hydrochloride ingredient
Treatment:
Avelox is used for treating bacterial infections.
Dosage:
Avelox is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |