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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, Novartis Pharms Corp, Pharmafair, Bausch And Lomb, and Novartis, and is included in twenty-seven NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-three patent family members in fourteen countries.

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

Summary for Generic Name: prednisolone acetate

Tradenames:18
Patents:4
Applicants:13
NDAs:27
Drug Master File Entries: see list85
Suppliers / Packagers: see list11
Bulk Api Vendors: see list40
Clinical Trials: see list548
Patent Applications: see list2,060
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:prednisolone acetate at DailyMed

Pharmacology for Ingredient: prednisolone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNoNo6,071,523► subscribeY ► subscribe
Schering
METICORTELONE
prednisolone acetate
INJECTABLE;INJECTION010255-002Approved Prior to Jan 1, 1982DISCNNoNo► subscribe► subscribe
Bel Mar
PREDNISOLONE ACETATE
prednisolone acetate
INJECTABLE;INJECTION083738-001Approved Prior to Jan 1, 1982DISCNNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: prednisolone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 20085,881,926► subscribe
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 20086,102,254► subscribe
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-002Jan 17, 20086,102,254► subscribe
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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
8,461,139Oral suspension of prednisolone acetate► subscribe
8,206,727Oral suspension of prednisolone acetate► subscribe
6,355,258 Method for formulating spill resistant pharmaceutical compositions in semi-solid form► subscribe
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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
Australia765798► subscribe
Israel189257► subscribe
Germany69928927► subscribe
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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