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Dexamethasone - Generic Drug Details
What are the generic sources for dexamethasone and what is the scope of dexamethasone freedom to operate?
Dexamethasone
is the generic ingredient in thirty-two branded drugs marketed by Allergan Herbert, Merck, West-ward Pharms Int, Alpharma Us Pharms, Lannett Co Inc, Lyne, Sti Pharma Llc, Wockhardt Bio Ag, Aspen Global Inc, Allergan, Watson Labs, Novartis Pharms Corp, Eyepoint Pharms, Ani Pharms Inc, ECR, Fera Pharms Llc, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Solvay, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Akorn, Amneal Pharms Co, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset Theraps Llc, Teva Parenteral, Wyeth Ayerst, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz Inc, Alcon Pharms Ltd, Novartis, and Perrigo Co Tennessee, and is included in one hundred and twenty-seven NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are thirty-nine drug master file entries for dexamethasone. Thirty suppliers are listed for this compound.
Summary for dexamethasone
| US Patents: | 22 |
| Tradenames: | 32 |
| Applicants: | 52 |
| NDAs: | 127 |
| Drug Master File Entries: | 39 |
| Suppliers / Packagers: | 30 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 2,187 |
| Patent Applications: | 7,384 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for dexamethasone |
| DailyMed Link: | dexamethasone at DailyMed |
Pharmacology for dexamethasone
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for dexamethasone
Synonyms for dexamethasone
| (11|A,16|A)-9-Fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione |
| (11alpha,16alpha)-9-Fluoro-11,17-Dihydroxy-16-Methyl-3,20-Dioxopregna-1,4-Dien-21-Yl Dihydrogen Phosphate |
| (11beta,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl dihydrogen phosphate |
| (11beta,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate |
| [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] dihydrogen phosphate |
| {2-[(1R,2S,10S,11S,13R,14R,15S,17S)-1-FLUORO-14,17-DIHYDROXY-2,13,15-TRIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-3,6-DIEN-14-YL]-2-OXOETHOXY}PHOSPHONIC ACID |
| 1869-92-7 |
| 21-Disodium phosphate dexamethasone |
| 2392-39-4 |
| 2BP70L44PR |
| 312-93-6 |
| 392D394 |
| 3T5 |
| 3tc5 |
| 54302-EP2305219A1 |
| 54302-EP2308562A2 |
| 54302-EP2371811A2 |
| 55203-24-2 |
| 65184-38-5 |
| 9-Fluoro-11|A,17,21-trihydroxy-16|A-methylpregna-1,4-diene-3,20-dione 21-Phosphate |
| 9-Fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate) |
| 9-Fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt |
| A816989 |
| A830522 |
| AB1009274 |
| AC-17992 |
| AC1L1SYG |
| AC1L291E |
| AC1NTURW |
| AC1Q1UXS |
| AI9376Y64P |
| AJ-46482 |
| AK-51738 |
| Ak-Dex |
| AK103580 |
| AKOS015896357 |
| AKOS015951212 |
| AKOS016007098 |
| AM84812 |
| AN-14018 |
| AN-40448 |
| AN-50017 |
| AX8235119 |
| Baldex |
| BC213122 |
| BDBM235670 |
| Betnelan phosphate |
| C08175 |
| C22H28FNa2O8P |
| C22H28FO8P.2Na |
| CAS-2392-39-4 |
| CHEBI:4462 |
| CHEBI:68637 |
| CHEBI:68638 |
| CHEMBL1200637 |
| CHEMBL1201302 |
| CHEMBL2021430 |
| Colvasone |
| CS-0013899 |
| D00975 |
| D07802 |
| D0NA8U |
| Dalalone |
| Dalalone (TN) |
| Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream |
| Decadron phosphate |
| Decadron-phosphate (TN) |
| Decdan |
| Dex 21-P (red blood cell encapsulated), Urbino University/EryDel |
| Dexabene |
| Dexadreson |
| Dexagel |
| Dexagro |
| Dexaject SP |
| Dexamethason sodium phosphate |
| Dexamethasone 21-(dihydrogen phosphate) |
| Dexamethasone 21-(disodium phosphate) |
| Dexamethasone 21-(sodium hydrogen phosphate) |
| Dexamethasone 21-Dihydrogen Phosphate |
| Dexamethasone 21-orthophosphate |
| Dexamethasone 21-phosphate |
| Dexamethasone 21-phosphate disodium salt |
| Dexamethasone 21-phosphate disodium salt, >=98% |
| Dexamethasone disodium phosphate |
| Dexamethasone Orthophosphate |
| dexamethasone phosphate |
| Dexamethasone phosphate disodium |
| dexamethasone phosphate(2-) |
| DEXAMETHASONE PHOSPHORIC ACID |
| DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone sodium phosphate (erythrocyte encapsulated) |
| Dexamethasone sodium phosphate (erythrocyte encapsulated), Urbino University/EryDel |
| Dexamethasone sodium phosphate (JAN/USP) |
| Dexamethasone Sodium Phosphate [USAN:BAN:JAN] |
| Dexamethasone sodium phosphate [USP:BAN:JAN] |
| Dexamethasone sodium phosphate for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Dexamethasone sodium phosphate, European Pharmacopoeia (EP) Reference Standard |
| Dexamethasone Sodium Phosphate, pharmaceutical secondary standard; traceable to USP, PhEur, BP |
| Dexamethasone sodium phosphate, United States Pharmacopeia (USP) Reference Standard |
