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: November 14, 2019

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Methylprednisolone - Generic Drug Details

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What are the generic sources for methylprednisolone and what is the scope of freedom to operate?

Methylprednisolone is the generic ingredient in eleven branded drugs marketed by Pharmacia And Upjohn, Duramed Pharms Barr, Heather, Jubilant Cadista, Lupin Ltd, Par Pharm, Riconpharma Llc, Sandoz, Sungen Pharma, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms, Bel Mar, Akorn, Amneal Pharms Co, Sagent Pharms, Sandoz Inc, Teva Pharms Usa, Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Aurobindo Pharma Ltd, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, and Teva Parenteral, and is included in eighty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for methylprednisolone. Thirty suppliers are listed for this compound.

Drug Prices for methylprednisolone

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Drug Sales Revenue Trends for methylprednisolone

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Recent Clinical Trials for methylprednisolone

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

SponsorPhase
Hadassah Medical OrganizationPhase 2
TakedaPhase 2
Bristol-Myers SquibbPhase 1/Phase 2

See all methylprednisolone clinical trials

Pharmacology for methylprednisolone
Medical Subject Heading (MeSH) Categories for methylprednisolone
Synonyms for methylprednisolone
.DELTA.1-6.alpha.-Methylhydrocortisone
(6?,11?)-11,17,21-Trihydroxy-6-methylpregna-1,4-diene-3,20-dione
(6a,11b)-11,17,21-Trihydroxy-6-methylpregna-1,4-diene-3,20-dione
(6alpha,11beta)-11,17,21-Trihydroxy-6-methylpregna-1,4-diene-3,20-dione
(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one
(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one
010M591
1-Dehydro-6alpha-methylhydrocortisone
11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione
11?,17?,21-Trihydroxy-6?-methyl-1,4-pregnadiene-3,20-dione
11beta,17,21-trihydroxy-6alpha-methyl-1,4-pregnadiene-3,20-dione
11beta,17,21-Trihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione
11beta,17alpha,21-Trihydroxy-6alpha-methyl-1,4-pregnadiene-3,20-dione
11beta,17alpha,21-Trihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione
121673-01-6
124684-EP2295426A1
124684-EP2295427A1
2639-EP2277861A1
2639-EP2286811A1
2639-EP2292595A1
2639-EP2295409A1
2639-EP2298778A1
2639-EP2305660A1
2639-EP2308562A2
2639-EP2314590A1
2639-EP2371811A2
4-08-00-03498 (Beilstein Handbook Reference)
570-35-4
6-alpha-Methylprednisolone
6-alpha-Methylprednisolone 100 microg/mL in Acetonitrile
6.alpha.-Methylprednisolone
6alpha-methyl prednisolone
6alpha-Methyl-11beta,17alpha,21-trihydroxy-1,4-pregnadiene-3,20-dione
6alpha-Methyl-11beta,17alpha,21-triol-1,4-pregnadiene-3,20-dione
6alpha-Methylprednisolone
6alpha-Methylprednisolone base
6alpha-Methylprednisolone, >=98%
6alpha-Methylprednisolone, VETRANAL(TM), analytical standard
83-43-2
AB2000257
AC1L1N7A
ACN-037579
AK163190
AKOS015969744
AN-15368
Artisone-wyeth
BDBM50103616
Besonia
BPBio1_000174
BRD-K35240538-001-03-1
BRD-K35240538-001-11-4
BRD-K35240538-001-26-2
BRN 2340300
BSPBio_000158
C-21225
CAS-83-43-2
CCG-220279
CHEBI:6888
CHEMBL650
CPD000058330
CS-2246
D00407
DB00959
delta(1)-6alpha-Methylhydrocortisone
delta(sup 1)-6-alpha-Methylhydrocortisone
Depo-Medrol (acetate)
Dopomedrol
DSSTox_CID_3300
DSSTox_GSID_23300
DSSTox_RID_76965
DTXSID7023300
EC 201-476-4
EINECS 201-476-4
Esametone
Firmacort
GTPL7088
H972
HMS1568H20
HMS2090B13
HMS2095H20
