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Last Updated: March 28, 2024

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, Xttrium Labs Inc, 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, Granulation Tech, 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

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

SponsorPhase
MacroGenicsPhase 2
Philippe Armand, MD, PhDPhase 2
Liaoning Tumor Hospital & InstitutePhase 2

See all prednisone clinical trials

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
Hikma Pharms PREDNISONE prednisone TABLET;ORAL 088465-001 Jun 1, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharmacia And Upjohn DELTASONE prednisone TABLET;ORAL 009986-008 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heather PREDNISONE prednisone TABLET;ORAL 080320-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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

Expired US Patents for prednisone

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

International Patents for prednisone

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2004093843 ⤷  Try a Trial
Mexico PA05011446 TABLETA CON LIBERACION RETARDADA CON GEOMETRIA DE NUCLEO DEFINIDA. (DELAYED RELEASE TABLET WITH DEFINED CORE GEOMETRY.) ⤷  Try a Trial
Russian Federation 2005132451 ТАБЛЕТКА ОСОБОЙ ГЕОРМЕТРИЧЕСКОЙ ФОРМЫ С МЕДЛЕННЫМВЫСВОБОЖДЕНИЕМ АКТИВНОГО ВЕЩЕСТВА ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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