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OMNARIS

NDA

CICLESONIDE | N022004 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

8371292

Feb. 1, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

70 trials from ClinicalTrials.gov, 68 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)NCT00163423	Phase 3	Completed	AstraZeneca	480	2004-11 → 2006-01
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)NCT00163462	Phase 3	Completed	AstraZeneca	750	2004-10 → 2005-11
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.NCT00392288	Phase 3	Completed	AstraZeneca	528	2006-09 → 2008-02
To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)NCT00659750	Phase 3	Completed	AstraZeneca	418	2003-12 → 2005-04
A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler NCT01371786	Phase 1	Completed	Sumitomo Pharma America, Inc.	14	2011-06 → 2011-08
Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)NCT00163345	Phase 3	Completed	AstraZeneca	20	2003-09 → 2006-05
Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)NCT00163384	Phase 3	Completed	AstraZeneca	240	2004-01 → 2005-05
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)NCT00163488	Phase 3	Completed	AstraZeneca	106	2005-01 → 2005-08
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Butylated Hydroxytoluene and BI 54903 XX Via Respimat® Soft MistTM Inhaler B in Healthy Male Volunteers NCT02221375	Phase 1	Completed	Boehringer Ingelheim	56	2008-06
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)NCT00163319	Phase 3	Completed	AstraZeneca	500	2004-11 → 2005-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$22.56

per gm

Lowest NADAC/Unit

$22.56

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70515070101OMNARIS 50 MCG NASAL SPRAY	$22.56	GM	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$184.37

Highest Price

$184.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70515-0701-01OMNARIS 50MCG/SPRAY INHL,NASAL,12.5GM	$184.37	FSS	Covis Pharm S.a.r.l., Bertrange, Zug Branch	06/30/2026
70515-0701-01OMNARIS 50MCG/SPRAY INHL,NASAL,12.5GM	$184.37	Big4	Covis Pharm S.a.r.l., Bertrange, Zug Branch	06/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Omnaris (2024)

Total Spending

$858K

Total Claims

1,855

Beneficiaries

590

Avg Cost/Unit

$22.87

Spending Trend

$1.5M(2019)→$1.5M(2020)→$1.3M(2021)→$1.2M(2022)→$923K(2023)→$858K(2024)

YoY Change:-4.8%

5yr CAGR:-0.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs2 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIKCICLESONIDE

DMF 166062003

STERLING SPACICLESONIDE

DMF 225872009

AARTI PHARMALABS LTDCICLESONIDE

DMF 236502010

CORAL DRUGS PVT LTDCICLESONIDE

DMF 382832023

NEWCHEM SPACICLESONIDE

DMF 422892025

MICRONISIERUNGS KONTOR OBERROT GMBHInactiveCICLESONIDE, MICRONIZED (ITEM NO. 37)

DMF 190282005

ALP PHARM BEIJING CO LTDInactiveCICLESONIDE

DMF 242552010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 13, 2019	SUPPL -18	View Letter (PDF)
Mar 21, 2016	SUPPL -15	View Letter (PDF)
Mar 26, 2013	SUPPL -13	View Letter (PDF)
May 12, 2010	SUPPL -7	View Letter (PDF)
May 12, 2010	SUPPL -5	View Letter (PDF)
Nov 26, 2007	SUPPL -2	View Letter (PDF)
Oct 26, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05MG/SPRAY

RLD

1 patent0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Oct 20, 2006

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8371292	Feb 1, 2028	—	—	—		—