Fortical is a drug owned by Upsher Smith Laboratories Llc. It is protected by 3 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 Feb 02, 2021. Details of Fortical'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). | |||
| USRE40812 | Nasal calcitonin formulation |
Feb, 2021
(3 years ago) |
Expired
|
| USRE43580 | Nasal calcitonin formulations |
Feb, 2021
(3 years ago) |
Expired
|
| US6440392 | Nasal calcitonin formulations |
Feb, 2021
(3 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 Fortical's patents.
Latest Legal Activities on Fortical's Patents
Given below is the list of recent legal activities going on the following patents of Fortical.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 28 Sep, 2011 | US6440392 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Sep, 2011 | US6440392 |
| Correspondence Address Change Critical | 26 Sep, 2011 | US6440392 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 21 Nov, 2005 | US6440392 |
| Recordation of Patent Grant Mailed Critical | 27 Aug, 2002 | US6440392 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Aug, 2002 | US6440392 |
| Issue Notification Mailed Critical | 08 Aug, 2002 | US6440392 |
| Receipt into Pubs | 02 Aug, 2002 | US6440392 |
| Receipt into Pubs | 29 Jul, 2002 | US6440392 |
| Application Is Considered Ready for Issue Critical | 16 Jul, 2002 | US6440392 |
US patents provide insights into the exclusivity only within the United States, but Fortical 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 Fortical's family patents as well as insights into ongoing legal events on those patents.
Fortical's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fortical's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 02, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fortical Generics:
There are no approved generic versions for Fortical as of now.
How can I launch a generic of Fortical before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fortical's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fortical'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 Fortical -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 IU/spray | 29 Mar, 2006 | 1 | 02 Feb, 2021 | Extinguished |
Alternative Brands for Fortical
Fortical which is used for treating nasal conditions such as congestion or allergies. ., has several other brand drugs in the same treatment category . 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 | ||
|---|---|---|---|---|
| Norvium Bioscience |
| |||
About Fortical
Fortical is a drug owned by Upsher Smith Laboratories Llc. It is used for treating nasal conditions such as congestion or allergies. . Fortical uses Calcitonin Salmon Recombinant as an active ingredient. Fortical was launched by Upsher Smith Labs in 2005.
Approval Date:
Fortical was approved by FDA for market use on 12 August, 2005.
Active Ingredient:
Fortical uses Calcitonin Salmon Recombinant as the active ingredient. Check out other Drugs and Companies using Calcitonin Salmon Recombinant ingredient
Treatment:
Fortical is used for treating nasal conditions such as congestion or allergies. .
Dosage:
Fortical is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |