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Flunisolide - Generic Drug Details

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Flunisolide is the generic ingredient in five branded drugs marketed by Hi Tech Pharma Co, Bausch And Lomb, Teva Branded Pharm, Apotex Inc, Roche Palo, Meda Pharms, and Ivax Res, 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. Six suppliers are listed for this compound.

Summary for Generic Name: flunisolide

Tradenames:5
Patents:1
Applicants:7
NDAs:7
Drug Master File Entries: see list12
Suppliers / Packaging: see list6
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: flunisolide

Clinical Trials for: flunisolide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb
FLUNISOLIDE
flunisolide
SPRAY, METERED;NASAL074805-001Feb 20, 2002RXYes<disabled><disabled>
Meda Pharms
AEROSPAN HFA
flunisolide
AEROSOL, METERED;INHALATION021247-001Jan 27, 2006RXYes<disabled><disabled>
Apotex Inc
FLUNISOLIDE
flunisolide
SPRAY, METERED;NASAL077436-001Aug 9, 2007RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: flunisolide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
AEROSPAN HFA
flunisolide
AEROSOL, METERED;INHALATION021247-001Jan 27, 20065,776,433<disabled>
Teva Branded Pharm
NASAREL
flunisolide
SPRAY, METERED;NASAL020409-001Mar 8, 19954,782,047<disabled>
Teva Branded Pharm
NASAREL
flunisolide
SPRAY, METERED;NASAL020409-001Mar 8, 19954,983,595<disabled>
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Non-Orange Book Patents for Generic Ingredient: flunisolide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,980,867 Flunisolide aerosol formulations<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: flunisolide

Country Document Number Estimated Expiration
New Zealand276637<disabled in preview>
Canada2178473<disabled in preview>
JapanH09506896<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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