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Last Updated: August 9, 2020

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When do Prednisone patents expire, and what generic alternatives are available?

Prednisone is a drug marketed by Hikma, Wockhardt, Actavis Labs Fl Inc, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Bundy, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Everylife, Ferrante, Geneyork Pharms, Halsey, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lannett, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Roxane, Sandoz, Scherer Labs, Sperti, 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 nine NDAs.

The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the prednisone profile page.

US ANDA Litigation and Generic Entry Outlook for Prednisone

A generic version of PREDNISONE was approved as prednisone by WATSON LABS on December 31st, 1969.

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Drug patent expirations by year for PREDNISONE
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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GRADE OnlusPhase 3
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB ChairPhase 2/Phase 3
PPDPhase 2/Phase 3

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Pharmacology for PREDNISONE
Medical Subject Heading (MeSH) Categories for PREDNISONE
Paragraph IV (Patent) Challenges for PREDNISONE
Tradename Dosage Ingredient NDA Submissiondate
RAYOS TABLET, DELAYED RELEASE;ORAL prednisone 202020 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
Novitium Pharma PREDNISONE prednisone TABLET;ORAL 211575-001 Nov 15, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Superpharm PREDNISONE prednisone TABLET;ORAL 088866-001 Oct 25, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma PREDNISONE prednisone TABLET;ORAL 087800-001 Apr 22, 1982 AB RX No Yes   Start Trial   Start Trial   Start Trial
Geneyork Pharms PREDNISONE prednisone TABLET;ORAL 210525-001 Dec 4, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Purepac Pharm PREDNISONE prednisone TABLET;ORAL 086061-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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.