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Last Updated: June 19, 2021

DrugPatentWatch Database Preview

OMNARIS Drug 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
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
TakedaPhase 3
SunovionPhase 4
West Penn Allegheny Health SystemPhase 4

See all OMNARIS clinical trials

Paragraph IV (Patent) Challenges for OMNARIS
Tradename Dosage Ingredient NDA Submissiondate
OMNARIS SPRAY, METERED;NASAL ciclesonide 022004 2012-02-13

US Patents and Regulatory Information for OMNARIS

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   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Get Started Free   Get Started Free
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Get Started Free   Get Started Free
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Get Started Free   Get Started Free
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

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