Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Colorcon
Merck
Express Scripts
Boehringer Ingelheim

Last Updated: August 11, 2022

OMNARIS Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

< Available with Subscription >

  Try it Free

Summary for OMNARIS
Drug patent expirations by year for OMNARIS
Drug Prices for OMNARIS

See drug prices for OMNARIS

DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 2/Phase 3
AstraZenecaPhase 3
TakedaPhase 3

See all OMNARIS clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 See Plans and Pricing See Plans and Pricing
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 See Plans and Pricing See Plans and Pricing
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 See Plans and Pricing See Plans and Pricing
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 See Plans and Pricing See Plans and Pricing
>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

When does loss-of-exclusivity occur for OMNARIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04271744
Estimated Expiration: See Plans and Pricing

Canada

Patent: 38419
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0140257
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17371
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 70482
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 70482
Estimated Expiration: See Plans and Pricing

Japan

Patent: 18452
Estimated Expiration: See Plans and Pricing

Patent: 07505829
Estimated Expiration: See Plans and Pricing

Patent: 12197306
Estimated Expiration: See Plans and Pricing

Poland

Patent: 70482
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 70482
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 70482
Estimated Expiration: See Plans and Pricing

Spain

Patent: 52691
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OMNARIS around the world.

Country Patent Number Title Estimated Expiration
Belgium 1005876 NIEUWE PREGNA-1,4-DIEEN-3,20-DION-16-17-ACETAAL-21 ESTERS, WERKWIJZE VOOR EEN BEREIDING, PREPARAAT EN WERKWIJZE VOOR DE BEHANDELING VAN ONTSTEKINGSCONDITIES. See Plans and Pricing
Norway 20021866 See Plans and Pricing
Hong Kong 1050858 See Plans and Pricing
Czech Republic 20021238 See Plans and Pricing
Czech Republic 297780 Vodný farmaceutický prostredek (Aqueous pharmaceutical composition) See Plans and Pricing
Iceland 5312 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Colorcon
AstraZeneca
Harvard Business School
Johnson and Johnson

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.