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Last Updated: December 9, 2019

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Prednisolone sodium phosphate - Generic Drug Details

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What are the generic sources for prednisolone sodium phosphate and what is the scope of patent protection?

Prednisolone sodium phosphate is the generic ingredient in thirteen branded drugs marketed by Merck, Watson Labs, Novartis, Schering, Pharmafair, Akorn, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal Pharms, Chartwell Rx, Edenbridge Pharms, Hi Tech Pharma, Medicis Pharms, Mission Pharma, Nesher Pharms, Pharm Assoc, Vintage, Vintage Pharms, We Pharms, Wockhardt Bio Ag, Mylan Pharms Inc, and Sandoz Inc, and is included in forty-one NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Prednisolone sodium phosphate has nine patent family members in seven countries.

There are eighty-eight drug master file entries for prednisolone sodium phosphate. Nineteen suppliers are listed for this compound.

Recent Clinical Trials for prednisolone sodium phosphate

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

SponsorPhase
Research to Prevent BlindnessPhase 2
Francis I. Proctor FoundationPhase 2
ORA, Inc.Phase 4

See all prednisolone sodium phosphate clinical trials

Recent Litigation for prednisolone sodium phosphate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
CIMA Labs Inc. v. Barr Laboratories Inc.2008-08-21
Cephalon Inc. v. Barr Pharmaceuticals Inc.2008-07-22

See all prednisolone sodium phosphate litigation

Pharmacology for prednisolone sodium phosphate
Synonyms for prednisolone sodium phosphate
[2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] dihydrogen phosphate
[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] dihydrogen phosphate
11beta,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate)
11beta,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-(disodium phosphate)
125-02-0
125P020
1263143-23-2
302-25-0
752SY38R6C
A805337
AB01563113_01
AC-2371
AC1L1J72
AC1L1LDT
AC1L2HDG
AC1L9B41
ACN-043360
AKOS015962823
AKOS025294226
AKOS025310687
AKOS025394281
AN-14017
ANW-41116
API0003920
AT-2935
BC214767
BCP11881
C21H27O8P.2Na
CCG-213527
CHEBI:8379
CHEMBL1201014
CHEMBL1201231
Codelsol
Cortisate-20 (Veterinary)
CS-2878
CTK8B2822
CTK8I0968
D00981
D3918
disodium [2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl)-2-oxo-ethyl] phosphate
disodium [2-(11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] phosphate
disodium [2-[(8S,9S,10R,11S,13S,14S,17R)-10,13-dimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] phosphate
disodium [2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate
Disodium prednisolone 21-phosphate
disodium;[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate
DTXSID2047480
DTXSID7047481
EINECS 204-722-9
EINECS 206-120-1
FT-0631728
HMS3264J09
HY-B0645
Hydeltrasol
I06-0770
Inflamase
Inflamase Forte
Inflamase Mild
IV021NXA9J
KB-296232
LS-118502
LS-174283
LS-187308
Metreton
Millipred
MolPort-019-991-120
NCGC00249889-01
NSC-759187
NSC759187
Optimyd
Optival
Pediapred (TN)
Pharmakon1600-01505712
Phortisolone
Predair
Predair Forte
Prednesol
Prednisolone (disodium phosphate)
Prednisolone 21-(dihydrogen phosphate)
Prednisolone 21-(disodium phosphate)
Prednisolone 21-phosphate disodium
Prednisolone 21-Phosphate Disodium Salt
Prednisolone disodium phosphate
Prednisolone phosphate
Prednisolone phosphate sodium
Prednisolone sodium phosphate (JP17/USP)
Prednisolone Sodium Phosphate [USAN:JAN]
Prednisolone sodium phosphate [USP:JAN]
Predsol
Predsolan
Pregna-1,4-diene-3,20-dione, 11-beta,17,21-trihydroxy-, 21-(dihydrogen phosphate), disodium salt
Pregna-1,4-diene-3,20-dione, 11-beta,17,21-trihydroxy-, 21-(dihydrogen phosphate),disodium salt
Pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11.beta.)-
Pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11beta)-
Prozorin
PSLP
Q-201615
SBI-0206886.P001
SCHEMBL136773
SCHEMBL1650407
SCHEMBL23563
sodium 2-((8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl phosphate
Sodium prednisolone phosphate
Solucort
ST24049032
TR-003806
UNII-752SY38R6C
UNII-IV021NXA9J
VA11575
Vasocidin Solution
Veripred 20
ZINC4097473
Paragraph IV (Patent) Challenges for PREDNISOLONE SODIUM PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
ORAPRED ODT TABLET, ORALLY DISINTEGRATING;ORAL prednisolone sodium phosphate 021959 2010-07-22
PEDIAPRED SOLUTION;ORAL prednisolone sodium phosphate 019157

US Patents and Regulatory Information for prednisolone sodium phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis VASOCIDIN prednisolone sodium phosphate; sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 018988-001 Aug 26, 1988 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pharm Assoc PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 076913-001 Apr 25, 2005 AA RX No No   Start Trial   Start Trial   Start Trial
We Pharms PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 075181-001 Dec 23, 2002 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 prednisolone sodium phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006   Start Trial   Start Trial
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006   Start Trial   Start Trial
Seton Pharm PEDIAPRED prednisolone sodium phosphate SOLUTION;ORAL 019157-001 May 28, 1986   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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