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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 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, 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-eight NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has one hundred and sixty-four patent family members in twenty-seven countries.

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

Summary for dexamethasone

International Patents:	164
US Patents:	23
Tradenames:	33
Applicants:	53
NDAs:	128
Drug Master File Entries:	39
Suppliers / Packagers:	32
Bulk Api Vendors:	93
Clinical Trials:	2,256
Patent Applications:	7,361
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for dexamethasone
Drug Sales Revenues:	Drug sales revenues 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

.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
Sun Pharm Industries	DEXAMETHASONE	dexamethasone	TABLET;ORAL	084084-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Merck	DECADRON-LA	dexamethasone acetate	INJECTABLE;INJECTION	016675-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Intl Medication	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	088522-001	Feb 17, 1984		DISCN	No	No

International Patents for dexamethasone

Country	Patent Number	Estimated Expiration
Cyprus	1120147
Hungary	E030319
New Zealand	552679

Supplementary Protection Certificates for dexamethasone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	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
1581193	C300552	Netherlands		PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727