OMNARIS Drug Patent Profile
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Which patents cover Omnaris, and when can generic versions of Omnaris launch?
Omnaris is a drug marketed by Covis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has fourteen patent family members in twelve countries.
The generic ingredient in OMNARIS is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.
DrugPatentWatch® Generic Entry Outlook for Omnaris
Omnaris was eligible for patent challenges on October 20, 2010.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Summary for OMNARIS
| International Patents: | 14 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,292 |
| Drug Prices: | Drug price information for OMNARIS |
| What excipients (inactive ingredients) are in OMNARIS? | OMNARIS excipients list |
| DailyMed Link: | OMNARIS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OMNARIS
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for OMNARIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 2/Phase 3 |
| Takeda | Phase 3 |
| AstraZeneca | Phase 3 |
Paragraph IV (Patent) Challenges for OMNARIS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OMNARIS | Nasal Spray | ciclesonide | 50 mcg | 022004 | 1 | 2012-02-13 |
US Patents and Regulatory Information for OMNARIS
OMNARIS is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OMNARIS is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting OMNARIS
Use of ciclesonide for the treatment of respiratory diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF NASAL SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER. TREATMENT OF NASAL SYMPTOMS ASSOCIATED W PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OMNARIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OMNARIS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim Vetmedica GmbH | Aservo EquiHaler | ciclesonide | EMEA/V/C/004991 For the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction – (RAO), Summer Pasture Associated Recurrent Airway Obstruction – (SPA-RAO)). |
Authorised | no | no | no | 2020-01-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OMNARIS
See the table below for patents covering OMNARIS around the world.
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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