Cutivate is a drug owned by Fougera Pharmaceuticals 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 Oct 20, 2019. Details of Cutivate'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). | |||
| US7300669 | Fluticasone lotion having improved vasoconstrictor activity |
Oct, 2019
(5 years 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 Cutivate's patents.
Latest Legal Activities on Cutivate's Patents
Given below is the list of recent legal activities going on the following patents of Cutivate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 May, 2019 | US7300669 |
| Email Notification Critical | 07 Oct, 2011 | US7300669 |
| Grant Request for Retroactive License | 21 Sep, 2011 | US7300669 |
| Email Notification Critical | 31 May, 2011 | US7300669 |
| Change in Power of Attorney (May Include Associate POA) Critical | 31 May, 2011 | US7300669 |
| Correspondence Address Change Critical | 26 May, 2011 | US7300669 |
| Request for Retroactive License | 23 Dec, 2010 | US7300669 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Nov, 2007 | US7300669 |
| Recordation of Patent Grant Mailed Critical | 27 Nov, 2007 | US7300669 |
| Issue Notification Mailed Critical | 07 Nov, 2007 | US7300669 |
FDA has granted several exclusivities to Cutivate. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cutivate, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Cutivate.
Exclusivity Information
Cutivate holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Cutivate's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jan 16, 2018 |
US patents provide insights into the exclusivity only within the United States, but Cutivate 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 Cutivate's family patents as well as insights into ongoing legal events on those patents.
Cutivate's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cutivate's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 20, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cutivate Generic API suppliers:
Fluticasone Propionate is the generic name for the brand Cutivate. 13 different companies have already filed for the generic of Cutivate, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cutivate's generic
How can I launch a generic of Cutivate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cutivate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cutivate'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 Cutivate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 28 Jul, 2008 | 1 | 02 May, 2011 | 20 Oct, 2019 | Eligible |
Alternative Brands for Cutivate
Cutivate which is used for treating the inflammatory and pruritic manifestations of atopic dermatitis in patients one year of age or older., has several other brand drugs using the same active ingredient (Fluticasone Propionate). 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Glaxo Grp Ltd |
| ||||||||
| Mylan Speciality Lp |
| ||||||||
| Optinose Us Inc |
| ||||||||
| Teva Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluticasone Propionate, Cutivate's active ingredient. Check the complete list of approved generic manufacturers for Cutivate
About Cutivate
Cutivate is a drug owned by Fougera Pharmaceuticals Inc. It is used for treating the inflammatory and pruritic manifestations of atopic dermatitis in patients one year of age or older. Cutivate uses Fluticasone Propionate as an active ingredient. Cutivate was launched by Fougera Pharms in 2005.
Approval Date:
Cutivate was approved by FDA for market use on 31 March, 2005.
Active Ingredient:
Cutivate uses Fluticasone Propionate as the active ingredient. Check out other Drugs and Companies using Fluticasone Propionate ingredient
Treatment:
Cutivate is used for treating the inflammatory and pruritic manifestations of atopic dermatitis in patients one year of age or older.
Dosage:
Cutivate is available in lotion 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** | LOTION | Discontinued | TOPICAL |