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Last Updated: August 14, 2020

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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 Pharma Bv and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seven patent family members in thirty-six 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.

US ANDA Litigation and Generic Entry Outlook for Omnaris

Omnaris was eligible for patent challenges on October 20, 2010.

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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Drug patent expirations by year for OMNARIS
Drug Prices for OMNARIS

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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 Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start 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 Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Start Trial   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Start Trial   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Colorcon
AstraZeneca
Harvard Business School
Johnson and Johnson

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