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Prednisolone acetate - Generic Drug Details

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Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Allergan, Cent Pharms, Akorn, Bel Mar, Pfizer, Watson Labs, Schering, Taro, Alcon, Pharmafair, Bausch And Lomb, and Novartis, and is included in twenty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eighty-two drug master file entries for prednisolone acetate. Six suppliers are listed for this compound.

Summary for Generic Name: prednisolone acetate

Tradenames:18
Patents:5
Applicants:12
NDAs:27
Drug Master File Entries: see list82
Suppliers / Packaging: see list6
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: prednisolone acetate

Clinical Trials for: prednisolone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
STERANE
prednisolone acetate
INJECTABLE;INJECTION011446-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Schering
METIMYD
prednisolone acetate; sulfacetamide sodium
OINTMENT;OPHTHALMIC010210-002Sep 9, 1984DISCNNo<disabled><disabled>
Watson Labs
PREDNISOLONE ACETATE
prednisolone acetate
INJECTABLE;INJECTION083654-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: prednisolone acetate

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

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>
8,461,139Oral 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 Ingredient: prednisolone acetate

Country Document Number Estimated Expiration
China101247786<disabled in preview>
European Patent Office0614659<disabled in preview>
Japan2009503097<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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