Fazaclo Odt is a drug owned by Jazz Pharmaceuticals Ireland Ltd. 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 Apr 09, 2018. Details of Fazaclo Odt'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). | |||
| US6024981 | Rapidly dissolving robust dosage form |
Apr, 2018
(6 years ago) |
Expired
|
| US6221392 | Rapidly dissolving robust dosage form |
Apr, 2018
(6 years ago) |
Expired
|
| US6106861 | Multiparticulate tablet disintegrating in less than 40 seconds in the mouth |
Dec, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Fazaclo Odt 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 Fazaclo Odt's family patents as well as insights into ongoing legal events on those patents.
Fazaclo Odt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fazaclo Odt's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 09, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fazaclo Odt Generic API suppliers:
Clozapine is the generic name for the brand Fazaclo Odt. 11 different companies have already filed for the generic of Fazaclo Odt, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fazaclo Odt's generic
How can I launch a generic of Fazaclo Odt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fazaclo Odt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fazaclo Odt'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 Fazaclo Odt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12.5 mg | 05 Jun, 2008 | 1 | 09 Apr, 2018 | Extinguished | |
| 25 mg and 100 mg | 28 Apr, 2008 | 1 | 25 Nov, 2015 | 09 Apr, 2018 | Extinguished |
| 150 mg | 08 Apr, 2011 | 1 | 25 Nov, 2015 | 09 Apr, 2018 | Deferred |
| 200 mg | 18 Apr, 2011 | 1 | 25 Nov, 2015 | 09 Apr, 2018 | Deferred |
Alternative Brands for Fazaclo Odt
There are several other brand drugs using the same active ingredient (Clozapine) as Fazaclo Odt. 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 | |
|---|---|---|
| Tasman Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clozapine, Fazaclo Odt's active ingredient. Check the complete list of approved generic manufacturers for Fazaclo Odt
About Fazaclo Odt
Fazaclo Odt is a drug owned by Jazz Pharmaceuticals Ireland Ltd. Fazaclo Odt uses Clozapine as an active ingredient. Fazaclo Odt was launched by Jazz in 2007.
Approval Date:
Fazaclo Odt was approved by FDA for market use on 30 May, 2007.
Active Ingredient:
Fazaclo Odt uses Clozapine as the active ingredient. Check out other Drugs and Companies using Clozapine ingredient
Dosage:
Fazaclo Odt is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |