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DEXAMETHASONE Drug Profile
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Dexamethasone is a drug marketed by Alpharma Us Pharms, Anima, Lannett Co Inc, Lyne, Wockhardt Bio Ag, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Ani Pharms Inc, ECR, Fera Pharms Llc, Heritage Pharma, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Watson Labs Teva, Akorn, Amneal, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Dr Reddys, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc. and is included in eighty-two NDAs.
The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are thirty-nine drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.
Summary for DEXAMETHASONE
| US Patents: | 0 |
| Applicants: | 42 |
| NDAs: | 82 |
| Suppliers / Packagers: | 24 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 2,451 |
| Patent Applications: | 4,490 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DEXAMETHASONE |
| Drug Sales Revenues: | Drug sales revenues for DEXAMETHASONE |
| DailyMed Link: | DEXAMETHASONE at DailyMed |
See drug prices for DEXAMETHASONE
Recent Clinical Trials for DEXAMETHASONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rigshospitalet, Denmark | Phase 3 |
| University of Pittsburgh Medical Center | Phase 4 |
| Walid HABRE | Phase 4 |
Pharmacology for DEXAMETHASONE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for DEXAMETHASONE
Synonyms for DEXAMETHASONE
| .delta.(sup 1)-9-.alpha.-Fluoro-16-.alpha.-methylcortisol |
| .gamma.corten |
| (11|A,16|A)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione; 9|A-Fluoro-16|A-methyl-11|A,17|A,21-trihydroxy-1,4-pregnadiene-3,20-dione; 9|A-Fluoro-16|A-methylprednisolone; Prednisolone F |
| (11beta,16alpha)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione |
| (11beta,16alpha)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione labeled with tritium |
| (1R,2S,10S,11S,13R,14R,15S,17S)-1-fluoro-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,13,15-trimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-5-one |
| (1R,2S,10S,11S,13R,14R,15S,17S)-1-fluoro-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,13,15-trimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-5-one |
| (1R,2S,10S,11S,13R,14R,15S,17S)-1-fluoro-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,13,15-trimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadeca-3,6-dien-5-one |
| (2S,10S,11S,15S,17S,1R,13R,14R)-1-fluoro-14,17-dihydroxy-14-(2-hydroxyacetyl)- 2,13,15-trimethyltetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-5-one |
| (3H)-Dexamethasone |
| (8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one |
| (8S,9R,10S,11S,13S,14S,16R,17R)-9-Fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]ph |
| (8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one |
| [3H]-dexamethasone |
| [3H]dexamethasone |
| 064D136 |
| 1-Dehydro-16.alpha.-methyl-9.alpha.-fluorohydrocortisone |
| 1-Dehydro-16alpha -methyl-9alpha -fluorohydrocortisone |
| 1-Dehydro-16alpha-methyl-9alpha-fluorohydrocortisone |
| 1050677-47-8 |
| 137098-19-2 |
| 16-.alpha.-Methyl-9-.alpha.-fluoro-1,17-.alpha.,21-triol-3,20-dione |
| 16-alpha-Methyl-9-alpha-fluoro-1-dehydrocortisol |
| 16-alpha-Methyl-9-alpha-fluoro-1,4-pregnadiene-11-beta,17-alpha,21-triol-3,20-dione |
