Ciclesonide - Generic Drug Details
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What are the generic drug sources for ciclesonide and what is the scope of freedom to operate?
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: | 54 |
Clinical Trials: | 76 |
Patent Applications: | 7,035 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ciclesonide |
What excipients (inactive ingredients) are in ciclesonide? | ciclesonide excipients list |
DailyMed Link: | ciclesonide at DailyMed |
Recent Clinical Trials for ciclesonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hvidovre University Hospital | Phase 4 |
ANRS, Emerging Infectious Diseases | Phase 2/Phase 3 |
Centre Muraz | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ciclesonide
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
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 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | See Plans and Pricing | See Plans and Pricing |
Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | See Plans and Pricing | See Plans and Pricing |
Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | See Plans and Pricing | See Plans and Pricing |
Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ciclesonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2005025578 | See Plans and Pricing | |
Poland | 1670482 | See Plans and Pricing | |
Canada | 2538419 | UTILISATION DE CICLESONIDE DANS LE TRAITEMENT DE MALADIES RESPIRATOIRES (USE OF CICLESONIDE FOR THE TREATMENT OF RESPIRATORY DISEASES) | See Plans and Pricing |
Cyprus | 1117371 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |