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Last Updated: March 19, 2024

PREDNISONE Drug Patent Profile


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

Prednisone is a drug marketed by Hikma, Xttrium Labs Inc, Actavis Labs Fl Inc, 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, Halsey, 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 seventeen NDAs.

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

DrugPatentWatch® 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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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
Jubilant Cadista PREDNISONE prednisone TABLET;ORAL 040362-003 Jun 29, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising PREDNISONE prednisone TABLET;ORAL 084774-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Geneyork Pharms PREDNISONE prednisone TABLET;ORAL 210525-002 Dec 4, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Everylife PREDNISONE prednisone TABLET;ORAL 084440-001 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

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