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Serving 500+ biopharmaceutical companies globally:

Medtronic
Harvard Business School
Cantor Fitzgerald
Colorcon
Johnson and Johnson
Dow
US Army
Fish and Richardson
Teva
Federal Trade Commission

Generated: August 18, 2017

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Ciclesonide - Generic Drug Details

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What are the generic sources for ciclesonide and what is the scope of ciclesonide patent protection?

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

Ciclesonide has two hundred and twenty-nine patent family members in fifty-two countries.

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

Summary for Generic Name: ciclesonide

Tradenames:3
Patents:9
Applicants:1
NDAs:3
Drug Master File Entries: see list7
Suppliers / Packagers: see list2
Bulk Api Vendors: see list31
Clinical Trials: see list67
Patent Applications: see list5,718
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ciclesonide at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ciclesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 2008► Subscribe► Subscribe
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 2012► Subscribe► Subscribe
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 2008► Subscribe► Subscribe
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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
5,290,539 Device for delivering an aerosol► Subscribe
6,030,682 Container for aerosol formulation► Subscribe
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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
Denmark1670482► Subscribe
Canada2538419► Subscribe
Czech Republic9904124► Subscribe
Luxembourg88001► Subscribe
Mexico9102764► Subscribe
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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► SubscribePRODUCT 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► SubscribeSPC022/2005, 20060612, EXPIRES: 20190415
2005 00036Denmark► Subscribe
2005006,C0983058Lithuania► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
AstraZeneca
Cipla
Healthtrust
Covington
Medtronic
Colorcon
McKesson
Cantor Fitzgerald
Citi

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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