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Last Updated: November 13, 2019

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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 patent protection?

Dexamethasone is the generic ingredient in thirty-three 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, Ocular Therapeutix, Watson Labs, Novartis Pharms Corp, Eyepoint Pharms, 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, Solvay, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Akorn, Amneal Pharms Co, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Dr Reddys, 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 thirty NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has two hundred and one patent family members in thirty countries.

There are thirty-nine drug master file entries for dexamethasone. Twenty-eight suppliers are listed for this compound.

Drug Prices for DEXAMETHASONE

See drug prices for DEXAMETHASONE

Drug Sales Revenue Trends for DEXAMETHASONE

See drug sales revenues for DEXAMETHASONE

Recent Clinical Trials for DEXAMETHASONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaPhase 2
Heron TherapeuticsPhase 2
Assiut UniversityPhase 3

See all DEXAMETHASONE clinical trials

Pharmacology for DEXAMETHASONE
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
Merck NEODECADRON dexamethasone sodium phosphate; neomycin sulfate OINTMENT;OPHTHALMIC 050324-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs DEXAMETHASONE dexamethasone TABLET;ORAL 085818-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp TOBRADEX dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050592-001 Aug 18, 1988 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DEXAMETHASONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1581193 C300552 Netherlands   Start Trial PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
1429780 SPC/GB12/058 United Kingdom   Start Trial 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
1581193 122012000081 Germany   Start Trial PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
1429780 13C0012 France   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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