| 16-alpha-Methyl-9-alpha-fluoro-11-beta,17-alpha,21-trihydroxypregna-1,4-diene-3,20-dione |
| 16-alpha-Methyl-9-alpha-fluoro-delta(sup 1)-hydrocortisone |
| 16-alpha-Methyl-9-alpha-fluoro-delta1-hydrocortisone |
| 16-alpha-Methyl-9-alpha-fluoroprednisolone |
| 16.alpha.-Methyl-9.alpha.-fluoro-.delta.(sup1)-hydrocortisone |
| 16.alpha.-Methyl-9.alpha.-fluoro-1-dehydrocortisol |
| 16.alpha.-Methyl-9.alpha.-fluoro-11.beta.-17.alpha.-21-trihydroxypregna-1,20-dione |
| 16.alpha.-Methyl-9.alpha.-fluoroprednisolone |
| 16alpha -Methyl-9alpha -fluoro-1-dehydrocortisol |
| 16alpha -Methyl-9alpha -fluoroprednisolone |
| 16alpha-Methyl-9alpha-fluoro-1-dehydrocortisol |
| 16alpha-Methyl-9alpha-fluoro-delta(sup 1)-hydrocortisone |
| 16alpha-Methyl-9alpha-fluoroprednisolone |
| 1793-EP2269977A2 |
| 1793-EP2269989A1 |
| 1793-EP2269990A1 |
| 1793-EP2270008A1 |
| 1793-EP2270014A1 |
| 1793-EP2270018A1 |
| 1793-EP2272832A1 |
| 1793-EP2275420A1 |
| 1793-EP2277565A2 |
| 1793-EP2277566A2 |
| 1793-EP2277567A1 |
| 1793-EP2277568A2 |
| 1793-EP2277569A2 |
| 1793-EP2277570A2 |
| 1793-EP2277861A1 |
| 1793-EP2277865A1 |
| 1793-EP2277876A1 |
| 1793-EP2279741A2 |
| 1793-EP2281563A1 |
| 1793-EP2289894A2 |
| 1793-EP2292227A2 |
| 1793-EP2292280A1 |
| 1793-EP2292589A1 |
| 1793-EP2292614A1 |
| 1793-EP2292617A1 |
| 1793-EP2295055A2 |
| 1793-EP2295402A2 |
| 1793-EP2295409A1 |
| 1793-EP2295412A1 |
| 1793-EP2295413A1 |
| 1793-EP2295416A2 |
| 1793-EP2298731A1 |
| 1793-EP2298743A1 |
| 1793-EP2298748A2 |
| 1793-EP2298764A1 |
| 1793-EP2298765A1 |
| 1793-EP2298772A1 |
| 1793-EP2298778A1 |
| 1793-EP2298779A1 |
| 1793-EP2298780A1 |
| 1793-EP2305248A1 |
| 1793-EP2305642A2 |
| 1793-EP2305663A1 |
| 1793-EP2305689A1 |
| 1793-EP2308562A2 |
| 1793-EP2308812A2 |
| 1793-EP2308833A2 |
| 1793-EP2308839A1 |
| 1793-EP2308880A1 |
| 1793-EP2311453A1 |
| 1793-EP2314585A1 |
| 1793-EP2314590A1 |
| 1793-EP2316459A1 |
| 1793-EP2316832A1 |
| 1793-EP2316833A1 |
| 1793-EP2316834A1 |
| 1793-EP2371811A2 |
| 1p93 |
| 23495-06-9 |
| 4-alpha-Fluoro-16-alpha-methyl-11-beta,17,21-trihydroxypregna-1,4-diene-3,20-dione |
| 4.alpha.-Fluoro-16.alpha.-methyl-11.beta.-17,4-diene-3,20-dione |
| 50-02-2 |
| 7S5I7G3JQL |
| 8054-59-9 |
| 9-alpha-Fluoro-16-alpha-methyl-1,4-pregnadiene-11-beta,17-alpha,21-triol-3,20-dione |
| 9-alpha-Fluoro-16-alpha-methylprednisolone |
| 9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione |
| 9-Fluoro-11.beta.,21-trihydroxy-16.alpha.-methylpregna-1,4-diene-3,20-dione |
| 9-Fluoro-11alpha -methylpregna-1,4-diene-3,20-dione |
| 9-Fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione |
| 9-Fluoro-16-methylprednisolone |
| 9-fluoro-16alpha-methyl-11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione |
| 9.alpha.-Fluoro-11.beta.-17.alpha.- 21-trihydroxy-16.alpha.-methylpregna-1,20-dione |
| 9.alpha.-Fluoro-16.alpha.-methyl-1,20-dione |
| 9.alpha.-Fluoro-16.alpha.-methyl-11.beta.,21.beta.-trihydroxy-pregna-1,4-diene-3,20-dione |
| 9.alpha.-Fluoro-16.alpha.-methylprednisolone |
| 906362-70-7 |
| 906422-84-2 |
| 9a-Fluoro-11b,17a,21-trihydroxy-16a-methylpregna-1,4-diene-3,20-dione |
| 9A-FLUORO-16BETA-METHYLPREDNISOLONE |
| 9alpha -Fluoro-16alpha -methylprednisolone |
| 9alpha-Fluoro-16alpha-methyl-11beta,17alpha,21-trihydroxy-1,4-pregnadiene-3,20-dione |
| 9alpha-fluoro-16alpha-methyl-Prednisolone |
| 9alpha-Fluoro-16alpha-methylprednisolone |
| AB0072035 |
| AB00918428_10 |
