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METHYLPREDNISOLONE ACETATE - Generic Drug Details
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What are the generic sources for methylprednisolone acetate and what is the scope of patent protection?
Methylprednisolone acetate
is the generic ingredient in six branded drugs marketed by Pharmacia And Upjohn, Bel Mar, Akorn, Amneal Pharms Co, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, and Watson Labs, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There are forty drug master file entries for methylprednisolone acetate. Nine suppliers are listed for this compound.
Summary for METHYLPREDNISOLONE ACETATE
US Patents: | 0 |
Tradenames: | 6 |
Applicants: | 8 |
NDAs: | 19 |
Drug Master File Entries: | 40 |
Suppliers / Packagers: | 9 |
Bulk Api Vendors: | 46 |
Clinical Trials: | 24 |
Patent Applications: | 4,162 |
Formulation / Manufacturing: | see details |
DailyMed Link: | METHYLPREDNISOLONE ACETATE at DailyMed |
Recent Clinical Trials for METHYLPREDNISOLONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hadassah Medical Organization | Phase 2 |
Northwestern University | Phase 4 |
The University of Texas Medical Branch, Galveston | Phase 2 |
Pharmacology for METHYLPREDNISOLONE ACETATE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Synonyms for METHYLPREDNISOLONE ACETATE
(6.alpha.,11.beta.)-21-(Acetyloxy)-11,17-dihydroxy-6-methylpregna-1,4-diene-3,20-dione |
(6alpha,11beta)-11,17-dihydroxy-6-methyl-3,20-dioxopregna-1,4-dien-21-yl acetate |
[2-(11,17-dihydroxy-6,10,13-trimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] acetate |
[2-[(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] acetate |
[2-[(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate |
11,17-Dihydroxy-6-methyl-3,20-dioxopregna-1,4-dien-21-yl acetate |
11,17-Dihydroxy-6-methyl-3,20-dioxopregna-1,4-dien-21-yl acetate, (6.alpha.,11.beta.)- # |
11.beta.,17,21-Trihydroxy-6.alpha.-methylpregna-1,4-diene-3,20-dione 21-acetate |
11beta,17,21-Trihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione 21-acetate |
200M356 |
21-Acetoxy-11|A,17-dihydroxy-6|A-methylpregna-1,4-diene-3,20-dione |
43502P7F0P |
53-36-1 |
54299-EP2308562A2 |
54299-EP2371811A2 |
6-METHYLPREDNISOLONE ACETATE |
6.alpha.-Methylprednisolone 21-acetate |
6.alpha.-Methylprednisolone acetate |
6|A-Methyl Prednisolone 21-Acetate |
6alpha-Methyl Prednisolone 21-Acetate |
6alpha-Methylprednisolone 21-acetate |
6alpha-Methylprednisolone acetate |
A19446 |
AB0013042 |
AB00375925-05 |
AC-14387 |
AC-18907 |
AC1L1LBW |
AC1LBL10 |
AC1Q62P6 |
acetyl-methylprednisolone |
AKOS015961639 |
AKOS015969745 |
AKOS025401472 |
AKOS030242401 |
AN-9611 |
AS-13140 |
BCP11934 |
BDBM233194 |
C-22293 |
C08179 |
CAS-53-36-1 |
CC-30908 |
CHEBI:6889 |
CHEMBL1364144 |
component of Neo-Medrol |
CPD000718757 |
CTK4J7749 |
D-Med |
D00979 |
depMedalone 40 |
depMedalone 80 |
Depo-Medrate |
Depo-Medrin |
Depo-medrol |
Depo-medrol (TN) |
Depo-Medrone |
Depo-methylprednisolone |
Depo-Methylprednisolone acetate |
Depomedrone |
Depometicort |
Depot-Medrol |
DSSTox_CID_3302 |
DSSTox_GSID_23302 |
DSSTox_RID_76966 |
DTXSID7023302 |
EINECS 200-171-3 |
H421 |
HMS2233N14 |
HMS3259L07 |
Lemod Depo |
LS-118505 |
M-Predrol |
MCULE-6383206380 |
Medrol acetate |
Medrol Enpak |
Mepred |
methyl prednisolone 21-acetate |
Methyl prednisolone acetate |
Methylprednisolon-21-acetat |
Methylprednisolone 21-acetate |
Methylprednisolone 21-acetate; Depo-medrate |
Methylprednisolone acetate (JAN/USP) |
Methylprednisolone acetate [USAN:JAN] |
Methylprednisolone acetate [USP:JAN] |
methylprednisolone-21-acetate |
MLS001304003 |
MLS002667229 |
MolPort-002-528-604 |
MolPort-005-934-801 |
NC00628 |
NCGC00159503-02 |
Neo-Medrol (Salt/Mix) |
NSC 48985 |
NSC-48985 |
NSC48985 |
PLBHSZGDDKCEHR-LFYFAGGJSA-N |
PLBHSZGDDKCEHR-UHFFFAOYSA-N |
Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-6.alpha.-methyl-, 21-acetate |
Pregna-1,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6.alpha.,11.beta.)- |
Pregna-1,4-diene-3,20-dione, 11-beta,17,21-trihydroxy-6-alpha-methyl-, 21-acetate |
Pregna-1,4-diene-3,20-dione, 11.beta.,17,21-trihydroxy-6.alpha.-methyl-, 21-acetate |
Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-6alpha-methyl-, 21-acetate |
Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-6alpha-methyl-, 21-acetate (8CI) |
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6-alpha,11-beta)- |
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6.alpha.,11.beta.)- |
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6alpha,11beta)- |
SAM002699893 |
SCHEMBL13231 |
SCHEMBL145794 |
SCHEMBL1657958 |
SCHEMBL3437554 |
SMR000718757 |
SMR001556998 |
Solsolona |
Solsolona [inj.] |
Tox21_111722 |
U 8210 |
Ubrason |
Ubrason [inj.] |
Unidrol |
UNII-43502P7F0P |
Urbason crystal suspension |
Vetacortyl |
ZINC118912449 |
US Patents and Regulatory Information for METHYLPREDNISOLONE ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akorn | METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 086903-002 | Oct 20, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Amneal Pharms Co | METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 210043-002 | May 20, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Teva Pharms Usa | METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 040620-002 | Oct 27, 2006 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Bel Mar | M-PREDROL | methylprednisolone acetate | INJECTABLE;INJECTION | 087135-001 | 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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