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Profile for Tradename: FLO-PRED

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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 seventy-nine drug master file entries for this compound. Twelve 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: see list1

Pharmacology for Tradename: FLO-PRED

Clinical Trials for: FLO-PRED

Glossary
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;ORAL022067-002Jan 17, 2008RXYes6,071,523<disabled>Y<disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-002Jan 17, 2008RXYes7,799,331<disabled>Y<disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo6,071,523<disabled>Y<disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo5,881,926<disabled>Y<disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo7,799,331<disabled>Y<disabled>
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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
8,461,139Oral suspension of prednisolone acetate<disabled in preview>
6,102,254 Pharmaceutical compositions in semisolid form and a device for administration thereof<disabled in preview>
6,355,258 Method for formulating spill resistant pharmaceutical compositions in semi-solid form<disabled in preview>
8,206,727Oral suspension of prednisolone acetate<disabled in preview>
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International Patent Family for Tradename: FLO-PRED

Country Document Number Publication Date
Australia5762894Sep 15, 1994
Japan3417991Jun 16, 2003
Israel170790Jul 20, 2009
South Africa9401002Sep 30, 1994
European Patent Office1082103Mar 14, 2001
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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.

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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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