Desonate is a drug owned by Leo Pharma As. 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 Aug 03, 2020. Details of Desonate'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
|
US patents provide insights into the exclusivity only within the United States, but Desonate 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 Desonate's family patents as well as insights into ongoing legal events on those patents.
Desonate's Family Patents
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Generic Launch
Generic Release Date:
Desonate'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)
Desonate Generic API suppliers:
Desonide is the generic name for the brand Desonate. 12 different companies have already filed for the generic of Desonate, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Desonate's generic
How can I launch a generic of Desonate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Desonate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Desonate'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 Desonate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 01 Dec, 2010 | 1 | 11 May, 2020 | 03 Aug, 2020 | Deferred |
Alternative Brands for Desonate
Desonate which is used for treating mild to moderate atopic dermatitis in patients 3 months of age and older., has several other brand drugs using the same active ingredient (Desonide). 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 | |||||
|---|---|---|---|---|---|---|
| Almirall |
| |||||
| Astrazeneca |
| |||||
| Astrazeneca Ab |
| |||||
| Calliditas |
| |||||
| Cheplapharm |
| |||||
| Padagis Us |
| |||||
| Salix |
| |||||
| Sun Pharm Inds Inc |
| |||||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Desonide, Desonate's active ingredient. Check the complete list of approved generic manufacturers for Desonate
About Desonate
Desonate is a drug owned by Leo Pharma As. It is used for treating mild to moderate atopic dermatitis in patients 3 months of age and older. Desonate uses Desonide as an active ingredient. Desonate was launched by Leo Pharma As in 2006.
Approval Date:
Desonate was approved by FDA for market use on 20 October, 2006.
Active Ingredient:
Desonate uses Desonide as the active ingredient. Check out other Drugs and Companies using Desonide ingredient
Treatment:
Desonate is used for treating mild to moderate atopic dermatitis in patients 3 months of age and older.
Dosage:
Desonate is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | TOPICAL |