Ciclesonide - Generic Drug Details

What are the generic drug sources for ciclesonide and what is the scope of freedom to operate?

Ciclesonide is the generic ingredient in three branded drugs marketed by Covis and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciclesonide has fourteen patent family members in twelve countries.

There are seven drug master file entries for ciclesonide. One supplier is listed for this compound.

Summary for ciclesonide

International Patents:	14
US Patents:	1
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	77
Drug Prices:	Drug price trends for ciclesonide
What excipients (inactive ingredients) are in ciclesonide?	ciclesonide excipients list
DailyMed Link:	ciclesonide at DailyMed

See drug prices for ciclesonide

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

Constraining patent/regulatory exclusivity:

8,371,292

Dosage:

AEROSOL, METERED;INHALATION

Constraining patent/regulatory exclusivity:

8,371,292

Dosage:

AEROSOL, METERED;NASAL

Constraining patent/regulatory exclusivity:

8,371,292

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 ciclesonide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE1
Children's Mercy Hospital Kansas City	PHASE1
University of Pittsburgh	PHASE1

See all ciclesonide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ciclesonide

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for CICLESONIDE

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 ciclesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008		RX	Yes	Yes	8,371,292
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		DISCN	Yes	No	8,371,292
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008		RX	Yes	Yes	8,371,292
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes	8,371,292

Expired US Patents for ciclesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	6,036,942
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	5,482,934
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	6,120,752
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	5,775,321
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	6,120,752
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	5,775,321
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	5,775,321

EU/EMA Drug Approvals for ciclesonide

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 ciclesonide

Country	Patent Number	Title	Estimated Expiration
Croatia	P20140257
Japan	2007505829
Spain	2452691
European Patent Office	1670482	UTILISATION DE CICLESONIDE DANS LE TRAITEMENT DE MALADIES RESPIRATOIRES (USE OF CICLESONIDE FOR THE TREATMENT OF RESPIRATORY DISEASES)
Australia	2004271744	Use of ciclesonide for the treatment of respiratory diseases
Poland	1670482
World Intellectual Property Organization (WIPO)	2005025578

Market Dynamics and Financial Trajectory for Ciclesonide

Last updated: October 22, 2025

Introduction

Ciclesonide, a potent inhaled corticosteroid (ICS), is primarily indicated for asthma and allergic rhinitis. Developed by Cipla and other pharmaceutical firms, this drug has established a niche within respiratory therapeutics due to its targeted delivery and reduced systemic side effects. Examining its market dynamics and financial trajectory reveals insights into its growth prospects amid evolving respiratory disease management, regulatory factors, and competitive landscape.

Market Overview and Demand Drivers

Global Respiratory Disease Burden

The rising prevalence of asthma and allergic rhinitis globally propels demand for effective inhaled therapies. According to the Global Asthma Report 2018, approximately 339 million individuals suffer from asthma, with incidence projected to rise driven by urbanization, pollution, and aging populations [1]. Ciclesonide's efficacy in controlling airway inflammation positions it as a preferred therapeutic option, especially given its minimal systemic absorption.

Inhaled Corticosteroids Market Growth

The ICS market is experiencing robust growth, projected to attain a compound annual growth rate (CAGR) of around 4-6% over the next decade. This growth stems from increased diagnosis rates and a shift towards inhaled therapies over oral corticosteroids due to better safety profiles [2].

COVID-19 Impact

The COVID-19 pandemic highlighted the importance of respiratory medications. Notably, some studies suggested inhaled corticosteroids might mitigate virus replication or reduce asthma exacerbations in infected patients, indirectly bolstering demand for drugs like ciclesonide [3]. Additionally, hospitals ramped up outpatient respiratory treatments to manage pandemic-driven respiratory symptoms, further influencing market dynamics.

Regulatory and Patent Landscape

Regulatory Approvals

Ciclesonide achieved regulatory approval in multiple jurisdictions, including the US (via the NDA submitted by Sunovion Pharmaceuticals and authorized around 2013), European Union, and emerging markets like India. Its approval was based on clinical trials demonstrating efficacy comparable or superior to other ICS [4].

Patent Status and Generic Entry

Initially protected by patents, ciclesonide faced patent expirations in key markets around 2018-2020, allowing generic manufacturers to enter the market. This led to significant price erosion, affecting the revenue trajectories of originator companies. However, some formulations remain under patent protection or regulatory exclusivity, sustaining premium pricing in specific regions.

Competitive Dynamics

Market Competition

Ciclesonide competes primarily with other ICS drugs, such as fluticasone propionate and budesonide. Its niche advantage lies in its reduced systemic absorption and once-daily dosing, improving patient adherence. Key competitors have established entrenched market shares; thus, ciclesonide's market expansion requires differentiation and strategic positioning.

