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Details for Generic Name: ciclesonide

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

There are seven drug master file entries for ciclesonide. Three suppliers are listed for this compound.

Summary for Generic Name: ciclesonide

Tradenames:3
Patents:11
Applicants:1
NDAs:3
Drug Master File Entries: see list7
Suppliers: see list3
Therapeutic Class:Respiratory Tract Agents

Clinical Trials for: ciclesonide

Omnaris Versus Levocetirizine Phase 4 Study
Status: Completed Condition: Allergic Rhinitis

Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis
Status: Completed Condition: Perennial Allergic Rhinitis

A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
Status: Completed Condition: Perennial Allergic Rhinitis

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
Status: Completed Condition: Seasonal Allergic Rhinitis

Ciclesonide for the Treatment of Airway Hyperresponsiveness
Status: Completed Condition: Asthma

Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia
Status: Recruiting Condition: Seasonal Allergic Rhinitis

To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
Status: Completed Condition: Rhinitis, Allergic, Perennial; Hay Fever

Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)
Status: Completed Condition: Rhinitis, Allergic, Seasonal

Effect of Ciclesonide on Exercise Induced Bronchoconstriction
Status: Completed Condition: Asthma

A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Status: Completed Condition: Perennial Allergic Rhinitis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 2012RXYes6,006,745<disabled>Y<disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYes6,006,745<disabled>Y<disabled>
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYes7,235,247<disabled>Y<disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXNo5,775,321<disabled>Y<disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXNo8,371,292<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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