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Last Updated: October 20, 2021

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Details for New Drug Application (NDA): 022004


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NDA 022004 describes OMNARIS, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the OMNARIS profile page.

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.
Summary for 022004
Tradename:OMNARIS
Applicant:Covis
Ingredient:ciclesonide
Patents:1
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 022004
Generic Entry Date for 022004*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 022004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMNARIS ciclesonide SPRAY, METERED;NASAL 022004 NDA Covis Pharma 70515-701 70515-701-01 1 POUCH in 1 CARTON (70515-701-01) > 1 BOTTLE, GLASS in 1 POUCH > 120 SPRAY in 1 BOTTLE, GLASS
Paragraph IV (Patent) Challenges for 022004
Tradename Dosage Ingredient NDA Submissiondate
OMNARIS SPRAY, METERED;NASAL ciclesonide 022004 2012-02-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.05MG/SPRAY
Approval Date:Oct 20, 2006TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Feb 1, 2028Product Flag?Substance Flag?Delist Request?
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

Expired US Patents for NDA 022004

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

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