Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 21, 2019

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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 West-ward Pharms Int, 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, 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 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-seven patent family members in thirty countries.

There are sixteen drug master file entries for prednisone. Forty-seven 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
PPDPhase 2/Phase 3
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB ChairPhase 2/Phase 3
Washington University School of MedicinePhase 1/Phase 2

See all prednisone clinical trials

Recent Litigation for prednisone

Identify potential future generic entrants

District Court Litigation
Case NameDate
HORIZON PHARMA AG v. PAR PHARMACEUTICAL COMPANIES, INC.2013-10-22
Horizon Pharma AG v. Watson Laboratories, Inc. - Florida2013-08-28
HORIZON PHARMA AG v. WATSON LABORATORIES, INC. - FLORIDA2013-08-26

See all prednisone litigation

Pharmacology for prednisone
Medical Subject Heading (MeSH) Categories for prednisone
Synonyms for prednisone
.delta. E
.delta.-Cortelan
.delta.-Cortisone
.delta.-Cortone
.delta.-E
.delta.(sup1)-Cortisone
.delta.1-Cortisone
.delta.1-Dehydrocortisone
.delta.sone
(1S,2R,10S,11S,14R,15S)-14-hydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-diene-5,17-dione
(1S,2R,10S,11S,14R,15S)-14-hydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0?,?.0??,??]heptadeca-3,6-diene-5,17-dione
(1S,2R,10S,11S,14R,15S)-14-hydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadeca-3,6-diene-5,17-dione
(8S,9S,10R,13S,14S,17R)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,12,14,15,16-octahydrocyclopenta[a]phenanthrene-3,11-dione
(8S,9S,10R,13S,14S,17R)-17-Hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,10,12,13,14,15,16,17-decahydro-3H-cyclopenta[a]phenanthrene-3,11(6H)-dione
(8xi,9xi,14xi)-17,21-dihydroxypregna-1,4-diene-3,11,20-trione
003P608
1-Cortisone
1-Dehydrocortisone
1,2-Dehydrocortisone
1,21-diol-3,11,20-trione
1,4-Pregnadiene-17-alpha,21-diol-3,11,20-trione
1,4-Pregnadiene-17alpha,21-diol-3,11,20-trione
17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
17alpha, 21-Dihydroxypregna-1,4-dien-3,11,20-trione
17alpha,21-Dihydroxy-1,4-pregnadiene-3,11,20-trione
17alpha,21-dihydroxypregna-1,4-diene-3,11,20-trione
53-03-2
68-59-7
7077-EP2269977A2
7077-EP2270014A1
7077-EP2275413A1
7077-EP2275420A1
7077-EP2277565A2
7077-EP2277566A2
7077-EP2277567A1
7077-EP2277568A2
7077-EP2277569A2
7077-EP2277570A2
7077-EP2281815A1
7077-EP2286811A1
7077-EP2287156A1
7077-EP2289892A1
7077-EP2289894A2
7077-EP2292280A1
7077-EP2295055A2
7077-EP2295409A1
7077-EP2295416A2
7077-EP2295426A1
7077-EP2295427A1
7077-EP2298743A1
7077-EP2298748A2
7077-EP2298764A1
7077-EP2298765A1
7077-EP2301933A1
7077-EP2305642A2
7077-EP2305660A1
7077-EP2308812A2
7077-EP2308833A2
7077-EP2308855A1
7077-EP2311453A1
7077-EP2311807A1
7077-EP2311827A1
7077-EP2311840A1
7077-EP2314590A1
AB2000169
AC-11112
AC1L1LB2
AC1Q29EZ
ACon0_000082
ACon1_000297
Adasone
AI3-52939
AJ-46419
AKOS005267096
AKOS007930684
Ancortone
Apo-Prednisone
AS-11685
BCP09049
Bicortone
BPBio1_000323
BRD-K85883481-001-04-2
BRD-K85883481-001-08-3
BRD-K85883481-001-25-7
BSPBio_000293
C07370
C21H26O5
Cartancyl
CAS-53-03-2
CCG-220077
CCRIS 2646
CHEBI:8382
CHEMBL635
Colisone
Cortan
Cortidelt
Cotone
CS-2159
CTK4J6918
Dacorten
Dacortin
DB00635
Decortancyl
Decortin
Decortisyl
Dehydrocortisone
Dekortin
Dellacort
Dellacort A
delta cortelan
Delta E
