Assyro AI

FDA Orange Book · active-ingredient family

Prednisone

Prednisone is approved as 5 brand and 117 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RAYOS · NDA 202020

5

Brand (NDA)

117

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution, syrup, tablet, tablet, delayed release

ProductApplicantApplicationTEApproved
RAYOSRLD×3HORIZONNDA 202020—Jul 26, 2012
DELTASONERLD×5PHARMACIA AND UPJOHNNDA 009986—Approved Prior to Jan 1, 1982
METICORTENRLD×2SCHERINGNDA 009766—Approved Prior to Jan 1, 1982
PARACORTPARKE DAVISNDA 010962—Approved Prior to Jan 1, 1982
PREDNISONEROXANENDA 017109—Approved Prior to Jan 1, 1982

Generic (ANDA) products (117)

ProductApplicantApplicationTEApproved
PREDNISONE×2DR REDDYSANDA 219477—Oct 01, 2025
PREDNISONE×3POINTVIEW HLDINGSANDA 212629ABDec 05, 2023
PREDNISONE×5JUBILANT CADISTAANDA 040362ABApr 17, 2023
PREDNISONE×5AUROBINDO PHARMA LTDANDA 215672ABMar 28, 2022
PREDNISONEAUROBINDO PHARMA LTDANDA 215671ABNov 16, 2021
PREDNISONENOVITIUM PHARMAANDA 215246ABJul 06, 2021
PREDNISONE×5STRIDES PHARMAANDA 208412ABNov 20, 2020
PREDNISONESTRIDES PHARMAANDA 210785ABSep 02, 2020
PREDNISONE×2AMNEALANDA 213386ABJun 24, 2020
PREDNISONE×2AMNEALANDA 213385ABJun 16, 2020
PREDNISONE×5NOVITIUM PHARMAANDA 211575ABNov 15, 2019
PREDNISONEGENEYORK PHARMSANDA 211496—Dec 28, 2018
PREDNISONE×5GENEYORK PHARMSANDA 210525—Dec 07, 2018
PREDNISONE×3ACTAVIS LABS FL INCANDA 204867—Apr 25, 2017
PREDNISONEHIKMA PHARMSANDA 040890—Nov 01, 2010
PREDNISONEJUBILANT CADISTAANDA 040611ABJun 06, 2005
PREDNISONEPH HEALTHANDA 040584ABDec 21, 2004
PREDNISONEPH HEALTHANDA 040581ABDec 21, 2004
PREDNISONEHIKMA PHARMSANDA 040538—Jan 08, 2004
PREDNISONEPH HEALTHANDA 040392ABFeb 12, 2003
PREDNISONE×2PH HEALTHANDA 040256ABJul 12, 2002
PREDNISONERISINGANDA 089983—Jan 12, 1989
PREDNISONERISINGANDA 089984—Jan 12, 1989
PREDNISONEXTTRIUM LABS INCANDA 089726—Aug 02, 1988
PREDNISONEAMNEAL PHARMS NYANDA 089597—Oct 05, 1987
PREDNISONEAMNEAL PHARMS NYANDA 089598—Oct 05, 1987
PREDNISONEAMNEAL PHARMS NYANDA 089599—Oct 05, 1987
PREDNISONEAM THERAPANDA 089387—Nov 06, 1986
PREDNISONEAM THERAPANDA 089388—Nov 06, 1986
PREDNISONEAM THERAPANDA 089389—Nov 06, 1986
PREDNISONEWHITEWORTH TOWN PLSNANDA 089028—Jul 24, 1986
PREDNISONE×3SUN PHARM INDUSTRIESANDA 089247ABDec 04, 1985
PREDNISONE INTENSOLRLDHIKMAANDA 088810—Feb 20, 1985
PREDNISONERLDHIKMAANDA 088703—Nov 08, 1984
PREDNISONESUPERPHARMANDA 088865—Oct 25, 1984
PREDNISONESUPERPHARMANDA 088866—Oct 25, 1984
PREDNISONESUPERPHARMANDA 088867—Oct 25, 1984
