CICLESONIDE - Generic Drug Details

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What are the generic 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. One supplier is listed for this compound.

Summary for CICLESONIDE

International Patents:	14
US Patents:	1
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	76
Patent Applications:	6,305
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CICLESONIDE

Generic Entry Dates for CICLESONIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: AEROSOL, METERED;INHALATION
Generic Entry Dates for CICLESONIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: AEROSOL, METERED;NASAL
Generic Entry Dates for CICLESONIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Hvidovre University Hospital	Phase 4
Alliance for International Medical Action	Phase 2/Phase 3
ANRS, Emerging Infectious Diseases	Phase 2/Phase 3

See all CICLESONIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CICLESONIDE

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

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	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	⤷ Sign Up	⤷ Sign Up
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	⤷ Sign Up	⤷ Sign Up
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	⤷ Sign Up	⤷ Sign Up
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	⤷ Sign Up	⤷ Sign Up
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	⤷ Sign Up	⤷ Sign Up
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	⤷ Sign Up	⤷ Sign Up
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
>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
Spain	2452691		⤷ Sign Up
Croatia	P20140257		⤷ Sign Up
Canada	2538419	UTILISATION DE CICLESONIDE DANS LE TRAITEMENT DE MALADIES RESPIRATOIRES (USE OF CICLESONIDE FOR THE TREATMENT OF RESPIRATORY DISEASES)	⤷ Sign Up
Portugal	1670482		⤷ Sign Up
Japan	2012197306	USE OF CICLESONIDE FOR TREATMENT OF RESPIRATORY DISEASE	⤷ Sign Up
Cyprus	1117371		⤷ Sign Up
Poland	1670482		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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