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FLO-PRED Drug Profile

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Flo-pred is a drug marketed by Taro and is included in one NDA. It is available from one supplier. There are five patents protecting this drug.

This drug has forty-four patent family members in fourteen countries.

The generic ingredient in FLO-PRED is prednisolone acetate. There are eighty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.

Summary for Tradename: FLO-PRED

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: FLO-PRED

Clinical Trials for: FLO-PRED

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo7,799,331<disabled>Y <disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-002Jan 17, 2008DISCNNo7,799,331<disabled>Y <disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo5,881,926<disabled>Y <disabled>
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Expired Patents for Tradename: FLO-PRED

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 20085,881,926<disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-002Jan 17, 20086,102,254<disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-002Jan 17, 20085,881,926<disabled>
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Premature patent expiration for: FLO-PRED

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
6,656,482
FLO-PRED
December 02, 2015

Non-Orange Book Patents for Tradename: FLO-PRED

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
6,102,254 Pharmaceutical compositions in semisolid form and a device for administration thereof<disabled in preview>
8,206,727Oral suspension of prednisolone acetate<disabled in preview>
6,355,258 Method for formulating spill resistant pharmaceutical compositions in semi-solid form<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 Tradename: FLO-PRED

Country Document Number Estimated Expiration
Canada2118670<disabled in preview>
Japan5161722<disabled in preview>
Spain2242919<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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