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:	76
Patent Applications:	6,305
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

Dosage:

AEROSOL, METERED;INHALATION

Dosage:

AEROSOL, METERED;NASAL

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
Hvidovre University Hospital	Phase 4
Institut National de la Santé Et de la Recherche Médicale, France	Phase 2/Phase 3
Alliance for International Medical Action	Phase 2/Phase 3

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	021658-003	Jan 10, 2008		RX	Yes	Yes
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		DISCN	Yes	No
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008		RX	Yes	Yes
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes

Expired US Patents for ciclesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008

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/004991 For 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
Denmark	1670482
Croatia	P20140257
Canada	2538419	UTILISATION DE CICLESONIDE DANS LE TRAITEMENT DE MALADIES RESPIRATOIRES (USE OF CICLESONIDE FOR THE TREATMENT OF RESPIRATORY DISEASES)
Poland	1670482
Japan	2007505829
Australia	2004271744	Use of ciclesonide for the treatment of respiratory diseases

Ciclesonide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ciclesonide

Introduction to Ciclesonide

Ciclesonide, marketed under the brand name Alvesco, is an inhaled corticosteroid used primarily to prevent the symptoms of asthma and manage other respiratory conditions such as allergic rhinitis. It works by reducing inflammation in the lungs, thereby decreasing the severity and frequency of asthma attacks[5].

Global Market Size and Growth

The global ciclesonide market has been experiencing significant growth in recent years. As of 2018, the market size was estimated to be around $565.4 million, with a projected compound annual growth rate (CAGR) of 1.9% over the forecast period from 2018 to 2026[1].

However, more recent estimates suggest a more robust growth trajectory. The market is now projected to grow at a CAGR of approximately 7% over the next decade, driven by increasing awareness of respiratory health, advancements in inhaled corticosteroid formulations, and a growing demand for effective treatment options[4].

Drivers of Market Growth

Rising Prevalence of Respiratory Diseases

The global prevalence of asthma and allergic rhinitis is on the rise, particularly in low- and middle-income countries. According to the Global Asthma Report, asthma affects around 339 million people worldwide and causes approximately 1,000 deaths daily. This increasing prevalence is a major driver of the ciclesonide market[1].

Advancements in Drug Formulations

Recent innovations in ciclesonide formulations and delivery devices have enhanced the drug's delivery efficiency and patient usability. These advancements are expected to drive further growth by providing more effective and user-friendly treatment options[4].

Increased Awareness and Diagnosis

Enhanced diagnostic tools and greater public awareness have led to earlier detection and treatment of respiratory diseases. This trend has positively impacted the demand for ciclesonide and other respiratory medications[4].

Strategic Partnerships and Collaborations

The ciclesonide market has seen a rise in strategic partnerships and collaborations between pharmaceutical companies. These alliances aim to accelerate the development of new formulations and expand market reach. Such collaborations are instrumental in bringing innovative ciclesonide products to market and meeting the growing demand for effective respiratory treatments[4].

Market Challenges

Despite the positive outlook, the ciclesonide market faces certain challenges:

Regulatory Hurdles

Navigating regulatory requirements can be complex and time-consuming, potentially slowing down the introduction of new products and formulations[4].

Market Competition

The market is becoming increasingly competitive due to the entry of new players and the expansion of existing ones through acquisitions and mergers. This competition requires companies to innovate continuously to maintain their market position[4].

Financial Trajectory

The financial trajectory of the ciclesonide market is promising, with several key indicators:

Revenue Projections

With a projected CAGR of 7%, the market is expected to see significant revenue growth over the next decade. This growth will be driven by the increasing demand for effective respiratory treatments and the introduction of new and improved formulations[4].

Investment Opportunities

For investors and businesses, the growing ciclesonide market presents significant opportunities. The emphasis on personalized medicine, ongoing advancements in drug formulations, and increasing global awareness of respiratory health are expected to fuel market growth and provide lucrative investment opportunities[4].

Clinical Trials and Emerging Uses

Ciclesonide is also being explored for its potential in treating other conditions beyond asthma and allergic rhinitis. For example, clinical trials are underway to investigate its use in COVID-19 patients to reduce inflammation and prevent severe respiratory complications. These studies aim to determine whether early treatment with inhaled corticosteroids like ciclesonide can reduce symptoms and hospitalizations[2].

Patient and Market Impact

The impact of ciclesonide on patients is significant:

Symptom Management

Ciclesonide helps prevent asthma attacks and reduces their severity when used regularly. It is not intended for acute asthma attacks but is crucial for long-term management[5].

Quality of Life

By effectively managing respiratory symptoms, ciclesonide improves the quality of life for patients with asthma and other respiratory conditions. Early detection and treatment, facilitated by enhanced diagnostic tools and public awareness, further contribute to better patient outcomes[4].

Key Takeaways

• The global ciclesonide market is projected to grow at a CAGR of approximately 7% over the next decade.
• The market is driven by the rising prevalence of respiratory diseases, advancements in drug formulations, and increased awareness and diagnosis.
• Strategic partnerships and collaborations are key to accelerating the development of new formulations and expanding market reach.
• Despite challenges like regulatory hurdles and market competition, the market is well-positioned for sustained growth.
• Ciclesonide is being explored for its potential in treating COVID-19 and other conditions, further expanding its market potential.

FAQs

1. What is ciclesonide used for? Ciclesonide is used to help prevent the symptoms of asthma and manage other respiratory conditions such as allergic rhinitis. It works by reducing inflammation in the lungs[5].

2. What is the current market size and growth rate of the ciclesonide market? As of 2018, the market size was estimated to be around $565.4 million, with a projected CAGR of 1.9%. However, recent estimates suggest a CAGR of approximately 7% over the next decade[1][4].

3. What are the key drivers of the ciclesonide market growth? The key drivers include the rising prevalence of respiratory diseases, advancements in drug formulations, and increased awareness and diagnosis of respiratory conditions[4].

4. Are there any ongoing clinical trials for ciclesonide? Yes, ciclesonide is being investigated in clinical trials for its potential use in treating COVID-19 patients to reduce inflammation and prevent severe respiratory complications[2].

5. What are the potential side effects of ciclesonide? Ciclesonide can cause a range of side effects, including infections, sores in the mouth or throat, and growth suppression in children. It may also increase the risk of infections such as chickenpox or measles[5].

Cited Sources:

1. Coherent Market Insights - Ciclesonide Market Size and Trends.
2. Wake Forest University School of Medicine - COVID-19 Research.
3. Pharmaceuticals.gov.in - An Analysis on leveraging the patent cliff with drug sales worth USD.
4. Market Research Intellect - Ciclesonide Market Surge: A New Era in Respiratory Treatment.
5. Mayo Clinic - Ciclesonide (inhalation route).