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Ciclesonide - Generic Drug Details

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Ciclesonide is the generic ingredient in three branded drugs marketed by Takeda Gmbh and is included in three NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and thirty-nine patent family members in fifty-one countries.

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

Summary for Generic Name: ciclesonide

Tradenames:3
Patents:10
Applicants:1
NDAs:3
Drug Master File Entries: see list7
Suppliers / Packaging: see list3
Therapeutic Class:Respiratory Tract Agents
Drug Prices:see low prices

Clinical Trials for: ciclesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYes8,371,292Feb 1, 2028
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 2012RXYes5,482,934Oct 24, 2017YY
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 2012RXYes6,264,923May 13, 2018Y
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Expired Orange Book Patents for Generic Ingredient: ciclesonide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 20085,683,677<disabled>
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 20125,775,321<disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 20085,605,674<disabled>
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Non-Orange Book Patents for Generic Ingredient: ciclesonide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,036,942 Seal configuration for aerosol canister<disabled in preview>
5,290,539 Device for delivering an aerosol<disabled in preview>
6,030,682 Container for aerosol formulation<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ciclesonide

Country Document Number Estimated Expiration
Canada2290521<disabled in preview>
Israel132738<disabled in preview>
New Zealand500874<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CICLESONIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2005006Lithuania<disabled>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
2005 00036Denmark<disabled>
C022/2005Ireland<disabled>SPC022/2005, 20060612, EXPIRES: 20190415
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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 verifification 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.

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