Details for New Drug Application (NDA): 021658
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NDA 021658 describes ALVESCO, 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 ALVESCO profile page.
The generic ingredient in ALVESCO 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 ALVESCO 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 021658
| Tradename: | ALVESCO |
| Applicant: | Covis |
| Ingredient: | ciclesonide |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021658
*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: 021658
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658 | NDA | Covis Pharma US, Inc | 70515-711 | 70515-711-01 | 1 INHALER in 1 CARTON (70515-711-01) / 60 AEROSOL, METERED in 1 INHALER |
| ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658 | NDA | Covis Pharma US, Inc | 70515-711 | 70515-711-02 | 1 INHALER in 1 CARTON (70515-711-02) / 60 AEROSOL, METERED in 1 INHALER |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.08MG/INH | ||||
| Approval Date: | Jan 10, 2008 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 1, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.16MG/INH | ||||
| Approval Date: | Jan 10, 2008 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 1, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD | ||||||||
Expired US Patents for NDA 021658
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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