Aldara 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 Oct 01, 2024. Details of Aldara's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7696159 | Treatment for basal cell carcinoma |
Apr, 2024
(1 year, 2 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7696159 (Pediatric) | Treatment for basal cell carcinoma |
Oct, 2024
(8 months 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 Aldara's patents.
Latest Legal Activities on Aldara's Patents
Given below is the list of recent legal activities going on the following patents of Aldara.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 14 May, 2018 | US7696159 |
| Maintenance Fee Reminder Mailed Critical | 27 Nov, 2017 | US7696159 |
| Email Notification Critical | 27 Mar, 2012 | US7696159 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Mar, 2012 | US7696159 |
| Correspondence Address Change Critical | 23 Mar, 2012 | US7696159 |
| Correspondence Address Change Critical | 21 Apr, 2010 | US7696159 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Apr, 2010 | US7696159 |
| Recordation of Patent Grant Mailed Critical | 13 Apr, 2010 | US7696159 |
| Issue Notification Mailed Critical | 24 Mar, 2010 | US7696159 |
| Dispatch to FDC | 15 Mar, 2010 | US7696159 |
US patents provide insights into the exclusivity only within the United States, but Aldara 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 Aldara's family patents as well as insights into ongoing legal events on those patents.
Aldara's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aldara's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 01, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aldara Generic API suppliers:
Imiquimod is the generic name for the brand Aldara. 8 different companies have already filed for the generic of Aldara, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aldara's generic
How can I launch a generic of Aldara before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aldara's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aldara'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 Aldara -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.05 | 17 Oct, 2006 | 1 | 25 Feb, 2010 | 24 Aug, 2010 | Eligible |
Alternative Brands for Aldara
Aldara which is used for boosting the immune response., has several other brand drugs using the same active ingredient (Imiquimod). 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 | |
|---|---|---|
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Imiquimod, Aldara's active ingredient. Check the complete list of approved generic manufacturers for Aldara
About Aldara
Aldara is a drug owned by Bausch Health Us Llc. It is used for boosting the immune response. Aldara uses Imiquimod as an active ingredient. Aldara was launched by Bausch in 1997.
Approval Date:
Aldara was approved by FDA for market use on 27 February, 1997.
Active Ingredient:
Aldara uses Imiquimod as the active ingredient. Check out other Drugs and Companies using Imiquimod ingredient
Treatment:
Aldara is used for boosting the immune response.
Dosage:
Aldara is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM | Discontinued | TOPICAL |