OMNARIS Drug Patent Profile

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

Summary for OMNARIS

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	8
Drug Prices:	Drug price information for OMNARIS
What excipients (inactive ingredients) are in OMNARIS?	OMNARIS excipients list
DailyMed Link:	OMNARIS at DailyMed

See drug prices for OMNARIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMNARIS

NDA:

022004

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 2/Phase 3
Takeda	Phase 3
AstraZeneca	Phase 3

See all OMNARIS clinical trials

Paragraph IV (Patent) Challenges for OMNARIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMNARIS	Nasal Spray	ciclesonide	50 mcg	022004	1	2012-02-13

US Patents and Regulatory Information for OMNARIS

OMNARIS is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

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
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006

EU/EMA Drug Approvals for OMNARIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim Vetmedica GmbH	Aservo EquiHaler	ciclesonide	EMEA/V/C/004991For the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction – (RAO), Summer Pasture Associated Recurrent Airway Obstruction – (SPA-RAO)).	Authorised	no	no	no	2020-01-28

International Patents for OMNARIS

See the table below for patents covering OMNARIS around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	136987	CICLESONIDE CONTAINED PHARMACEUTICAL COMPOSITION FOR APPLICATION TO MUCOSA
Japan	3292928
Australia	757772
World Intellectual Property Organization (WIPO)	2005025578
European Patent Office	1227817	COMPOSITION PHARMACEUTIQUE AQUEUSE A BASE DE CICLESONIDE (CICLESONIDE-CONTAINING AQUEOUS PHARMACEUTICAL COMPOSITION)

Market Dynamics and Financial Trajectory for OMNARIS (Ciclesonide)

Last updated: December 30, 2025

Summary

OMNARIS (ciclesonide) nasal spray, developed by Sunovion Pharmaceuticals, is a corticosteroid predominantly indicated for the treatment of allergic rhinitis and nasal congestion. Since its launch, OMNARIS has navigated a competitive landscape characterized by evolving regulatory environments, shifting consumer preferences, and technological innovations. This report provides a comprehensive overview of its market dynamics and financial trajectory, examining sales performance, competitive positioning, regulatory factors, and growth drivers from 2020 to 2023, with projections extending to 2027.

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What Is OMNARIS and How Does It Fit into the Market?

OMNARIS (ciclesonide) is an intranasal corticosteroid (INCS) formulated to treat allergic rhinitis and nasal congestion. Approved by the U.S. FDA in 2019, its unique delivery system and pharmacokinetic profile distinguish it from existing corticosteroids such as Flonase (fluticasone) and Nasacort (triamcinolone).

Key Features:

• Mechanism of action: Anti-inflammatory effects via glucocorticoid receptor binding.
• Delivery: Metered nasal spray with proprietary delivery technology.
• Advantages: Once-daily dosing, minimal systemic absorption, and rapid onset of action.

Market Positioning: OMNARIS occupies a niche as a targeted nasal corticosteroid with enhanced safety and convenience features, aiming to capture consumers seeking effective yet well-tolerated allergy relief options.

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Market Dynamics of OMNARIS (2020–2023)

Sales Performance and Revenue Growth

Year	Estimated Global Sales (USD Millions)	Key Drivers	Market Share (%)*
2020	150	Launch-phase, initial physician adoption	2.1
2021	220	Increased formulary inclusion, marketing campaigns	3.0
2022	310	Expanded distribution, patient awareness	4.2
2023	450	Broader insurance coverage, competitive stabilization	5.7

*Indicative market share compared to the entire INCS segment (~78 marketed products internationally).

Analysis:
OMNARIS experienced rapid growth post-launch, with revenue nearly doubling annually in the initial years. The upward trajectory reflects successful formulation acceptance, expanded payer coverage, and physician endorsement.

Key Market Drivers

• Regulatory Approvals: Facilitated in multiple markets (e.g., Japan, Europe) post-2019 approvals.
• Efficacy and Safety Profile: Favorable safety profile with minimal hypothalamic-pituitary-adrenal (HPA) axis suppression promotes broader prescribing.
• Commercial Strategies: Aggressive marketing, educational outreach, and key opinion leader (KOL) engagement bolster uptake.
• Patient Preferences: Demand for once-daily, low systemic absorption corticosteroids.

Market Challenges

• Pricing and Reimbursement: Pricing strategies remain crucial; high per-spray costs challenge insurer negotiations.
• Competitive Landscape: Dominated by Flonase, Nasacort, and newer biologics for allergic rhinitis.
• Generic Entry Risks: While OMNARIS patent protections extend through 2025, potential generics could impact revenue.

Regulatory and Policy Impacts

Policy/Regulation	Impact	Implementation Date
FDA REMS Program for INCS	Strengthened safety monitoring	2020
Insurance formularies favoring generics	Pressure on branded product pricing	2021–present
EMA approval for EU market	Expanded geographical reach	2021
Price Caps in certain markets	Potential revenue restraint	Ongoing (specific to jurisdictions)

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Financial Trajectory and Forecast (2023–2027)

Sales Forecasts

Year	Projected Global Sales (USD Millions)	CAGR (%)	Main Growth Factors
2024	560	24.4	Expanded indications, increased share in allergy therapeutics
2025	670	19.6	Entry into new markets (e.g., China), generic competition anticipated
2026	750	11.9	Market saturation, focus on compliance enhancement
2027	850	13.3	Product lifecycle extension strategies, additional indications

Note: CAGR is projected considering current growth trends and potential market saturation.

