OMNARIS Drug Patent Profile

Which patents cover Omnaris, and what generic alternatives are available?

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

Constraining patent/regulatory exclusivity:

8,371,292

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.

This potential generic entry date is based on patent 8,371,292.

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	8,371,292

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	5,482,934
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	8,383,611
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	7,235,247

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
Brazil	1100860
Australia	757772
Eurasian Patent Organization	005201	СОДЕРЖАЩАЯ ЦИКЛЕЗОНИД ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (CICLESONIDE-CONTAINING AQUEOUS PHARMACEUTICAL COMPOSITION)

Market Dynamics and Financial Trajectory for OMNARIS (Ciclesonide)

Last updated: July 27, 2025

Introduction

OMNARIS, a proprietary intranasal corticosteroid formulation of ciclesonide, has carved a niche within the allergy and upper respiratory disease market since its approval. Developed by Sunovion Pharmaceuticals (a subsidiary of Sumitomo Dainippon Pharma), OMNARIS stands as a pivotal treatment for allergic rhinitis and related conditions. Understanding its market dynamics and financial trajectory involves analyzing competitive positioning, regulatory landscape, clinical efficacy, market penetration strategies, and macroeconomic factors influencing its commercial success.

Market Overview and Segmentation

Therapeutic Market Scope

OMNARIS primarily targets allergic rhinitis and nasal polyposis, comprising an estimated global market worth approximately USD 3-4 billion annually, with a compound annual growth rate (CAGR) of roughly 4-6% (as per IQVIA and primary industry reports [1]). The intranasal corticosteroids (INSs) segment dominates the allergy treatment market owing to their efficacy, safety, and ease of administration.

Key Competitors

OMNARIS’s principal competitors include Flonase (fluticasone propionate), Nasacort (triamcinolone acetonide), Rhinocort (budesonide), and newer entrants like Dymista (azelastine + fluticasone). Despite strong competition, OMNARIS differentiates itself through unique formulation advantages, dosing convenience, and positioning within specialized therapy guidelines.

Target Patient Population

Approximately 20-30% of the global population suffers from allergic rhinitis, representing a substantial market. OMNARIS’s approval for both seasonal and perennial allergies broadens its potential user base, especially among patients with nasal polyps and those unresponsive to other treatments.

Market Dynamics

Regulatory Landscape and Approvals

Having received FDA approval in 2014, OMNARIS benefitted from regulatory clarity and positioning within established treatment protocols. In 2020, its approval for nasal polyps expanded its medical utility, opening avenues into the chronic sinusitis segment. Regulatory endorsements enhance market confidence but necessitate ongoing post-market surveillance to maintain credibility.

Physician Prescribing Trends

Physicians favor intranasal corticosteroids due to their high efficacy and minimal systemic absorption. OMNARIS’s favorable safety profile, particularly its low systemic bioavailability, aligns with clinical preference for corticosteroids with reduced adverse effects. Prescribing is further influenced by formulary placements, insurance reimbursements, and patient compliance factors.

Market Penetration Strategies

Sunovion leverages direct-to-physician marketing, clinical education, and partnerships with healthcare providers to expand OMNARIS’s footprint. Emphasis on nasal polyps and chronic sinusitis also aligns marketing efforts towards ENT specialists, a niche with less competition and high unmet needs.

Pricing and Reimbursement Dynamics

As a prescription drug, OMNARIS is subject to variable reimbursement landscapes across regions. In the U.S., the drug’s premium positioning is justified through efficacy data and favorable safety profile, though price sensitivity impacts adoption among cost-conscious payers and patients. Globally, reimbursement policies exert similar influence, with some markets experiencing delays due to regulatory and formulary barriers.

Emerging Trends & Market Drivers

• Rise of Personalized Medicine: Biomarker-driven patient selection could enhance treatment outcomes, indirectly influencing OMNARIS’s adoption.
• Off-Label Usage and New Indications: Expansion into upper respiratory conditions and nasal polyps fosters growth.
• Patient Preference and Compliance: Once-daily dosing and minimal side effects make OMNARIS appealing.

Financial Trajectory and Revenue Projections

Historical Financial Performance

Since its launch, OMNARIS has contributed steadily to Sunovion’s top-line revenues, with global sales reaching approximately USD 200-300 million annually by 2021 [2]. Sales growth has been driven by expanding indications, increased patient uptake, and clinician familiarity.

Factors Influencing Future Revenue

• Pipeline and Indication Expansion: Pending or approved additional indications, such as nasal polyps, could augment revenue streams.
• Market Penetration in Emerging Economies: Growing healthcare infrastructure and allergy prevalence in emerging markets offer substantial growth potential.
• Competitive Challenges: Patent life, biosimilar threats, and newer formulations could impact market share.
• Pricing Dynamics: Reimbursement pressures, especially in cost-sensitive markets, may influence margins.
• Regulatory Approvals and Variability: Navigating approval pathways in diverse jurisdictions remains critical.

Forecast and Growth Estimates

Analysts project a Compound Annual Growth Rate of 3-5% over the next five years for OMNARIS, assuming successful expansion into new indications and markets. Global sales could approach USD 400 million by 2027, contingent on sustained market penetration, competitive landscape, and regulatory factors.

Challenges and Opportunities

Challenges

• Intense Competition: Fluctuations in market share owing to patent expirations or biosimilar entries.
• Pricing Pressures: Increasing emphasis on cost-containment may limit pricing power.
• Regulatory Variability: Different approval timelines and requirements across regions.
• Patient Compliance: Adherence issues, particularly with nasal sprays, could impact clinical outcomes and sales.

Opportunities

• Expansion of Indications: Chronic rhinosinusitis with nasal polyps (CRSwNP) and pediatric applications offer growth avenues.
• Innovative Delivery Systems: Development of integrated, user-friendly inhalers or spray devices.
• Market Penetration in the Asia-Pacific Region: High allergy prevalence and expanding healthcare infrastructure.

Conclusion

OMNARIS’s market trajectory is shaped by robust clinical efficacy, expanding indications, and targeted marketing within a competitive landscape. While challenges such as pricing pressures and patent landscape remain, strategic expansion into new indications, regional markets, and innovative delivery systems position OMNARIS for continued growth. The product’s financial prospects hinge on navigating regulatory, reimbursement, and competitive dynamics effectively.

Key Takeaways

• OMNARIS is positioned as a leading intranasal corticosteroid with a growing global footprint in allergy and nasal polyposis management.
• The drug’s differentiation through safety, efficacy, and clinician-focused marketing supports steady revenue growth.
• Expansion into chronic sinusitis indications and emerging markets offers significant upside.
• Competitive pressures and pricing dynamics necessitate agile strategies to sustain profitability.
• The future outlook remains positive, provided Sunovion effectively manages regulatory, reimbursement, and clinical challenges.

FAQs

1. What distinguishes OMNARIS from other intranasal corticosteroids?
OMNARIS’s unique formulation ensures high topical efficacy with minimal systemic absorption, resulting in a favorable safety profile. Its once-daily dosing and targeted delivery also enhance patient compliance.

2. What are the key growth drivers for OMNARIS in the upcoming years?
Expansion into nasal polyposis and sinusitis, regulatory approvals in emerging markets, and development of innovative delivery devices are primary growth drivers.

3. How does competitive pressure impact OMNARIS’s market share?
The presence of established brands like Flonase and Nasacort constrains market share growth. Biosimilar entrants and new formulations could further challenge OMNARIS’s positioning.

4. What role do reimbursement policies play in OMNARIS’s financial success?
Reimbursement determines patient accessibility. Favorable insurance coverage accelerates adoption, while reimbursement hurdles can slow growth, especially in cost-sensitive markets.

5. Are there any upcoming regulatory filings or clinical trials that could influence OMNARIS’s future?
Pending filings aim to expand indications to nasal polyps and pediatric populations. Successful trial outcomes and approvals can substantially enhance the product’s revenue trajectory.

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Sources

[1] IQVIA, "Global Allergy and Respiratory Market Report," 2022.
[2] Sunovion Pharmaceuticals, Annual Report, 2021.