Moxeza is a drug owned by Harrow Eye Llc. It is protected by 8 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 29, 2029. Details of Moxeza'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). | |||
| US9114168 | Pharmaceutical compositions containing a fluoroquinolone antibiotic drug |
May, 2029
(4 years from now) | Active |
| US8450311 | Pharmaceutical compositions containing a fluoroquinolone antibiotic drug |
May, 2029
(4 years from now) | Active |
|
US7671070 (Pediatric) | Method of treating ophthalmic infections with moxifloxacin compositions |
Mar, 2020
(4 years ago) |
Expired
|
|
US6716830 (Pediatric) | Ophthalmic antibiotic compositions containing moxifloxacin |
Mar, 2020
(4 years ago) |
Expired
|
| US6716830 | Ophthalmic antibiotic compositions containing moxifloxacin |
Sep, 2019
(5 years ago) |
Expired
|
| US7671070 | Method of treating ophthalmic infections with moxifloxacin compositions |
Sep, 2019
(5 years ago) |
Expired
|
|
US5607942 (Pediatric) | 7-(1-pyrrolidinyl)-3-quinolone- and - naphthyridone-carboxylic acid derivatives as antibacterial agents and feed additives |
Sep, 2014
(10 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 Moxeza's patents.
Latest Legal Activities on Moxeza's Patents
Given below is the list of recent legal activities going on the following patents of Moxeza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 12 Apr, 2022 | US9114168 |
| Change in Power of Attorney (May Include Associate POA) Critical | 12 Apr, 2022 | US8450311 |
| Email Notification Critical | 12 Apr, 2022 | US9114168 |
| Email Notification Critical | 12 Apr, 2022 | US8450311 |
| Correspondence Address Change Critical | 08 Apr, 2022 | US8450311 |
| Correspondence Address Change Critical | 08 Apr, 2022 | US9114168 |
| Expire Patent Critical | 04 Apr, 2022 | US7671070 |
| Maintenance Fee Reminder Mailed Critical | 18 Oct, 2021 | US7671070 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Nov, 2020 | US8450311 |
| Expire Patent Critical | 30 Sep, 2019 | US9114168 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Moxeza and ongoing litigations to help you estimate the early arrival of Moxeza generic.
Moxeza's Litigations
Moxeza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 12, 2012, against patent number US7671070. The petitioner Apotex Inc., challenged the validity of this patent, with Alcon as the respondent. Click below to track the latest information on how companies are challenging Moxeza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6716830 | October, 2012 |
Terminated-Settled
(15 Nov, 2013) | Alcon Pharmaceuticals Ltd. | Apotex Inc. |
| US7671070 | October, 2012 |
Terminated-Settled
(15 Nov, 2013) | Alcon | Apotex Inc. |
FDA has granted some exclusivities to Moxeza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Moxeza, 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 Moxeza.
Exclusivity Information
Moxeza holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Moxeza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 19, 2013 |
| Pediatric Exclusivity(PED) | May 19, 2014 |
US patents provide insights into the exclusivity only within the United States, but Moxeza 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 Moxeza's family patents as well as insights into ongoing legal events on those patents.
Moxeza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Moxeza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 29, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Moxeza Generic API suppliers:
Moxifloxacin Hydrochloride is the generic name for the brand Moxeza. 21 different companies have already filed for the generic of Moxeza, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Moxeza's generic
How can I launch a generic of Moxeza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Moxeza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Moxeza'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 Moxeza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005 | 29 Feb, 2012 | 1 | 28 May, 2015 | 20 Sep, 2019 | Eligible |
Alternative Brands for Moxeza
Moxeza 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.
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.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Bayer Hlthcare |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Moxifloxacin Hydrochloride, Moxeza's active ingredient. Check the complete list of approved generic manufacturers for Moxeza
About Moxeza
Moxeza is a drug owned by Harrow Eye Llc. It is used for treating bacterial infections in patients. Moxeza uses Moxifloxacin Hydrochloride as an active ingredient. Moxeza was launched by Harrow Eye in 2010.
Approval Date:
Moxeza was approved by FDA for market use on 19 November, 2010.
Active Ingredient:
Moxeza uses Moxifloxacin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Moxifloxacin Hydrochloride ingredient
Treatment:
Moxeza is used for treating bacterial infections in patients.
Dosage:
Moxeza is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.5% BASE | SOLUTION/DROPS | Discontinued | OPHTHALMIC |