Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 24, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022004

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NDA 022004 describes OMNARIS, which is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from two suppliers. There are five patents 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. Two suppliers are listed for this compound. Additional details are available on the ciclesonide profile page.
Summary for 022004
Tradename:OMNARIS
Applicant:Covis Pharma Bv
Ingredient:ciclesonide
Patents:5
Formulation / Manufacturing:see details
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 Sunovion Pharmaceuticals Inc. 63402-701 63402-701-01 1 POUCH in 1 CARTON (63402-701-01) > 1 BOTTLE, SPRAY in 1 POUCH > 120 SPRAY in 1 BOTTLE, SPRAY
OMNARIS ciclesonide SPRAY, METERED;NASAL 022004 NDA Sunovion Pharmaceuticals Inc. 63402-701 63402-701-02 1 POUCH in 1 CARTON (63402-701-02) > 1 BOTTLE, SPRAY in 1 POUCH > 60 SPRAY in 1 BOTTLE, SPRAY
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/INH
Approval Date:Oct 20, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 21, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 21, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022004

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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