Details for New Drug Application (NDA): 202129
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NDA 202129 describes ZETONNA, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ZETONNA profile page.
The generic ingredient in ZETONNA is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.
The generic ingredient in ZETONNA is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.
Summary for 202129
| Tradename: | ZETONNA |
| Applicant: | Covis |
| Ingredient: | ciclesonide |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202129
Generic Entry Date for 202129*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, 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.
Suppliers and Packaging for NDA: 202129
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129 | NDA | Covis Pharma US, Inc | 70515-737 | 70515-737-60 | 1 CANISTER in 1 CARTON (70515-737-60) / 60 AEROSOL, METERED in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | AEROSOL, METERED;NASAL | Strength | 0.037MG/INH | ||||
| Approval Date: | Jan 20, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 1, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR TREATING A RESPIRATORY DISEASE IN A CHILD | ||||||||
Expired US Patents for NDA 202129
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | ⤷ Subscribe | ⤷ Subscribe |
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