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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-eight 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

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
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYes6,006,745<disabled>Y <disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYes8,371,292<disabled> <disabled>
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYes8,383,611<disabled>Y <disabled>
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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;INHALATION021658-002Jan 10, 20085,695,743<disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 20085,683,677<disabled>
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 20125,683,677<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
Brazil0014878<disabled in preview>
Luxembourg88001<disabled in preview>
Czech Republic9904124<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
2005 00036Denmark<disabled>
2005006,C0983058Lithuania<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
C022/2005Ireland<disabled>SPC022/2005, 20060612, EXPIRES: 20190415
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