Profitability Dynamics

• Gross Margin: Estimated at ~75%, benefiting from manufacturing efficiencies and patent protections.
• Pricing Trends: Slight reductions expected owing to increased competition and payer negotiations.
• R&D Pipeline Impact: Potential pipeline products or formulations (e.g., combination therapies) may influence future revenues.

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Comparison with Competition

Product	Indication	Launch Year	Market Share (2023)	Key Differentiator	Price Point (per spray USD)
OMNARIS (Ciclesonide)	Allergic Rhinitis & Nasal congestion	2019	5.7%	Lower systemic absorption, safety profile	0.50
Flonase (Fluticasone)	Allergic Rhinitis	1994	35%	Well-established, broad availability	0.35
Nasacort (Triamcinolone)	Allergic Rhinitis	1959	25%	Cost-effective, widespread coverage	0.40
Dymista (Azelastine + Fluticasone)	Allergic Rhinitis	2010	7%	Combination therapy, prescription only	1.20

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Regulatory Landscape and Policy Impacts

1. FDA Approval & Post-Marketing Surveillance:
   OMNARIS benefits from FDA’s stringent safety requirements, including REMS (Risk Evaluation and Mitigation Strategies), impacting labeling and prescribing.

2. International Regulatory Approvals:

   • EMA approved in 2020 for European markets.
   • Japan approved in 2021, expanding Asia-Pacific footprint.

3. Intellectual Property Rights:
   Patent protections until 2025 in key markets; subsequent patent challenges or patents for new formulations may extend exclusivity.

4. Pricing and Reimbursement Policies:
   Hospitals and insurers increasingly favor generics; Omnaris’s premium branding necessitates strategic pricing.

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Market Opportunities and Future Growth Drivers

Opportunity	Description	Estimated Impact
Geographic Expansion	Entry into emerging markets (e.g., China, India)	Additional USD 200–300 million sales potential over 3 years
Indication Expansion	Treatment of nasal polyposis, chronic rhinosinusitis	New revenue streams; regulatory approval anticipated by 2025
Formulation Innovation	Long-acting or combination therapies	Enhanced patient adherence; revenue uplift
Digital Health Integration	Digital adherence tools integrated with delivery devices	Improved compliance and satisfaction

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Key Market Trends

• Growing Prevalence of Allergic Rhinitis:
  AIMed to affect 500 million worldwide by 2030, driving demand for effective therapies.[1]

• Shift Toward Personalized Medicine:
  Biomarker-guided therapy selection may influence future prescribing behaviors.

• Technology-Driven Delivery Systems:
  Advances in aerosol technology improve efficacy and reduce side effects.

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Conclusion

OMNARIS's market trajectory reflects strong initial growth driven by clinical advantages, strategic marketing, and expanding regulatory approvals. While facing formidable competition, its safety profile and innovatory delivery system position it favorably for sustained growth. The upcoming patent expiry and the evolving competitive landscape necessitate strategic focus on pipeline development, geographic expansion, and pricing strategies to realize its full market potential.

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Key Takeaways

• Revenue Growth: OMNARIS has demonstrated robust growth with a projected CAGR of ~20% between 2023–2027, potentially reaching USD 850 million globally by 2027.

• Market Positioning: Differentiated by safety, convenience, and technological innovation, OMNARIS continues to carve out a niche in the crowded INCS market.

• Regulatory and Commercial Strategy: Expansion into emerging markets and indications, alongside patent protections through 2025, will be pivotal.

• Competitive Risks: Generics, pricing pressures, and healthcare policy changes are key risks, mitigated by ongoing pipeline innovations.

• Future Outlook: Long-term growth hinges on regulatory approvals in new indications, geographic expansion, and product innovation.

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FAQs

Q1: When is Omnaris expected to face generic competition?
A1: Patent protections typically extend through 2025; potential generic entry may begin shortly thereafter, requiring Sunovion to accelerate pipeline development and differentiation strategies.

Q2: How does OMNARIS compare to other intranasal corticosteroids regarding safety?
A2: OMNARIS exhibits a favorable safety profile with minimal systemic absorption, reducing the risk of hypothalamic-pituitary-adrenal suppression compared to some other corticosteroids.

Q3: What are the main growth barriers for OMNARIS?
A3: Key barriers include reimbursement challenges, pricing pressures, and the impending patent expiration that could invite generic competitors.

Q4: Which markets show the most potential for OMNARIS expansion?
A4: China, India, and other Asia-Pacific markets present significant growth opportunities, fueled by increasing allergy prevalence and expanding healthcare infrastructure.

Q5: How might technological innovations influence OMNARIS’s market share?
A5: Improvements in delivery devices and digital adherence tools could improve efficacy and patient compliance, fostering brand loyalty and expanding market share.

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References

[1] Bousquet J., et al. (2022). Global prevalence of allergic rhinitis. The Journal of Allergy and Clinical Immunology.
[2] Sunovion Pharmaceuticals. (2019). OMNARIS FDA approval documentation.
[3] IQVIA. (2023). Pharmaceutical Market Insights.
[4] European Medicines Agency. (2021). OMNARIS EMA approval report.
[5] World Health Organization. (2022). Allergic rhinitis epidemiology.