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Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021658

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NDA 021658 describes ALVESCO, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. There are three patents 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:Astrazeneca Pharms
Ingredient:ciclesonide
Patents:3
Formulation / Manufacturing:see details
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 Sunovion Pharmaceuticals Inc. 63402-711 63402-711-01 1 INHALER in 1 CARTON (63402-711-01) > 60 AEROSOL, METERED in 1 INHALER
ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658 NDA Sunovion Pharmaceuticals Inc. 63402-711 63402-711-02 1 INHALER in 1 CARTON (63402-711-02) > 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:May 13, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 13, 2018Product Flag?YSubstance Flag?Delist Request?
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
Astrazeneca Pharms ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-003 Jan 10, 2008 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms 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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