PREDNISONEHIKMA PHARMSANDA 088465—Jun 01, 1984
PREDNISONEDURAMED PHARMS BARRANDA 088394—Oct 04, 1983
PREDNISONEDURAMED PHARMS BARRANDA 088395—Oct 04, 1983
PREDNISONEDURAMED PHARMS BARRANDA 088396—Oct 04, 1983
PREDNISONEUDLANDA 087984—Jan 18, 1983
PREDNISONEUDLANDA 087985—Jan 18, 1983
PREDNISONEUDLANDA 087986—Jan 18, 1983
LIQUID PREDMUROANDA 087611—Sep 07, 1982
PREDNISONEWATSON LABSANDA 087773—Jul 13, 1982
PREDNISONEWATSON LABSANDA 087772—Jul 13, 1982
PREDNISONERLDROXANEANDA 087833—May 04, 1982
PREDNISONERLD×6HIKMAANDA 080352ABApr 22, 1982
PREDNISONEVANGARDANDA 087682—Jan 15, 1982
PREDNISONEVANGARDANDA 087701—Jan 15, 1982
CORTANHALSEYANDA 087480—Approved Prior to Jan 1, 1982
DELTA-DOMEBAYER PHARMSANDA 080293—Approved Prior to Jan 1, 1982
FERNISONEFERNDALE LABSANDA 083364—Approved Prior to Jan 1, 1982
ORASONE×4SOLVAYANDA 083009—Approved Prior to Jan 1, 1982
ORASONESOLVAYANDA 085999—Approved Prior to Jan 1, 1982
PREDNICEN-MSCHWARZ PHARMAANDA 084655—Approved Prior to Jan 1, 1982
PREDNISONEAIPING PHARM INCANDA 080336—Approved Prior to Jan 1, 1982
PREDNISONEBUNDYANDA 083676—Approved Prior to Jan 1, 1982
PREDNISONECHARTWELL MOLECULARANDA 080514—Approved Prior to Jan 1, 1982
PREDNISONECHARTWELL MOLECULARANDA 084275BXApproved Prior to Jan 1, 1982
PREDNISONECHARTWELL RXANDA 083059—Approved Prior to Jan 1, 1982
PREDNISONECONTRACT PHARMACALANDA 080209—Approved Prior to Jan 1, 1982
PREDNISONEELKINS SINNANDA 080491—Approved Prior to Jan 1, 1982
PREDNISONEELKINS SINNANDA 085811—Approved Prior to Jan 1, 1982
PREDNISONE×3EVERYLIFEANDA 084440—Approved Prior to Jan 1, 1982
PREDNISONE×2FERRANTEANDA 080563—Approved Prior to Jan 1, 1982
PREDNISONEHALSEYANDA 080300—Approved Prior to Jan 1, 1982
PREDNISONEHEATHERANDA 080320—Approved Prior to Jan 1, 1982
PREDNISONEHEATHERANDA 084341—Approved Prior to Jan 1, 1982
PREDNISONEHEATHERANDA 084417—Approved Prior to Jan 1, 1982
PREDNISONEHEATHERANDA 085543—Approved Prior to Jan 1, 1982
PREDNISONEHEATHERANDA 086946—Approved Prior to Jan 1, 1982
PREDNISONEIMPAX LABSANDA 080782—Approved Prior to Jan 1, 1982
PREDNISONEINWOOD LABSANDA 080328—Approved Prior to Jan 1, 1982
PREDNISONEINWOOD LABSANDA 080306—Approved Prior to Jan 1, 1982
PREDNISONEINWOOD LABSANDA 080279—Approved Prior to Jan 1, 1982
PREDNISONEIVAX SUB TEVA PHARMSANDA 080283—Approved Prior to Jan 1, 1982
PREDNISONEIVAX SUB TEVA PHARMSANDA 084133—Approved Prior to Jan 1, 1982
PREDNISONEIVAX SUB TEVA PHARMSANDA 084134—Approved Prior to Jan 1, 1982
PREDNISONEKV PHARMANDA 084236—Approved Prior to Jan 1, 1982