| Dexamethasone-21-dihydrogen-phosphate |
| Dexamethasone-21-phosphate |
| Dexamethasone-21-phosphate disodium salt |
| dexamethasone; |
| Dexamethasone21-phosphatedisodiumsalt |
| DEXAMETHASONESODIUMPHOSPHATE |
| Dexamethazone sodium phosphate |
| disodium (1R,2S,10S,11S,13R,14R,15S,17S)-1-fluoro-14,17-dihydroxy-2,13,15-trimethyl-14-[2-(phosphonatooxy)acetyl]tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-5-one |
| disodium (1R,2S,10S,11S,13R,14R,15S,17S)-1-fluoro-14,17-dihydroxy-2,13,15-trimethyl-14-[2-(phosphonatooxy)acetyl]tetracyclo[8.7.0.0?,?.0??,??]heptadeca-3,6-dien-5-one |
| disodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoranyl-10,13,16-trimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] phosphate |
| disodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] phosphate |
| disodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate |
| disodium 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate |
| Disodium dexamethasone phosphate |
| disodium;[2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate |
| DSSTox_CID_27429 |
| DSSTox_GSID_47429 |
| DSSTox_RID_82342 |
| DTXSID2047430 |
| DTXSID3047429 |
| EBD26577 |
| EINECS 206-232-0 |
| EINECS 217-487-2 |
| EINECS 219-243-0 |
| EN300-52795 |
| erydex |
| FT-0603099 |
| FT-0659571 |
| FT-0666306 |
| Hexadrol Injectable |
| Hexadrol phosphate |
| HMS2231O20 |
| HY-B1829A |
| I06-1906 |
| Intra-erythrocyte dexamethasone (inflammatory diseases), Urbino University/EryDel |
| J10230 |
| KB-271918 |
| KB-296233 |
| KS-1150 |
| LS-118469 |
| LS-118471 |
| LS-187216 |
| Maxidex Ointment |
| Megacort |
| MFCD00079105 |
| Micromethason |
| MLS000069568 |
| MLS000863280 |
| MLS001076081 |
| MolPort-002-529-303 |
| MolPort-005-937-094 |
| MQRFYYBWKRACSJ-WKSAPEMMSA-M |
| NCGC00021226-03 |
| NCGC00021226-04 |
| NCGC00094644-01 |
| NCGC00256783-01 |
| Neodecadron |
| Onadron |
| Opera_ID_74 |
| Oradexon phosphate |
| Orgadrone |
| Phosphoric acid hydrogen (9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-21-yl)=sodium ester salt |
| PL009466 |
| PLCQGRYPOISRTQ-FCJDYXGNSA-L |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-, 21-(dihydrogen phosphate) |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-, 21-(dihydrogen phosphate) disodium salt |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy- 16-methyl-21-(phosphonooxy)-, (11ss,16?)- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11beta,16alpha)- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, sodium salt (1:2), (11beta,16alpha)- |
| Q-200940 |
| s4028 |
| SC-18764 |
| SCHEMBL135283 |
| SCHEMBL3694078 |
| SCHEMBL7778 |
| SMR000058813 |
| sodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] hydrogen phosphate |
| sodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate |
| Sodium dexamethasone phosphate |
| Soldesam |
| Solu-Decadron |
| Spersadox |
| STOCK1N-57166 |
| TL8001979 |
| Tox21_113181 |
| Tox21_302586 |
| UNII-2BP70L44PR |
| UNII-AI9376Y64P |
| VQODGRNSFPNSQE-CXSFZGCWSA-N |
| Wymesone |
| ZINC3876071 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck | DECADRON | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 012071-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Watson Labs | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 089169-001 | Apr 9, 1986 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Watson Labs | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 084457-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| West-ward Pharms Int | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088316-001 | Sep 15, 1983 | BP | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Intl Medication | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 088522-001 | Feb 17, 1984 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
International Patents for dexamethasone
| Country | Document Number | Estimated Expiration |
|---|---|---|
| China | 105407896 | ➤ Sign Up |
| Norway | 325505 | ➤ Sign Up |
| Hong Kong | 1156856 | ➤ Sign Up |
| Mexico | PA05007342 | ➤ Sign Up |
| South Korea | 20160040471 | ➤ Sign Up |
| Taiwan | 200635565 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for dexamethasone
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0012 | France | ➤ Sign Up | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
| 2012000081 | Germany | ➤ Sign Up | PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727 |
| C/GB12/058 | United Kingdom | ➤ Sign Up | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
| C/GB12/047 | United Kingdom | ➤ Sign Up | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
| 00552 | Netherlands | ➤ Sign Up | PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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