Nasonex is a drug owned by Organon Llc. It is protected by 6 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 Apr 03, 2018. Details of Nasonex'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). | |||
|
US6127353 (Pediatric) | Mometasone furoate monohydrate, process for making same and pharmaceutical compositions |
Apr, 2018
(6 years ago) |
Expired
|
| US6127353 | Mometasone furoate monohydrate, process for making same and pharmaceutical compositions |
Oct, 2017
(7 years ago) |
Expired
|
|
US5837699 (Pediatric) | Use of mometasone furoate for treating upper airway passage diseases |
Jul, 2014
(10 years ago) |
Expired
|
|
US6723713 (Pediatric) | Use of mometasone furoate for treating upper airway diseases |
Jul, 2014
(10 years ago) |
Expired
|
| US6723713 | Use of mometasone furoate for treating upper airway diseases |
Jan, 2014
(10 years ago) |
Expired
|
| US5837699 | Use of mometasone furoate for treating upper airway passage diseases |
Jan, 2014
(10 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 Nasonex's patents.
Latest Legal Activities on Nasonex's Patents
Given below is the list of recent legal activities going on the following patents of Nasonex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 13 May, 2016 | US6723713 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US6723713 |
| Post Issue Communication - Certificate of Correction | 23 Mar, 2005 | US6723713 |
| Recordation of Patent Grant Mailed Critical | 20 Apr, 2004 | US6723713 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Apr, 2004 | US6723713 |
| Issue Notification Mailed Critical | 01 Apr, 2004 | US6723713 |
| Receipt into Pubs | 17 Mar, 2004 | US6723713 |
| Application Is Considered Ready for Issue Critical | 15 Mar, 2004 | US6723713 |
| Receipt into Pubs | 04 Mar, 2004 | US6723713 |
| Issue Fee Payment Received Critical | 20 Jan, 2004 | US6723713 |
FDA has granted several exclusivities to Nasonex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nasonex, 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 Nasonex.
Exclusivity Information
Nasonex holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Nasonex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-626) | May 26, 2013 |
| M(M-99) | Jan 19, 2014 |
US patents provide insights into the exclusivity only within the United States, but Nasonex 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 Nasonex's family patents as well as insights into ongoing legal events on those patents.
Nasonex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nasonex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 03, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nasonex Generic API suppliers:
Mometasone Furoate is the generic name for the brand Nasonex. 14 different companies have already filed for the generic of Nasonex, with Cosette having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nasonex's generic
How can I launch a generic of Nasonex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nasonex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nasonex'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 Nasonex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mcg/ Spray | 07 Aug, 2009 | 1 | 22 Mar, 2016 | 03 Oct, 2017 | Deferred |
Alternative Brands for Nasonex
Nasonex which is used for treating allergic rhinitis and nasal polyps., has several other brand drugs using the same active ingredient (Mometasone Furoate). 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 | |||
|---|---|---|---|---|
| Glenmark Speclt |
| |||
| Intersect Ent Inc |
| |||
| Organon Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mometasone Furoate, Nasonex's active ingredient. Check the complete list of approved generic manufacturers for Nasonex
About Nasonex
Nasonex is a drug owned by Organon Llc. It is used for treating allergic rhinitis and nasal polyps. Nasonex uses Mometasone Furoate as an active ingredient. Nasonex was launched by Organon Llc in 1997.
Approval Date:
Nasonex was approved by FDA for market use on 01 October, 1997.
Active Ingredient:
Nasonex uses Mometasone Furoate as the active ingredient. Check out other Drugs and Companies using Mometasone Furoate ingredient
Treatment:
Nasonex is used for treating allergic rhinitis and nasal polyps.
Dosage:
Nasonex is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |