Zymaxid is a drug owned by Abbvie Inc. It is protected by 4 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 Feb 20, 2020. Details of Zymaxid'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). | |||
|
US6333045 (Pediatric) | Aqueous liquid pharmaceutical composition comprised of gatifloxacin |
Feb, 2020
(4 years ago) |
Expired
|
| US6333045 | Aqueous liquid pharmaceutical composition comprised of gatifloxacin |
Aug, 2019
(5 years ago) |
Expired
|
|
US5880283 (Pediatric) | 8-alkoxyquinolonecarboxylic acid hydrate with excellent stability and process for producing the same |
Jun, 2016
(8 years ago) |
Expired
|
| US5880283 | 8-alkoxyquinolonecarboxylic acid hydrate with excellent stability and process for producing the same |
Dec, 2015
(8 years ago) |
Expired
|
FDA has granted several exclusivities to Zymaxid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zymaxid, 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 Zymaxid.
Exclusivity Information
Zymaxid holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Zymaxid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 18, 2013 |
US patents provide insights into the exclusivity only within the United States, but Zymaxid 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 Zymaxid's family patents as well as insights into ongoing legal events on those patents.
Zymaxid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zymaxid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 20, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zymaxid Generic API suppliers:
Gatifloxacin is the generic name for the brand Zymaxid. 6 different companies have already filed for the generic of Zymaxid, with Apotex Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zymaxid's generic
How can I launch a generic of Zymaxid before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zymaxid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zymaxid'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 Zymaxid -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005 | 07 Dec, 2010 | 1 | 28 Aug, 2013 | 20 Aug, 2019 | Eligible |
Alternative Brands for Zymaxid
There are several other brand drugs using the same active ingredient (Gatifloxacin) as Zymaxid. 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 | |
|---|---|---|
| Allergan |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Gatifloxacin, Zymaxid's active ingredient. Check the complete list of approved generic manufacturers for Zymaxid
About Zymaxid
Zymaxid is a drug owned by Abbvie Inc. Zymaxid uses Gatifloxacin as an active ingredient. Zymaxid was launched by Abbvie in 2010.
Approval Date:
Zymaxid was approved by FDA for market use on 18 May, 2010.
Active Ingredient:
Zymaxid uses Gatifloxacin as the active ingredient. Check out other Drugs and Companies using Gatifloxacin ingredient
Dosage:
Zymaxid is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5% | SOLUTION/DROPS | Prescription | OPHTHALMIC |