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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 eigthy 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

Suppliers / Packagers: see list3

Pharmacology for Tradename: FLO-PRED

Clinical Trials for: FLO-PRED

A Comparison of Three Different Formulations of Prednisolone Acetate 1%
Status: Completed Condition: Glaucoma; Cataract

Biomarkers of Prednisolone Treatment (P05888)
Status: Completed Condition: Insulin Resistance; Hyperglycemia; Glucose Intolerance

Preoperative Methylprednisolone in Endovascular Aortic Repair
Status: Completed Condition: Abdominal Aortic Aneurysms

The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia
Status: Completed Condition: Eosinophilic Pneumonia; Chronic Disease

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Status: Completed Condition: Eye Infections; Postoperative Complications

Methylprednisolone N Acetylcysteine in Hepatic Resections
Status: Terminated Condition: Ischemic Reperfusion Injury; Insufficiency; Hepatic, Postoperative; Liver Tumour

Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone
Status: Terminated Condition: Multiple Sclerosis

Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
Status: Recruiting Condition: Stomatitis; Oral Mucositis; Neoplasm of the Breast; Malignant Tumor of Breast

Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis
Status: Completed Condition: Progressive Multiple Sclerosis

Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Status: Suspended Condition: Acute Exacerbation of Remitting Relapsing Multiple Sclerosis; Clinically Isolated Syndrome

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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
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo7,799,331<disabled>Y <disabled>
prednisolone acetate
SUSPENSION;ORAL022067-002Jan 17, 2008RXYes7,799,331<disabled>Y <disabled>
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo5,881,926<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
8,206,727Oral 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>
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International Patent Family for Tradename: FLO-PRED

Country Document Number Publication Date
Australia2003271358Jan 29, 2004
European Patent Office1632224Oct 22, 2008
Germany69928927Aug 17, 2006
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Preferred citation:

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

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