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Last Updated: July 15, 2024

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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the ciclesonide profile page.
Summary for 021658
Tradename:ALVESCO
Applicant:Covis
Ingredient:ciclesonide
Patents:1
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021658
Generic Entry Date for 021658*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION

*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 Sixarp, LLC 59368-100 59368-100-01 1 INHALER in 1 CARTON (59368-100-01) / 60 AEROSOL, METERED in 1 INHALER
ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658 NDA Sixarp, LLC 59368-101 59368-101-01 1 INHALER in 1 CARTON (59368-101-01) / 60 AEROSOL, METERED in 1 INHALER

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.08MG/INH
Approval Date:Jan 10, 2008TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 1, 2028Product 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:RXDosage:AEROSOL, METERED;INHALATIONStrength0.16MG/INH
Approval Date:Jan 10, 2008TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 1, 2028Product 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 021658-002 Jan 10, 2008 ⤷  Sign Up ⤷  Sign Up
Covis ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 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 021658-002 Jan 10, 2008 ⤷  Sign Up ⤷  Sign Up
Covis ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.