CICLESONIDE - Generic Drug Details
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What are the generic 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 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: | 66 |
Clinical Trials: | 76 |
Patent Applications: | 6,305 |
Drug Prices: | Drug price trends for CICLESONIDE |
What excipients (inactive ingredients) are in CICLESONIDE? | CICLESONIDE excipients list |
DailyMed Link: | CICLESONIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CICLESONIDE
Generic Entry Dates for CICLESONIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION |
Generic Entry Dates for CICLESONIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;NASAL |
Generic Entry Dates for CICLESONIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;NASAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for CICLESONIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hvidovre University Hospital | Phase 4 |
Institut National de la Santé Et de la Recherche Médicale, France | Phase 2/Phase 3 |
Alliance for International Medical Action | 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 | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Slovenia | 1670482 | ⤷ Sign Up | |
Spain | 2452691 | ⤷ Sign Up | |
Australia | 2004271744 | Use of ciclesonide for the treatment of respiratory diseases | ⤷ Sign Up |
Japan | 5618452 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2005025578 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |