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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.

Summary for methylprednisolone

US Patents:	0
Tradenames:	11
Applicants:	31
NDAs:	85
Drug Master File Entries:	40
Suppliers / Packagers:	30
Bulk Api Vendors:	77
Clinical Trials:	521
Patent Applications:	7,181
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for methylprednisolone
Drug Sales Revenues:	Drug sales revenues for methylprednisolone
DailyMed Link:	methylprednisolone at DailyMed

See drug prices for methylprednisolone

See drug sales revenues for methylprednisolone

Recent Clinical Trials for methylprednisolone

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

Sponsor	Phase
Hadassah Medical Organization	Phase 2
Takeda	Phase 2
Bristol-Myers Squibb	Phase 1/Phase 2

See all methylprednisolone clinical trials

Pharmacology for methylprednisolone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for methylprednisolone

Anti-Inflammatory Agents

Antiemetics

Glucocorticoids

Neuroprotective Agents

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
Pharmacia And Upjohn	DEPO-MEDROL	methylprednisolone acetate	INJECTABLE;INJECTION	011757-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Abbott	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	089576-001	Feb 22, 1991		DISCN	No	No
Sungen Pharma	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	212262-001	Jun 27, 2019	AB	RX	No	No
Watson Labs	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	088524-001	Jul 24, 1984		DISCN	No	No
Abbott	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	089574-001	Feb 22, 1991		DISCN	No	No
Organon Usa Inc	METHYLPREDNISOLONE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	087535-002	Jun 25, 1982		DISCN	No	No