Ciclesonide - Generic Drug Details

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What are the generic drug sources for ciclesonide and what is the scope of patent protection?

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 fifteen patent family members in thirteen countries.

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

Summary for ciclesonide

International Patents:	15
US Patents:	1
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	76
Patent Applications:	7,192
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
Centre Muraz	Phase 2/Phase 3
PACCI Program	Phase 2/Phase 3

See all ciclesonide clinical trials

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	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	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	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ciclesonide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ciclesonide

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Country	Patent Number	Title	Estimated Expiration
Denmark	1670482		See Plans and Pricing
Japan	2007505829		See Plans and Pricing
Slovenia	1670482		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.