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Last Updated: August 9, 2020

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PREDNISONE Drug Profile

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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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SponsorPhase
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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