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Last Updated: January 27, 2023

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
Drug Prices for ciclesonide

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Recent Clinical Trials for ciclesonide

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

SponsorPhase
Hvidovre University HospitalPhase 4
Centre MurazPhase 2/Phase 3
PACCI ProgramPhase 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

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

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

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

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Serving leading biopharmaceutical companies globally:

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Medtronic
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Mallinckrodt

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