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Last Updated: July 11, 2020

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PREDNISONE - Generic Drug Details

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

Prednisone is the generic ingredient in thirteen branded drugs marketed by Hikma, Wockhardt, Muro, Actavis Labs Fl Inc, Horizon Pharma Usa, Halsey, Bayer Pharms, Pharmacia And Upjohn, Ferndale Labs, Schering, Solvay, Parke Davis, Schwarz Pharma, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Bundy, 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, 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 twenty-one NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Prednisone has sixty-eight patent family members in thirty countries.

There are sixteen drug master file entries for prednisone. Forty-five 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
GRADE OnlusPhase 3
PPDPhase 2/Phase 3
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB ChairPhase 2/Phase 3

See all PREDNISONE clinical trials

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
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
Whiteworth Town Plsn PREDNISONE prednisone TABLET;ORAL 084913-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ferndale Labs FERNISONE prednisone TABLET;ORAL 083364-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Horizon Pharma Usa RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-002 Jul 26, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon Pharma Usa RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-002 Jul 26, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Duramed Pharms Barr PREDNISONE prednisone TABLET;ORAL 088394-001 Oct 4, 1983 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

Expired US Patents for PREDNISONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Pharma Usa RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-001 Jul 26, 2012   Start Trial   Start Trial
Horizon Pharma Usa RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-002 Jul 26, 2012   Start Trial   Start Trial
Horizon Pharma Usa RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-002 Jul 26, 2012   Start Trial   Start Trial
Horizon Pharma Usa RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020-001 Jul 26, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Colorcon
Baxter
McKesson
Mallinckrodt

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