Fortesta is a drug owned by Endo Operations Ltd. 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 Nov 09, 2018. Details of Fortesta'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). | |||
| US6319913 | Penetration enhancing and irritation reducing systems |
Nov, 2018
(6 years ago) |
Expired
|
| US6579865 | Penetration enhancing and irritation reducing systems |
Nov, 2018
(6 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 Fortesta's patents.
Latest Legal Activities on Fortesta's Patents
Given below is the list of recent legal activities going on the following patents of Fortesta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 17 Jun, 2003 | US6579865 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Jun, 2003 | US6579865 |
| Issue Notification Mailed Critical | 29 May, 2003 | US6579865 |
| Receipt into Pubs | 15 May, 2003 | US6579865 |
| Application Is Considered Ready for Issue Critical | 13 May, 2003 | US6579865 |
| Receipt into Pubs | 13 May, 2003 | US6579865 |
| Response to Amendment under Rule 312 Critical | 07 May, 2003 | US6579865 |
| Mail Response to 312 Amendment (PTO-271) Critical | 07 May, 2003 | US6579865 |
| Receipt into Pubs | 17 Apr, 2003 | US6579865 |
| Amendment after Notice of Allowance (Rule 312) Critical | 04 Mar, 2003 | US6579865 |
FDA has granted several exclusivities to Fortesta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fortesta, 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 Fortesta.
Exclusivity Information
Fortesta holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Fortesta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 29, 2013 |
US patents provide insights into the exclusivity only within the United States, but Fortesta 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 Fortesta's family patents as well as insights into ongoing legal events on those patents.
Fortesta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fortesta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 09, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fortesta Generic API suppliers:
Testosterone is the generic name for the brand Fortesta. 15 different companies have already filed for the generic of Fortesta, with Actavis Labs Ut Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fortesta's generic
How can I launch a generic of Fortesta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fortesta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fortesta'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 Fortesta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/actuation | 14 Aug, 2012 | 1 | 05 Aug, 2015 | 09 Nov, 2018 | Deferred |
Alternative Brands for Fortesta
Fortesta which is used for treating conditions associated with deficiency or absence of endogenous testosterone in males., has several other brand drugs in the same treatment category and using the same active ingredient (Testosterone). 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 | ||
|---|---|---|---|---|
| Besins Hlthcare |
| |||
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. Testosterone. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Acerus |
| ||
| Alza |
| ||
| Antares Pharma Inc |
| ||
| Auxilium Pharms Llc |
| ||
| Azurity |
| ||
| Eli Lilly And Co |
| ||
| Endo Operations |
| ||
| Marius Pharms Llc |
| ||
| Tolmar |
| ||
| Upsher Smith Labs |
| ||
| Verity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Testosterone, Fortesta's active ingredient. Check the complete list of approved generic manufacturers for Fortesta
About Fortesta
Fortesta is a drug owned by Endo Operations Ltd. It is used for treating conditions associated with deficiency or absence of endogenous testosterone in males. Fortesta uses Testosterone as an active ingredient. Fortesta was launched by Endo Operations in 2010.
Approval Date:
Fortesta was approved by FDA for market use on 29 December, 2010.
Active Ingredient:
Fortesta uses Testosterone as the active ingredient. Check out other Drugs and Companies using Testosterone ingredient
Treatment:
Fortesta is used for treating conditions associated with deficiency or absence of endogenous testosterone in males.
Dosage:
Fortesta is available in gel, metered form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/0.5GM ACTUATION | GEL, METERED | Discontinued | TRANSDERMAL |