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Methylprednisolone - Generic Drug Details
What are the generic drug 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, Novast Labs, Par Pharm, Sandoz, Sungen Pharma, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms, Bel Mar, Akorn, Amneal, Sagent Pharms Inc, 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-one 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: | 31 |
| Bulk Api Vendors: | 78 |
| Clinical Trials: | 537 |
| Patent Applications: | 7,050 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for methylprednisolone |
| Drug Sales Revenues: | Drug sales revenues for methylprednisolone |
| DailyMed Link: | methylprednisolone at DailyMed |
Recent Clinical Trials for methylprednisolone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Harbour BioMed (Guangzhou) Co. Ltd. | Phase 1 |
| Walter Reed National Military Medical Center | Phase 3 |
| Innovent Biologics (Suzhou) Co. Ltd. | Phase 1/Phase 2 |
Pharmacology for methylprednisolone
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott | A-METHAPRED | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 089575-001 | Feb 22, 1991 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 085374-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Bedford Labs | METHYLPREDNISOLONE SODIUM SUCCINATE | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 040662-001 | Feb 21, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Lupin Ltd | METHYLPREDNISOLONE | methylprednisolone | TABLET;ORAL | 209097-003 | Feb 22, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hikma | METHYLPREDNISOLONE SODIUM SUCCINATE | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 202691-002 | Feb 16, 2016 | AP | RX | 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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