| AB00918428-05 |
| AB00918428-08 |
| AB00918428-09 |
| AB1009273 |
| AC-11056 |
| AC1L1L1H |
| AC1Q29DM |
| ACN-036253 |
| Adexone |
| Aeroseb-D |
| Aeroseb-Dex |
| AI3-50934 |
| AJ-46415 |
| Ak Dex Oph Otic Soln 0.1% |
| AKOS005259009 |
| AKOS015895509 |
| alpha -Fluoro-16-alpha -methylcortisol |
| Anaflogistico |
| Aphtasolon |
| Aphthasolone |
| Apo-dexamethasone |
| ARONIS27003 |
| Auxiron |
| Azimycin (Veterinary) |
| Azium |
| Azium (Veterinary) |
| BC201625 |
| BDBM18207 |
| BIDD:ER0494 |
| BIDD:PXR0060 |
| Bisu DS |
| BRD-K38775274-001-02-3 |
| BRD-K38775274-001-06-4 |
| BSPBio_000995 |
| C15643 |
| C22H29FO5 |
| Calonat |
| CAS-50-02-2 |
| CCRIS 7067 |
| CHEBI:41879 |
| CHEMBL384467 |
| Corson |
| Corsone |
| Cortisumman |
| CS-1505 |
| D00292 |
| DB01234 |
| Decacort |
| Decacortin |
| Decaderm |
| Decadron |
| Decadron (TN) |
| Decadron phosphate, Decdan, Dexacort, |
| Decadron Tablets, Elixir |
| Decagel |
| Decaject |
| Decaject-L.A. |
| Decalix |
| Decameth |
| Decasone |
| Decaspray |
| Dectancyl |
| Dekacort |
| delta(sup 1)-9-alpha-Fluoro-16-alpha-methylcortisol |
| delta1-9alpha-Fluoro-16alpha-methylcortisol |
| Deltafluorene |
| Dergramin |
| Deronil |
| Desadrene |
| Desametasone |
| Desametasone [DCIT] |
| Desamethasone |
| Desameton |
| Deseronil |
| Dex-ide |
| Dexa Mamallet |
| Dexa-Cortidelt |
| Dexa-Cortisyl |
| Dexa-Mamallet |
| Dexa-Scheroson |
| Dexa-sine |
| Dexacen-4 |
| Dexacidin |
| Dexacort |
| Dexacortal |
| Dexacortin |
| Dexadeltone |
| Dexafarma |
| Dexair |
| Dexalona |
| Dexaltin |
| Dexametasona |
| Dexametasona [INN-Spanish] |
| Dexametasone |
| Dexameth |
| Dexamethansone |
| Dexamethasone Cyclodextrin complex |
| Dexamethasone (DHAP) |
| Dexamethasone (JP17/USP/INN) |
| dexamethasone (tetramethyl-rhodamine conjugated ) |
| Dexamethasone [INN:BAN:JAN] |
| Dexamethasone [USP:INN:BAN:JAN] |
| Dexamethasone 1.0 mg/ml in Methanol |
| Dexamethasone alcohol |
| Dexamethasone Base |
| Dexamethasone for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Dexamethasone for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Dexamethasone Intensol |
| Dexamethasone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Dexamethasone-omega |
| Dexamethasone, >=97.0% (HPLC) |
| Dexamethasone, >=98% (HPLC), powder |
| Dexamethasone, 96% |
| Dexamethasone, British Pharmacopoeia (BP) Assay Standard |
| Dexamethasone, European Pharmacopoeia (EP) Reference Standard |
| Dexamethasone, meets USP testing specifications |
| Dexamethasone, Pharmaceutical Secondary Standard; Certified Reference Material |
| Dexamethasone, powder, BioReagent, suitable for cell culture, >=97% |
| Dexamethasone, powder, gamma-irradiated, BioXtra, suitable for cell culture, >=80% (HPLC) |
| Dexamethasone, tested according to Ph.Eur. |
| Dexamethasone, topical |
| Dexamethasone, United States Pharmacopeia (USP) Reference Standard |
| Dexamethasone, VETRANAL(TM), analytical standard |
| Dexamethasonum |
| Dexamethasonum [INN-Latin] |
| Dexamethazone |
| Dexamonozon |
| Dexapolcort |
| Dexapos |
| Dexaprol |
| DexaSite |
| Dexason |
| Dexasone |
| Dexasone 0.5mg |
| Dexasone 0.75mg |
| Dexasone 4mg |
| Dexinolon |
| Dexinoral |
| Dexone |
| Dexone 0.5 |
| Dexone 0.75 |
| Dexone 1.5 |
| Dexone 4 |
| Dexonium |
| Dexpak |
| Dextelan |
| Dextenza |
| Dezone |
| Dinormon |
| DSSTox_CID_384 |
| DSSTox_GSID_20384 |
| DSSTox_RID_75557 |
