OMNARIS Drug Patent Profile
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Which patents cover Omnaris, and what generic alternatives are available?
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. Two suppliers are 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
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: | 4,232 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OMNARIS |
What excipients (inactive ingredients) are in OMNARIS? | OMNARIS excipients list |
DailyMed Link: | OMNARIS at DailyMed |
![OMNARIS drug patent expirations Drug patent expirations by year for OMNARIS](/p/graph/s/t/OMNARIS-patent-expirations.png)
![Drug Prices for OMNARIS](/p/graph/drug-price/OMNARIS.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OMNARIS
Generic Entry Date for OMNARIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SPRAY, METERED;NASAL |
*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 |
AstraZeneca | Phase 3 |
Takeda | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for OMNARIS
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2034893 | PROCEDIMIENTO PARA LA OBTENCION DE NUEVOS PREGNA-1,4-DIENE-3,20-DIONE-16-17-ACETAL-21 ESTERES. | ⤷ Try a Trial |
Canada | 2388325 | COMPOSITION PHARMACEUTIQUE AQUEUSE A BASE DE CICLESONIDE (CICLESONIDE-CONTAINING AQUEOUS PHARMACEUTICAL COMPOSITION) | ⤷ Try a Trial |
Canada | 2388322 | COMPOSITION PHARMACEUTIQUE A BASE DE CICLESONIDE DESTINEE A LA MUQUEUSE (CICLESONIDE CONTAINED PHARMACEUTICAL COMPOSITION FOR APPLICATION TO MUCOSA) | ⤷ Try a Trial |
Netherlands | 194917 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |