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Details for Generic Name: flunisolide

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Flunisolide is the generic ingredient in five branded drugs marketed by Roche Palo, Meda Pharms Inc, Apotex Inc, Bausch And Lomb, Hi Tech Pharma Co, Ivax Res, and Teva Branded Pharm, and is included in seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twelve patent family members in eleven countries.

There are twelve drug master file entries for flunisolide. One supplier is listed for this compound.

Summary for Generic Name: flunisolide

Drug Master File Entries: see list12
Suppliers: see list1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: flunisolide

Clinical Trials for: flunisolide

Flunisolide HFA in Children With Small Airway Disease
Status: Not yet recruiting Condition: Asthma

Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
Status: Completed Condition: Rhinitis, Allergic, Perennial

Mentored Patient-Oriented Research Career Development Award
Status: Recruiting Condition: Asthma; Distal Lung Inflammation

Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Status: Completed Condition: Asthma

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb
SPRAY, METERED;NASAL074805-001Feb 20, 2002RXYes<disabled><disabled>
Meda Pharms Inc
AEROSOL, METERED;INHALATION021247-001Jan 27, 2006RXYes<disabled><disabled>
Roche Palo
AEROSOL, METERED;INHALATION018340-001Aug 17, 1984DISCNNo<disabled><disabled>
Apotex Inc
SPRAY, METERED;NASAL077436-001Aug 9, 2007RXYes<disabled><disabled>
Hi Tech Pharma Co
SPRAY, METERED;NASAL077704-001Aug 3, 2006RXNo<disabled><disabled>
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International Patent Family for Ingredient: flunisolide

Country Document Number Publication Date
JapanH09506896Jul 08, 1997
Canada2178473Jun 29, 1995
Australia1098695Jul 10, 1995
Spain2145254Jul 01, 2000
Germany69424181Oct 19, 2000
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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