Ciclesonide - Generic Drug Details
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What are the generic drug sources for ciclesonide and what is the scope of patent protection?
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 fifteen patent family members in thirteen countries.
There are seven drug master file entries for ciclesonide. One supplier is listed for this compound.
Summary for ciclesonide
International Patents: | 15 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 76 |
Patent Applications: | 7,192 |
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 |
Centre Muraz | Phase 2/Phase 3 |
PACCI Program | Phase 2/Phase 3 |
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 | 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 | 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 | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ciclesonide
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim Vetmedica GmbH | Aservo EquiHaler | ciclesonide | EMEA/V/C/004991 For the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction – (RAO), Summer Pasture Associated Recurrent Airway Obstruction – (SPA-RAO)). |
Authorised | no | no | no | 2020-01-28 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ciclesonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1670482 | See Plans and Pricing | |
Japan | 2007505829 | See Plans and Pricing | |
Slovenia | 1670482 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |