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Last Updated: May 25, 2022

ZETONNA Drug Patent Profile


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Which patents cover Zetonna, and what generic alternatives are available?

Zetonna is a drug marketed by Covis and is included in one NDA. There is one patent protecting this drug.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in ZETONNA is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.

DrugPatentWatch® Generic Entry Outlook for Zetonna

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZETONNA
Drug patent expirations by year for ZETONNA
Drug Prices for ZETONNA

See drug prices for ZETONNA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZETONNA
Generic Entry Date for ZETONNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, 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 ZETONNA

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

SponsorPhase
SunovionPhase 4

See all ZETONNA clinical trials

US Patents and Regulatory Information for ZETONNA

ZETONNA is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZETONNA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZETONNA

Use of ciclesonide for the treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR TREATING A RESPIRATORY DISEASE IN A CHILD

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
>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 ZETONNA

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 ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 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 ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 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 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 ZETONNA

When does loss-of-exclusivity occur for ZETONNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04271744
Estimated Expiration: See Plans and Pricing

Canada

Patent: 38419
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0140257
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17371
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 70482
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 70482
Estimated Expiration: See Plans and Pricing

Japan

Patent: 18452
Estimated Expiration: See Plans and Pricing

Patent: 07505829
Estimated Expiration: See Plans and Pricing

Patent: 12197306
Estimated Expiration: See Plans and Pricing

Poland

Patent: 70482
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 70482
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 70482
Estimated Expiration: See Plans and Pricing

Spain

Patent: 52691
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZETONNA around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 002381 МЕДИЦИНСКИЕ АЭРОЗОЛЬНЫЕ ПРЕПАРАТЫ (MEDICAL AEROSOL PRODUCTS) See Plans and Pricing
Belgium 1005876 NIEUWE PREGNA-1,4-DIEEN-3,20-DION-16-17-ACETAAL-21 ESTERS, WERKWIJZE VOOR EEN BEREIDING, PREPARAAT EN WERKWIJZE VOOR DE BEHANDELING VAN ONTSTEKINGSCONDITIES. See Plans and Pricing
Chile 2004001325 See Plans and Pricing
Eurasian Patent Organization 199900991 See Plans and Pricing
Luxembourg 88001 See Plans and Pricing
Denmark 1670482 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZETONNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0983058 PA2005006,C0983058 Lithuania See Plans and Pricing PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
0983058 CA 2005 00036 Denmark See Plans and Pricing
0983058 SPC022/2005 Ireland See Plans and Pricing SPC022/2005, 20060612, EXPIRES: 20190415
0983058 PA2005006 Lithuania See Plans and Pricing PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.