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Ciclesonide - Generic Drug Details
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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 list | 7 |
| Suppliers / Packaging: see list | 3 |
| 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;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | 8,371,292 | Feb 1, 2028 | ||||||||||||||||||||
Takeda Gmbh | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | RX | Yes | 5,482,934 | Oct 24, 2017 | Y | Y | ||||||||||||||||||
Takeda Gmbh | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | RX | Yes | 6,264,923 | May 13, 2018 | Y | |||||||||||||||||||
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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;INHALATION | 021658-003 | Jan 10, 2008 | 5,683,677 | <disabled> | ||||||||||||||||||||||
Takeda Gmbh | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | 5,775,321 | <disabled> | ||||||||||||||||||||||
Takeda Gmbh | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | 5,605,674 | <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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2290521 | <disabled in preview> | |||||||||||||||||||||||||||
| Israel | 132738 | <disabled in preview> | |||||||||||||||||||||||||||
| New Zealand | 500874 | <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.
Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: CICLESONIDE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2005006 | Lithuania | <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 00036 | Denmark | <disabled> | |||||||||||||||||||||||||||
| C022/2005 | Ireland | <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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