PREDNISONELEDERLEANDA 086968—Approved Prior to Jan 1, 1982
PREDNISONEMARSHALL PHARMAANDA 080301—Approved Prior to Jan 1, 1982
PREDNISONEMUTUAL PHARMANDA 080701—Approved Prior to Jan 1, 1982
PREDNISONEMUTUAL PHARMANDA 086595—Approved Prior to Jan 1, 1982
PREDNISONEMUTUAL PHARMANDA 084634—Approved Prior to Jan 1, 1982
PREDNISONE×3MYLANANDA 083677ABApproved Prior to Jan 1, 1982
PREDNISONENYLOSANDA 085115—Approved Prior to Jan 1, 1982
PREDNISONE×3PANRAYANDA 080350—Approved Prior to Jan 1, 1982
PREDNISONEPHARMAVITEANDA 084662—Approved Prior to Jan 1, 1982
PREDNISONEPHOENIX LABS NYANDA 080321—Approved Prior to Jan 1, 1982
PREDNISONEPHOENIX LABS NYANDA 083807—Approved Prior to Jan 1, 1982
PREDNISONEPUREPAC PHARMANDA 080353—Approved Prior to Jan 1, 1982
PREDNISONEPUREPAC PHARMANDA 086062—Approved Prior to Jan 1, 1982
PREDNISONEPUREPAC PHARMANDA 086061—Approved Prior to Jan 1, 1982
PREDNISONEPVT FORMANDA 085151—Approved Prior to Jan 1, 1982
PREDNISONEREXALLANDA 080232—Approved Prior to Jan 1, 1982
PREDNISONERISINGANDA 084774—Approved Prior to Jan 1, 1982
PREDNISONERISINGANDA 085813—Approved Prior to Jan 1, 1982
PREDNISONESCHERER LABSANDA 080371—Approved Prior to Jan 1, 1982
PREDNISONE×3SPERTIANDA 080359—Approved Prior to Jan 1, 1982
PREDNISONESUN PHARM INDUSTRIESANDA 086596—Approved Prior to Jan 1, 1982
PREDNISONETEVAANDA 080397—Approved Prior to Jan 1, 1982
PREDNISONEUPSHER SMITHANDA 087471—Approved Prior to Jan 1, 1982
PREDNISONEUPSHER SMITHANDA 087470—Approved Prior to Jan 1, 1982
PREDNISONEVALEANT PHARM INTLANDA 080237—Approved Prior to Jan 1, 1982
PREDNISONEVITARINEANDA 080334—Approved Prior to Jan 1, 1982
PREDNISONEVITARINEANDA 080506—Approved Prior to Jan 1, 1982
PREDNISONEWATSON LABSANDA 080356ABApproved Prior to Jan 1, 1982
PREDNISONEWATSON LABSANDA 085084—Approved Prior to Jan 1, 1982
PREDNISONEWATSON LABSANDA 085162ABApproved Prior to Jan 1, 1982
PREDNISONEWATSON LABSANDA 085161ABApproved Prior to Jan 1, 1982
PREDNISONEWATSON LABSANDA 086813—Approved Prior to Jan 1, 1982
PREDNISONEWATSON LABSANDA 086867—Approved Prior to Jan 1, 1982
PREDNISONE×2WHITEWORTH TOWN PLSNANDA 084913—Approved Prior to Jan 1, 1982
PREDNISONEWHITEWORTH TOWN PLSNANDA 080343—Approved Prior to Jan 1, 1982
SERVISONELEDERLEANDA 080223—Approved Prior to Jan 1, 1982

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9504699Aug 03, 2027in 1 yr 2 mo
U-1362
8168218Jan 07, 2028in 1 yr 7 mo
ProductU-1269

Prednisone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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