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Dexamethasone - Generic Drug Details

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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:	90
Clinical Trials:	2,042
Patent Applications:	5,742
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

Anti-Inflammatory Agents

Antiemetics

Antineoplastic Agents, Hormonal

Glucocorticoids

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
Watson Labs	DEXAMETHASONE	dexamethasone	TABLET;ORAL	085818-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018		RX	Yes	Yes
Watson Labs	DEXAMETHASONE ACETATE	dexamethasone acetate	INJECTABLE;INJECTION	084315-001	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for dexamethasone

Country	Document Number	Estimated Expiration
New Zealand	538380
European Patent Office	1296645
Australia	2002236495

Supplementary Protection Certificates for dexamethasone

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0012	France		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
C/GB12/058	United Kingdom		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
2012000081	Germany		PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727