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Last Updated: March 19, 2024

Prednisolone - Generic Drug Details


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What are the generic sources for prednisolone and what is the scope of patent protection?

Prednisolone is the generic ingredient in thirty-eight branded drugs marketed by Schering, Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, We Pharms, Muro, Teva, Halsey, Pharmacia And Upjohn, Ferndale Labs, Aurobindo Pharma Ltd, Barr, Bundy, Chartwell Molecular, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, 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, Epic Pharma Llc, Harrow Eye, Sandoz, Abbvie, Taro, Allergan, Alcon, Pharmafair, Novartis, Bausch And Lomb, Merck, Alcon Pharms Ltd, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Mission Pharma, Vintage, Vintage Pharms, and Xttrium Labs Inc, and is included in one hundred and twenty-four 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. Six 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haaglanden Medical CentrePhase 2
Amphia HospitalPhase 2
Maastricht University Medical CenterPhase 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
Bel Mar PREDNISOLONE ACETATE prednisolone acetate INJECTABLE;INJECTION 083738-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck HYDELTRASOL prednisolone sodium phosphate INJECTABLE;INJECTION 011583-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 216715-001 Oct 25, 2022 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis INFLAMASE MILD prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 080751-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mission Pharma PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 091396-001 Sep 13, 2010 AA RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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