Delta E.
delta-1-Cortisone
delta-1-Dehydrocortisone
Delta-Cortelan
delta-Cortisone
delta-Cortone
Delta-Dome
delta(sup 1)-Cortisone
delta(sup 1)-Dehydrocortisone
Deltacortene
Deltacortisone
Deltacortone
Deltadehydrocortisone
Deltasone
Deltison
Deltisona
Deltisone
Deltra
Di-Adreson
Diadreson
DSSTox_CID_1185
DSSTox_GSID_21185
DSSTox_RID_75997
DTXSID4021185
Econosone
EINECS 200-160-3
EN300-52605
Encorton
Encortone
Enkortolon
Enkorton
Fernisone
Fiasone
GTPL7096
HMS1568O15
HMS2090J13
HMS2095O15
HMS2231I24
HMS3039K07
HMS3259I09
HMS3712O15
Hostacortin
HSDB 3168
HY-B0214
In-Sone
Incocortyl
J10219
Juvason
Kortancyl
Liquid Pred
Liquid Pree
Lisacort
LMST02030180
Lodotra
Lodtra
LS-1325
MCULE-2603291254
Me-Korti
MEGxm0_000443
Metacortandracin
Meticorten
Meticorten (Veterinary)
MFCD00003608
MLS001061265
MLS001304073
MLS001335907
MLS001335908
MLS002154191
MLS002207083
MLS002548880
MLS002638114
modified-release prednisone
MolPort-001-740-041
NC00475
NCGC00090766-01
NCGC00090766-02
NCGC00090766-03
NCGC00090766-04
NCGC00090766-05
NCGC00090766-07
NCGC00254096-01
NCGC00259113-01
NCI-C04897
NCI60_000008
NE42686
Nisona
Nizon
Novoprednisone
NSC 10023
NSC-10023
NSC10023
Nurison
Orasone
Origen Prednisone
P1276
Panafcort
Panasol
Paracort
Parmenison
Pehacort
Precort
Predeltin
Prednicen-M
Prednicorm
Prednicort
Prednicot
Prednidib
Prednilonga
Prednison
Prednisona
Prednisona [INN-Spanish]
Prednisone (Adasone)
Prednisone [INN:BAN]
Prednisone [USP:INN:BAN]
Prednisone for peak identification, European Pharmacopoeia (EP) Reference Standard
Prednisone Intensol
Prednisone solution, 100 mug/mL in acetonitrile, ampule of 1 mL, certified reference material
Prednisone, >=98%
Prednisone, 98%
Prednisone, British Pharmacopoeia (BP) Reference Standard
Prednisone, European Pharmacopoeia (EP) Reference Standard
Prednisone, Pharmaceutical Secondary Standard; Certified Reference Material
Prednisone, pharmaceutical secondary standard; traceable to USP, PhEur and BP
Prednisone, tested according to Ph.Eur.
Prednisone, United States Pharmacopeia (USP) Reference Standard
Prednisone(Adasone)
Prednisonum
Prednisonum [INN-Latin]
Prednitone
Prednizon
Prednovister
Pregna-1,11,20-trione, 17,21-dihydroxy-
Pregna-1,11,20-trione, 17,21-hydroxy-
Pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-
Pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-
Pregna-1,4-diene-3,11,20-trione, 17,21-hydroxy-
Pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy-
Presone
Prestwick_405
Prestwick0_000077
Prestwick1_000077
Prestwick2_000077
Prestwick3_000077
Pronison
Pronisone
Rayos
Rectodelt
Retrocortine
RTR-036991
s1622
SC-73986
SCHEMBL3288
Servisone
SK-Prednisone
SMR000718760
SMR001227202
Sone
SPBio_002214
SR-01000837536
SR-01000837536-3
ST24049033
Sterapred
Supercortil
Tox21_111014
Tox21_111014_1
Tox21_201564
Tox21_300196
TR-036991
U 6020
Ultracorten
Ultracortene
UNII-VB0R961HZT
VB0R961HZT
Winpred
WLN: L E5 B666 CV OV AHTTT&J A1 E1 FV1Q FQ
Wojtab
XOFYZVNMUHMLCC-ZPOLXVRWSA-N
Zenadrid
Zenadrid (veterinary)
Zenadrid [veterinary]
ZINC3875357

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
Valeant Pharm Intl PREDNISONE prednisone TABLET;ORAL 080237-001 Approved Prior to Jan 1, 1982 DISCN 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 Pharms PREDNISONE prednisone TABLET;ORAL 088465-001 Jun 1, 1984 AB RX No No   Start Trial   Start Trial   Start Trial
Inwood Labs PREDNISONE prednisone TABLET;ORAL 080328-001 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Moodys
Johnson and Johnson
Colorcon
Boehringer Ingelheim

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