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Last Updated: August 11, 2022

Prednisolone - Generic Drug Details


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What are the generic drug sources for prednisolone and what is the scope of freedom to operate?

Prednisolone is the generic ingredient in thirty-eight branded drugs marketed by Schering, Akorn, Chartwell Rx, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Teva Pharms, We Pharms, Wockhardt Bio Ag, Muro, Teva, Halsey, Pharmacia And Upjohn, Ferndale Labs, Barr, Bundy, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Lannett, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rising, Roxane, Sperti, Superpharm, Tablicaps, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Pfizer, Bel Mar, Cent Pharms, Eyevance, Novartis, Allergan, Taro, Alcon, Pharmafair, Bausch And Lomb, Merck, Alcon Pharms Ltd, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal Pharms, Bausch, Edenbridge Pharms, Mission Pharma, Vintage, Vintage Pharms, Mylan Pharms Inc, and Sandoz Inc, and is included in one hundred and twenty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighty-eight drug master file entries for prednisolone. Eight suppliers are listed for this compound.

Drug Prices for prednisolone

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Drug Sales Revenue Trends for prednisolone

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Recent Clinical Trials for prednisolone

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SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
University of OuluPhase 4
Sparrow PharmaceuticalsPhase 2

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Pharmacology for prednisolone
Medical Subject Heading (MeSH) Categories for prednisolone

US Patents and Regulatory Information for prednisolone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett Co Inc PREDNISOLONE prednisolone SYRUP;ORAL 040775-001 Sep 21, 2007 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn PREDNISOLONE ACETATE prednisolone acetate INJECTABLE;INJECTION 084492-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vitarine PREDNISOLONE prednisolone TABLET;ORAL 080534-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for prednisolone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
LE VET B.V. Equisolon Prednisolone EMEA/V/C/002382
Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.
Authorised no no no 2014-03-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

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