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Last Updated: March 19, 2024

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 fourteen patent family members in twelve countries.

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

Summary for ciclesonide
Drug Prices for ciclesonide

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ciclesonide
Generic Entry Dates for ciclesonide*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION
Generic Entry Dates for ciclesonide*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;NASAL
Generic Entry Dates for ciclesonide*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Hvidovre University HospitalPhase 4
PACCI ProgramPhase 2/Phase 3
Barcelona Institute for Global HealthPhase 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Covis ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Covis ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008 ⤷  Try a Trial ⤷  Try a Trial
Covis ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 ⤷  Try a Trial ⤷  Try a Trial
Covis OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
Covis ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008 ⤷  Try a Trial ⤷  Try a Trial
Covis ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 ⤷  Try a Trial ⤷  Try a Trial
Covis ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for ciclesonide

Country Patent Number Title Estimated Expiration
Slovenia 1670482 ⤷  Try a Trial
European Patent Office 1670482 UTILISATION DE CICLESONIDE DANS LE TRAITEMENT DE MALADIES RESPIRATOIRES (USE OF CICLESONIDE FOR THE TREATMENT OF RESPIRATORY DISEASES) ⤷  Try a Trial
Spain 2452691 ⤷  Try a Trial
Japan 2012197306 USE OF CICLESONIDE FOR TREATMENT OF RESPIRATORY DISEASE ⤷  Try a Trial
Poland 1670482 ⤷  Try a Trial
Japan 2007505829 ⤷  Try a Trial
>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.