| DTXSID3020384 |
| DXM |
| DXM [Steroid] |
| Dxms |
| EINECS 200-003-9 |
| EN300-52607 |
| Fluormethylprednisolone |
| Fluormone |
| Fluorocort |
| Fortecortin |
| FT-0080377 |
| FT-0601576 |
| FT-0603100 |
| Gammacorten |
| GTPL2768 |
| GTPL3447 |
| Hexadecadrol |
| Hexadrol |
| Hexadrol Elixir |
| Hexadrol Tablets |
| Hl-dex |
| HMS1792A17 |
| HMS1990A17 |
| HMS2089N13 |
| HMS2235F08 |
| HMS3039L11 |
| HMS3259N11 |
| HMS3403A17 |
| HSDB 3053 |
| HY-14648 |
| I06-1196 |
| IBI-10090 |
| IontoDex |
| Isopto-Dex |
| ISV-305 |
| J10029 |
| KS-000048I3 |
| KS-1451 |
| Lokalison F |
| Loverine |
| LS-7300 |
| Luxazone |
| Maxidex |
| Maxidex Ont 0.1% |
| Maxidex Sus 0.1% |
| Maxitrol |
| MCULE-4773827191 |
| Mediamethasone |
| Methylfluorprednisolone |
| Mexidex |
| MFCD00064136 |
| Millicorten |
| MK 125 |
| MLS001055412 |
| MLS001332507 |
| MLS001332508 |
| MolMap_000018 |
| MolPort-003-846-433 |
| Mymethasone |
| Naquasone (Veterinary) |
| NC00645 |
| NCGC00091019-01 |
| NCGC00091019-02 |
| NCGC00091019-03 |
| NCGC00091019-04 |
| NCGC00091019-05 |
| NCGC00091019-06 |
| NCGC00091019-07 |
| NCGC00091019-08 |
| NCGC00257676-01 |
| NCI60_003067 |
| Neomycin and polymyxin b sulphates and dexamethasone |
| NSC 34521 |
| NSC-34521 |
| NSC34521 |
| Ocu-trol |
| Oradexon |
| Osurdex |
| OTO-104 |
| Ozurdex |
| Pet Derm III |
| Pet-Derm Iii |
| PHL-dexamethasone |
| PMS Dexamethasone Elixir 0.5mg/5ml |
| PMS-dexamethasone |
| Policort |
| Posurdex |
| Prednisolon F |
| Prednisolone F |
| Prednisolone, 9.alpha.-fluoro-16.alpha.-methyl- |
| Prednisolone, 9alpha -fluoro-16alpha -methyl- |
| Prednisolone, 9alpha-fluoro-16alpha-methyl- |
| Pregna-1,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11.beta.,16.alpha.)- |
| Pregna-1,20-dione, 9-fluoro-11.beta.,17,21-trihydroxy-16.alpha.-methyl- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11.beta.,16.alpha.)- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11beta,16alpha)- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, labeled with tritium, (11beta,16alpha)- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11alpha -methyl- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy-16alpha-methyl- |
| Prodex |
| Q-200939 |
| s1322 |
| Sandoz Dexamethasone |
| SC-16127 |
| SCHEMBL3774 |
| SGCUT00126 |
| SK-Dexamethasone |
| SMP1_000092 |
| SMR000857119 |
| SMR001227192 |
| Spectrum5_002019 |
| Spoloven |
| ST24046431 |
| ST50307091 |
| Sunia Sol D |
| Superprednol |
| sustained-release dexamethasone |
| TL8003317 |
| to_000038 |
| Tox21_200122 |
| Tresaderm (Veterinary) |
| Turbinaire |
| UNII-7S5I7G3JQL |
| UREBDLICKHMUKA-CXSFZGCWSA-N |
| Visumetazone |
| W-5058 |
| WLN: L E5 B666 OV KU MUTJ A1 BF CQ E1 FV1Q FQ G1 |
| Z802671480 |
| ZINC3875332 |
US Patents and Regulatory Information for DEXAMETHASONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 084355-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 085458-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Industries | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 084084-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs Teva | DEXAMETHASONE ACETATE | dexamethasone acetate | INJECTABLE;INJECTION | 087711-001 | May 24, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 040572-001 | Apr 22, 2005 | AP | RX | No | Yes | 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 |
