Ziana is a drug owned by Bausch Health Us Llc. It is protected by 2 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 Aug 03, 2020. Details of Ziana'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). | |||
| US6387383 | Topical low-viscosity gel composition |
Aug, 2020
(4 years ago) |
Expired
|
| USRE41134 | Slow release vehicles for minimizing skin irritancy of topical compositions |
Feb, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Ziana 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 Ziana's family patents as well as insights into ongoing legal events on those patents.
Ziana's Family Patents
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Generic Launch
Generic Release Date:
Ziana's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 03, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ziana Generic API suppliers:
Clindamycin Phosphate; Tretinoin is the generic name for the brand Ziana. 3 different companies have already filed for the generic of Ziana, with Actavis Mid Atlantic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ziana's generic
How can I launch a generic of Ziana before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ziana's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ziana'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 Ziana -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.2%/0.025% | 17 Dec, 2010 | 1 | 12 Jun, 2015 | 03 Aug, 2020 | Deferred |
Alternative Brands for Ziana
Ziana which is used for treating acne vulgaris in patients 12 years or older., has several other brand drugs in the same treatment category and using the same active ingredient (Clindamycin Phosphate; Tretinoin). 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 | ||||
|---|---|---|---|---|---|---|
| Almirall |
| |||||
| Bausch |
| |||||
| Galderma Labs Lp |
| |||||
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. Clindamycin Phosphate; Tretinoin. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Almirall |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clindamycin Phosphate; Tretinoin, Ziana's active ingredient. Check the complete list of approved generic manufacturers for Ziana
About Ziana
Ziana is a drug owned by Bausch Health Us Llc. It is used for treating acne vulgaris in patients 12 years or older. Ziana uses Clindamycin Phosphate; Tretinoin as an active ingredient. Ziana was launched by Bausch in 2006.
Approval Date:
Ziana was approved by FDA for market use on 07 November, 2006.
Active Ingredient:
Ziana uses Clindamycin Phosphate; Tretinoin as the active ingredient. Check out other Drugs and Companies using Clindamycin Phosphate; Tretinoin ingredient
Treatment:
Ziana is used for treating acne vulgaris in patients 12 years or older.
Dosage:
Ziana is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.2%;0.025% | GEL | Prescription | TOPICAL |