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	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes	8,371,292
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	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

Expired US Patents for ciclesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	6,036,942
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	6,006,745
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	5,683,677
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	5,482,934
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	5,482,934
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	6,120,752

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
Slovenia	1670482
Japan	5618452
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
Croatia	P20140257
Denmark	1670482

Market Dynamics and Financial Trajectory for Ciclesonide

Last updated: February 19, 2026

Ciclesonide, an inhaled corticosteroid, targets asthma and allergic rhinitis. Its commercialization and development landscape reflect shifts in regulatory approvals, market competition, and changing prescribing trends.

Regulatory Approvals and Market Entry

Ciclesonide was initially approved by the FDA in 2006 for asthma under the brand name Alvesco, and later for allergic rhinitis. Its approval status in other regions varies, influencing global market penetration.

Market Size and Growth Drivers

The global inhaled corticosteroids market was valued at approximately USD 8 billion in 2022, with a projected compound annual growth rate (CAGR) of around 4% through 2030. Ciclesonide's market share within this segment remains modest, primarily due to competition from agents like fluticasone and budesonide.

Growth drivers include:

• Increasing prevalence of asthma and allergic rhinitis, especially in North America and Asia-Pacific.
• Rising diagnosis rates and better awareness.
• Expanded label indications in some markets, including pediatric use.

Competitive Landscape

Major competitors include:

• Fluticasone propionate (GlaxoSmithKline)
• Budesonide (AstraZeneca)
• Mometasone (Merck)

Ciclesonide’s advantages:

• Once-daily dosing.
• Lower systemic bioavailability, implying fewer side effects.
• Approved for pediatric populations aged 6 and above.

However, it faces challenges:

• Market dominance by established brands.
• Patent expiration and generic entrants starting around 2018.
• Limited pipeline expansion, as some competitors developed combination inhalers.

Patent and Regulatory Outlook

Patent protection for Alvesco expired in the U.S. in 2018, leading to increased generic competition. Despite this, brand sales persist due to physician familiarity and formulary preferences.

Regulatory pipelines:

• No recent major filings or approvals specifically expanding ciclesonide indications.
• Some regions contemplating approval for nasal spray formulations for allergic rhinitis.

Financial Performance and Trends

Global sales of Alvesco peaked at approximately USD 200 million in 2014. Following patent expiration:

Year	Sales (USD millions)	Comments
2014	200	Peak for branded product
2018	60	Decline due to generics
2022	40	Stabilization, some niche use

Sales decline reflects generic erosion, though steady revenue persists through established markets.

Outlook and Potential Growth Areas

Future growth hinges on:

• Expansion into emerging markets with rising asthma prevalence.
• Development of combination inhalers with other agents.
• Focus on pediatric and nasal applications.

Despite limited pipeline activity, some pharmaceutical companies explore reformulations or novel delivery methods to sustain sales.

Investment and R&D Considerations

Investors should weigh:

• Diminished revenues in mature markets due to patent loss.
• Opportunities in regional expansion and formulation innovation.
• Competitive pressure from newer biologic treatments for severe asthma.

R&D investment is unlikely to target ciclesonide directly, given patent expirations and modest pipeline activity. Instead, focus shifts to combination inhalers and nasal spray variants.

Key Takeaways

• Market growth driven by rising respiratory disease prevalence; however, ciclesonide faces significant generic competition.
• Sales peaked pre-2018; declines correlate with patent expiration.
• Limited pipeline activity suggests near-term prospects rely on market share retention rather than innovation.
• Expansion into emerging markets and new delivery forms may offer incremental growth.
• Competitive landscape remains dominated by established drugs with broader portfolios.

FAQs

1. How has patent expiry affected ciclesonide’s market?
Patent expiry in 2018 led to generic entrants, causing sales declines from approximately USD 200 million in 2014 to about USD 40 million in 2022.

2. What are the main competitors to ciclesonide?
Fluticasone propionate, budesonide, and mometasone dominate the inhaled corticosteroid segment.

3. Are there new formulations or indications under development?
There are no substantial new approvals; some companies explore nasal spray formulations, but no major pipeline developments have emerged.

4. Which regions show the most potential for growth?
Emerging markets in Asia-Pacific and Latin America show potential due to increasing disease prevalence and lower market saturation.

5. What factors could restore growth for ciclesonide?
Market expansion, reformulation efforts, and inclusion in combination therapies may provide incremental growth opportunities.

---

References:

[1] Grand View Research. (2023). Inhaled Corticosteroids Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2018). Alvesco (ciclesonide) Prescribing Information.
[3] MarketWatch. (2022). Inhaled Corticosteroids Market Analysis and Forecasts.
[4] Statista. (2023). Respiratory Disease Prevalence and Market Trends.
[5] EMA. (2019). Summary of Product Characteristics for Alvesco.