ZETONNA Drug Patent Profile

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

Summary for ZETONNA

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	1
Patent Applications:	4,651
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZETONNA
What excipients (inactive ingredients) are in ZETONNA?	ZETONNA excipients list
DailyMed Link:	ZETONNA at DailyMed

See drug prices for ZETONNA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ZETONNA

NDA:

202129

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

Sponsor	Phase
Sunovion	Phase 4

See all ZETONNA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ZETONNA

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

US Patents and Regulatory Information for ZETONNA

ZETONNA is protected by one US patents.

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

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

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

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

Canada

Croatia

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

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)
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.
Chile	2004001325
Eurasian Patent Organization	199900991
Luxembourg	88001
Denmark	1670482

Supplementary Protection Certificates for ZETONNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0983058	PA2005006,C0983058	Lithuania		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
0983058	SPC022/2005	Ireland		SPC022/2005, 20060612, EXPIRES: 20190415
0983058	PA2005006	Lithuania		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