Omnaris is a drug owned by Covis Pharma Gmbh. It is protected by 6 US drug patents filed in 2013. Out of these, 1 drug patents are active and 5 have expired. Omnaris's patents have been open to challenges since 20 October, 2010. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 01, 2028. Details of Omnaris'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). | |||
| US8371292 | Use of ciclesonide for the treatment of respiratory diseases |
Feb, 2028
(2 years from now) | Active |
| US6767901 | Ciclesonide contained pharmaceutical composition for application to mucosa |
Oct, 2020
(4 years ago) |
Expired
|
| US8383611 | Ciclesonide containing aqueous pharmaceutical composition |
Oct, 2020
(4 years ago) |
Expired
|
| US7235247 | Pharmaceutical composition for application to mucosa |
Apr, 2019
(6 years ago) |
Expired
|
| US6939559 | Pharmaceutical composition for application to mucosa |
Apr, 2019
(6 years ago) |
Expired
|
| US5482934 | Pregna-1,4-diene3,20-dione-16-17-acetal-21 esters, process for their preparation, composition, and methods for the treatment of inflammatory conditions |
Oct, 2017
(7 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 Omnaris's patents.
Latest Legal Activities on Omnaris's Patents
Given below is the list of recent legal activities going on the following patents of Omnaris.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Aug, 2020 | US8383611 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jul, 2020 | US8371292 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Dec, 2018 | US7235247 |
| Post Issue Communication - Certificate of Correction | 07 Oct, 2014 | US8371292 |
| Email Notification Critical | 09 Aug, 2014 | US8371292 |
| Mail-Petition Decision - Dismissed Critical | 05 Aug, 2014 | US8371292 |
| Petition Decision - Dismissed Critical | 04 Aug, 2014 | US8371292 |
| Adjustment of PTA Calculation by PTO | 03 Aug, 2014 | US8371292 |
| Petition Entered | 01 Mar, 2013 | US8371292 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Feb, 2013 | US8383611 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Omnaris and ongoing litigations to help you estimate the early arrival of Omnaris generic.
Omnaris's Litigations
Omnaris been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 23, 2009, against patent number US8383611. The petitioner , challenged the validity of this patent, with Atsuhiro Nagano et al as the respondent. Click below to track the latest information on how companies are challenging Omnaris's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8383611 | November, 2009 |
Decision
(22 Feb, 2011) | Atsuhiro Nagano et al | |
FDA has granted some exclusivities to Omnaris. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Omnaris, 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 Omnaris.
Exclusivity Information
Omnaris holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Omnaris's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 20, 2011 |
Several oppositions have been filed on Omnaris's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Omnaris's generic, the next section provides detailed information on ongoing and past EP oppositions related to Omnaris patents.
Omnaris's Oppositions Filed in EPO
Omnaris has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 25, 2014, by Generics [Uk] Ltd (Trading As Mylan). This opposition was filed on patent number EP04766791A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP04766791A | Sep, 2014 | Generics [UK] Ltd (trading as Mylan) | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Omnaris 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 Omnaris's family patents as well as insights into ongoing legal events on those patents.
Omnaris's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Omnaris's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 01, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Omnaris Generics:
There are no approved generic versions for Omnaris as of now.
How can I launch a generic of Omnaris before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Omnaris's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Omnaris'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 Omnaris -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mcg | 13 Feb, 2012 | 1 | 21 Oct, 2020 | Extinguished |
Alternative Brands for Omnaris
Omnaris which is used for relieving nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children., has several other brand drugs in the same treatment category and using the same active ingredient (Ciclesonide). 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 | ||
|---|---|---|---|---|
| Astrazeneca |
| |||
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. Ciclesonide. Given below is the list of those drugs and companies owning them.
About Omnaris
Omnaris is a drug owned by Covis Pharma Gmbh. It is used for relieving nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children. Omnaris uses Ciclesonide as an active ingredient. Omnaris was launched by Covis in 2006.
Approval Date:
Omnaris was approved by FDA for market use on 20 October, 2006.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Omnaris is 20 October, 2006, its NCE-1 date is estimated to be 20 October, 2010.
Active Ingredient:
Omnaris uses Ciclesonide as the active ingredient. Check out other Drugs and Companies using Ciclesonide ingredient
Treatment:
Omnaris is used for relieving nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children.
Dosage:
Omnaris 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 | SPRAY, METERED | Prescription | NASAL |