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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 Pharma Bv and is included in three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ciclesonide has one hundred and seven patent family members in thirty-six countries.
There are seven drug master file entries for ciclesonide. One supplier is listed for this compound.
Summary for ciclesonide
| International Patents: | 107 |
| US Patents: | 3 |
| Tradenames: | 3 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 72 |
| Patent Applications: | 4,555 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for ciclesonide |
| DailyMed Link: | ciclesonide at DailyMed |
Recent Clinical Trials for ciclesonide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 2/Phase 3 |
| Covis Pharma S.à.r.l. | Phase 3 |
| Danderyd Hospital | Phase 2 |
Paragraph IV (Patent) Challenges for CICLESONIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OMNARIS | SPRAY, METERED;NASAL | ciclesonide | 022004 | 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 Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Covis Pharma Bv | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Covis Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Covis Pharma Bv | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Covis Pharma Bv | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Covis Pharma Bv | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | Start Trial | Start Trial |
| Covis Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | Start Trial | Start Trial |
| Covis Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | Start Trial | Start Trial |
| Covis Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | Start Trial | Start Trial |
| Covis Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | Start Trial | Start Trial |
| Covis Pharma Bv | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | Start Trial | Start Trial |
| Covis Pharma Bv | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ciclesonide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4264211 | Start Trial |
| Mexico | PA02003975 | Start Trial |
| China | 101869570 | Start Trial |
| Germany | 60017175 | Start Trial |
| Austria | 285779 | Start Trial |
| Eurasian Patent Organization | 006015 | Start Trial |
| Czech Republic | 20021238 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