Emerging Alternatives & Combination Therapies

Combination inhalers combining ciclesonide with long-acting beta-agonists (LABAs) such as formoterol have entered markets, expanding therapeutic coverage. The trend towards combination therapies enhances treatment adherence and efficacy, but also intensifies competition.

Market Penetration and Revenue Trajectory

Economic Factors

Pricing strategies post-patent expiry have led to multi-tiered markets:

• Premium segments: where patents uphold higher prices.
• Generic markets: with significantly lower prices, especially in emerging economies.

In developed markets, the revenues declined post-patent expiry but remained buoyant in regions where patent protection persists or where generic competition is limited.

Market Penetration Strategies

Pharmaceutical companies leverage direct-to-consumer advertising, partnerships with healthcare providers, and formulary placements to sustain revenue streams. In regions with high disease prevalence, ciclesonide continues to garner prescriptions, supporting its financial trajectory.

Sales Projections

Sales estimates suggest a moderate recovery or stabilization post-patent expiry, buoyed by formulations with enhanced delivery mechanisms and combination options. For instance, in India—a significant emerging market—ciclesonide's inclusion in government formularies and patient affordability initiatives influences sales volumes.

Research and Development Insights

Ongoing clinical trials explore new indications, such as chronic obstructive pulmonary disease (COPD) and nasal influenza prevention, expanding ciclesonide's market potential. A promising development involves combination therapies in intranasal formulations for allergic rhinitis, broadening its therapeutic scope.

Pharmaceutical Investment Outlook

Investors evaluating ciclesonide should consider:

• Patent protections and impending expirations.
• Regional regulatory landscapes impacting generic entry.
• Competitive positioning against established ICS.
• Market growth driven by respiratory disease epidemiology.
• Potential new indications from ongoing research.

In aggregate, while patent expiries caused revenue compression in mature markets, strategic diversification and innovation could sustain or grow revenues.

Regulatory and Reimbursement Trends

Healthcare policies influencing reimbursement rates significantly impact ciclesonide's market access. Governments increasingly favor cost-effective therapies, favoring generics, which puts pressure on the originator's margins but expands volume sales.

Key Challenges and Opportunities

Challenges

• Patent cliffs constrict profitability in core markets.
• Intense competition from generics and fixed-dose combinations.
• Pricing pressures amid healthcare budget constraints in emerging markets.

Opportunities

• Development of novel formulations improving bioavailability.
• Expansion into new indications or delivery devices.
• Strategic alliances for combination therapies.

Conclusion

The financial trajectory of ciclesonide hinges on patent management, regional market conditions, and competitive innovation. While facing typical challenges associated with generic competition post-patent expiration, strategic focus on R&D, differentiated formulations, and expanding indications can stabilize or enhance its market position. The rising global respiratory disease burden ensures enduring demand, making ciclesonide a noteworthy asset within the ICS landscape.

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Key Takeaways

• Market growth is driven by rising respiratory disease prevalence and improved diagnosis, positioning ciclesonide favorably despite patent expirations.
• Patent protections in key regions sustain premium pricing but face erosion from generic entrants, impacting revenues.
• Competition from established ICS and combination inhalers necessitates innovation and strategic differentiation for sustained market share.
• New formulation development and expanded indications present growth avenues, especially in emerging markets.
• Regulatory and reimbursement policies critically influence market access, emphasizing the importance of strategic regional positioning.

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FAQs

1. What are the main factors influencing ciclesonide’s market performance?
   The prevalence of respiratory diseases, patent status, competitive landscape, regulatory approvals, and reimbursement policies collectively shape its market performance.

2. How has patent expiry affected ciclesonide’s revenue?
   Patent expiration led to increased generic competition, resulting in significant price erosion and revenue decline in mature markets. However, some formulations remain protected, sustaining revenues.

3. What are potential growth opportunities for ciclesonide?
   Opportunities include developing new delivery systems, exploring additional indications like COPD, expanding into emerging markets, and forming strategic partnerships for combination therapies.

4. How does the competitive landscape influence ciclesonide’s market share?
   Established treatments like fluticasone and budesonide dominate due to brand loyalty and infrastructure; ciclesonide must offer unique benefits such as better tolerability and adherence to grow its share.

5. What role does regulatory environment play in ciclesonide’s market trajectory?
   Favorable approvals and reimbursement frameworks facilitate market access, while regulatory hurdles or delays can impede growth, making compliance and strategic navigation essential.

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Sources
[1] Global Asthma Report 2018. Asthma UK.
[2] MarketsandMarkets. Inhalation Drugs Market Forecasts.
[3] Rokho Kim et al., “Inhaled corticosteroids and COVID-19,” Nature Medicine, 2020.
[4] U.S. Food & Drug Administration. Ciclesonide NDA Approvals.