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Last Updated: November 30, 2022

Prednisone - Generic Drug Details


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

Prednisone is the generic ingredient in thirteen branded drugs marketed by Hikma, Wockhardt, Muro, Actavis Labs Fl Inc, Horizon, Halsey, Bayer Pharms, Pharmacia And Upjohn, Ferndale Labs, Schering, Solvay, Parke Davis, Schwarz Pharma, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Everylife, Ferrante, Geneyork Pharms, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Sandoz, Scherer Labs, Sperti, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vintage Pharms, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and twenty-nine NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Prednisone has fifty-three patent family members in twenty-nine countries.

There are sixteen drug master file entries for prednisone. Forty-eight suppliers are listed for this compound.

Drug Prices for prednisone

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Drug Sales Revenue Trends for prednisone

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Recent Clinical Trials for prednisone

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SponsorPhase
University of California, DavisPhase 3
GenmabPhase 3
AbbViePhase 3

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Pharmacology for prednisone
Medical Subject Heading (MeSH) Categories for prednisone
Paragraph IV (Patent) Challenges for PREDNISONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RAYOS Delayed-release Tablets prednisone 1 mg, 2 mg, and 5 mg 202020 1 2012-11-26

US Patents and Regulatory Information for prednisone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-002 Jul 26, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms Ny PREDNISONE prednisone TABLET;ORAL 089597-001 Oct 5, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Molecular PREDNISONE prednisone TABLET;ORAL 080514-001 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

Expired US Patents for prednisone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-001 Jul 26, 2012 See Plans and Pricing See Plans and Pricing
Horizon RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-002 Jul 26, 2012 See Plans and Pricing See Plans and Pricing
Horizon RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-002 Jul 26, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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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 verification 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.