Ciclesonide - Generic Drug Details

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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:	54
Clinical Trials:	76
Patent Applications:	7,035
Formulation / Manufacturing:	see details
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

Recent Clinical Trials for ciclesonide

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

Sponsor	Phase
Hvidovre University Hospital	Phase 4
ANRS, Emerging Infectious Diseases	Phase 2/Phase 3
Centre Muraz	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

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Glossary

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

Expired US Patents for ciclesonide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	See Plans and Pricing	See Plans and Pricing
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	See Plans and Pricing	See Plans and Pricing
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	See Plans and Pricing	See Plans and Pricing
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ciclesonide

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005025578		See Plans and Pricing
Poland	1670482		See Plans and Pricing
Canada	2538419	UTILISATION DE CICLESONIDE DANS LE TRAITEMENT DE MALADIES RESPIRATOIRES (USE OF CICLESONIDE FOR THE TREATMENT OF RESPIRATORY DISEASES)	See Plans and Pricing
Cyprus	1117371		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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