Duac is a drug owned by Stiefel Laboratories Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 16, 2014. Details of Duac'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). | |||
| US5466446 | Topical compositions containing bensoyl peroxide and clindamycin and method of use thereof |
Feb, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Duac 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 Duac's family patents as well as insights into ongoing legal events on those patents.
Duac's Family Patents
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Generic Launch
Generic Release Date:
Duac's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 16, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Duac Generic API suppliers:
Benzoyl Peroxide; Clindamycin Phosphate is the generic name for the brand Duac. 8 different companies have already filed for the generic of Duac, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Duac's generic
How can I launch a generic of Duac before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Duac's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Duac'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 Duac -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1% / 5% | 11 Dec, 2008 | 1 | 26 Jun, 2012 | 14 Nov, 2012 | Deferred |
Alternative Brands for Duac
There are several other brand drugs using the same active ingredient (Benzoyl Peroxide; Clindamycin Phosphate) as Duac. 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 brand drugs containing the same ingredient, some generics have also been filed for Benzoyl Peroxide; Clindamycin Phosphate, Duac's active ingredient. Check the complete list of approved generic manufacturers for Duac
About Duac
Duac is a drug owned by Stiefel Laboratories Inc. Duac uses Benzoyl Peroxide; Clindamycin Phosphate as an active ingredient. Duac was launched by Stiefel in 2002.
Approval Date:
Duac was approved by FDA for market use on 26 August, 2002.
Active Ingredient:
Duac uses Benzoyl Peroxide; Clindamycin Phosphate as the active ingredient. Check out other Drugs and Companies using Benzoyl Peroxide; Clindamycin Phosphate ingredient
Dosage:
Duac is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5%;1.2% | GEL | Prescription | TOPICAL |