HMS2230D16
HMS3259J04
HMS3712H20
HSDB 3127
HY-B0260
KS-1273
Lemod
LMST02030178
LS-118498
M1665
Medesone
Medixon
Medlone 21
Medrate
Medrol
Medrol (TN)
Medrol adt pak
Medrol dosepak
Medrol;Solu-Medrol;Medrone
Medrone
MEPRDL
Mesopren
Metastab
Methyleneprednisolone
Methylprednisolon
Methylprednisolone (JP17/USP/INN)
Methylprednisolone [USAN:INN:BAN:JAN]
Methylprednisolone [USP:INN:BAN:JAN]
Methylprednisolone & Salts
Methylprednisolone for system suitability A, EuropePharmacopoeia (EP) Reference Standard
Methylprednisolone for system suitability, European Pharmacopoeia (EP) Reference Standard
Methylprednisolone, 6-alpha
Methylprednisolone, British Pharmacopoeia (BP) Reference Standard
Methylprednisolone, European Pharmacopoeia (EP) Reference Standard
Methylprednisolone, Pharmaceutical Secondary Standard; Certified Reference Material
Methylprednisolone, United States Pharmacopeia (USP) Reference Standard
Methylprednisolonum
Methylprednisolonum [INN-Latin]
methylprenisolone
Metilbetasone
Metilprednisolona
Metilprednisolona [INN-Spanish]
Metilprednisolone
Metilprednisolone [DCIT]
Metipred
Metrisone
Metrocort
Metysolon
MFCD00010591
MLS000028541
MLS001148159
MLS002207191
MLS002638721
Moderin
MolPort-002-528-554
NC00691
NCGC00016330-01
NCGC00022735-03
NCGC00022735-06
NCGC00255269-01
NCI60_001657
Nirypan
Noretona
NSC-19987
NSC19987
Opera_ID_1576
Predni N Tablinen
Prednisolone, 6.alpha.-methyl-
Prednisolone, 6alpha-methyl-
Prednisolone, methyl-
Prednol- L
Pregna-1,20-dione, 11,17,21-trihydroxy-6-methyl-, (6.alpha.,11.beta.)-
Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-6.alpha.-methyl-
Pregna-1,20-dione, 6.alpha.-methyl-11.beta.-17,21-trihydroxy-
Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6a,11b)-
Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6alpha,11beta)-
Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-6alpha-methyl-
Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-6alpha-methyl- (8CI)
Pregna-1,4-diene-3,20-dione, 6-alpha-methyl-11-beta-17,21-trihydroxy-
Prestwick_622
Prestwick0_000279
Prestwick1_000279
Prestwick2_000279
Prestwick3_000279
Promacortine
Q-201395
Reactenol
s1733
SAM002589984
SC-15861
SCHEMBL5084
Sieropresol
SMR000058330
Solomet
SPBio_002377
SR-01000003089
SR-01000003089-2
ST24048101
Summicort
Summicort;
Suprametil
Tox21_110376
Tox21_110376_1
Tox21_302018
U 7532
UNII-X4W7ZR7023
Urbason
Urbasone
VHRSUDSXCMQTMA-PJHHCJLFSA-N
Wyacort
X4W7ZR7023
ZINC3875560

US Patents and Regulatory Information for methylprednisolone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira A-METHAPRED methylprednisolone sodium succinate INJECTABLE;INJECTION 089173-001 Aug 18, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn DEPO-MEDROL methylprednisolone acetate INJECTABLE;INJECTION 011757-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbott A-METHAPRED methylprednisolone sodium succinate INJECTABLE;INJECTION 089576-001 Feb 22, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Sungen Pharma METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 212262-001 Jun 27, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 088524-001 Jul 24, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Abbott A-METHAPRED methylprednisolone sodium succinate INJECTABLE;INJECTION 089574-001 Feb 22, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Organon Usa Inc METHYLPREDNISOLONE methylprednisolone sodium succinate INJECTABLE;INJECTION 087535-002 Jun 25, 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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Boehringer Ingelheim

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