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Hydrocortisone - Generic Drug Details

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What are the generic sources for hydrocortisone and what is the scope of hydrocortisone patent protection?

Hydrocortisone is the generic ingredient in seventy-five branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Lannett Co Inc, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising Pharms, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Dow Pharm, Medicis, Paddock Llc, Ani Pharms, Teva Pharms, Healthpoint, Pharmacia And Upjohn, Baker Norton, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Perrigo Co, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Mission Pharma, Pfizer, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Lannett, Nexgen Pharma Inc, Panray, Parke Davis, PII, Purepac Pharm, Roxane, Sandoz, Vintage, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Ferndale Labs, Sebela Ireland Ltd, Akorn, Bel Mar, Fera Pharms, Colgate, Genus Lifesciences, Glenmark Generics, Taro Pharm Inds, Precision Dermat, Yamanouchi, Lupin Ltd, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Intl Medication, G And W Labs Inc, Glenmark Pharms Ltd, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Sandoz Inc, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-one NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixty-five drug master file entries for hydrocortisone. Forty-five suppliers are listed for this compound.

Summary for hydrocortisone

US Patents:	2
Tradenames:	75
Applicants:	107
NDAs:	251
Drug Master File Entries:	65
Suppliers / Packagers:	45
Bulk Api Vendors:	83
Clinical Trials:	311
Patent Applications:	7,190
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for hydrocortisone
DailyMed Link:	hydrocortisone at DailyMed

Pharmacology for hydrocortisone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for hydrocortisone

Anti-Inflammatory Agents

Synonyms for hydrocortisone

(11alpha,14beta)-11,17,21-Trihydroxypregn-4-Ene-3,20-Dione

(11beta)-11,17,21-Trihydroxy-pregn-4-ene-3,20-dione

(11beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione

(1S,10S,11S,15S,17S,2R,14R)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl tetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-5-one

(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one

(1S,2R,10S,11S,14R,15S,17S)-14,17-DIHYDROXY-14-(2-HYDROXYACETYL)-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE

(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadec-6-en-5-one

(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one

(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one

(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one

(8xi,9xi,11beta,14xi)-11,17,21-trihydroxypregn-4-ene-3,20-dione

[3H]cortisol

1050676-88-4

11-beta-Hydrocortisone

11-beta-Hydroxycortisone

11,17,21-Trihydroxypregn-4-ene-3,20-dione, (11.beta.)-

11?,17?,21-Trihydroxypregn-4-ene-3,20-dione

11.beta.-Hydrocortisone

11.beta.-Hydroxycortisone

11.beta.,17,21-Trihydroxypregn-4-ene-3,20-dione

11.beta.,17,21-trihydroxyprogesterone

11.beta.,17.alpha.,21-Trihydroxy-4-pregnene-3,20-dione

11.beta.,17.alpha.,21-Trihydroxypregn-4-ene-3,20-dione

11|A,17|A,21-Trihydroxypregn-4-ene-3,20-dione; 17-Hydroxycorticosterone; 4-Pregnene-11|A,17|A,21-triol-3,20-dione; Cortisol; Kendall inverted exclamation mark s compound F; Reichstein inverted exclamation mark s substance M

11beta-cortisol

11beta-Hydrocortisone

11beta-Hydroxycortisone

11beta,17,21-Trihydroxypregn-4-ene-3,20-dione

11beta,17,21-Trihydroxyprogesterone

11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione

11beta,17alpha,21-Trihydroxypregn-4-ene-3,20-dione

17-hydrocorticosterone

17-Hydroxycorticosterone

17.alpha.-Hydroxycorticosterone

17alpha-Hydroxycorticosterone

2v95

3h-cortisol

4-(6-chloro-4-oxoquinazolin-3(4H)-yl)-N-(3-methoxyphenyl)piperidine-1-carboxamide

4-Pregnen-11.beta.,17.alpha.,21-triol-3,20-dione

4-Pregnen-11beta,17alpha,21-triol-3,20-dione

4-Pregnene-11.beta.,17.alpha.,21-triol-3,20-dione

4-Pregnene-11beta,17alpha,21-triol-3,20-dione

4p6x

50-23-7

50H237

6861-EP2269977A2

6861-EP2270008A1

6861-EP2277565A2

6861-EP2277566A2

6861-EP2277567A1

6861-EP2277568A2

6861-EP2277569A2

6861-EP2277570A2

6861-EP2292227A2

6861-EP2292280A1

6861-EP2292615A1

6861-EP2292617A1

6861-EP2295409A1

6861-EP2298778A1

6861-EP2305679A1

6861-EP2308562A2

6861-EP2314590A1

6861-EP2371811A2

7062-EP2269977A2

7062-EP2292228A1

7062-EP2295411A1

7062-EP2298747A1

7062-EP2301931A1

7062-EP2308851A1

7062-EP2308880A1

7062-EP2311811A1

7062-EP2314585A1

8056-08-4

80562-38-5

8063-42-1

92372-EP2280008A2

92372-EP2289483A1

92372-EP2305257A1

AB1009452

AC-12902

AC1L1L2B

ACETASOL HC

ACETIC ACID W/ HYDROCORTISONE

Acticort

Acticort (TN)

Aeroseb HC

Aeroseb-HC

AI3-25006

AJ-64104

AK130455

AKOS001582651

Ala-Cort

Ala-Scalp

Alacort

Algicirtis

Alphaderm

Alphaderm (Salt/Mix)

Amberin

AN-24370

Anflam

Anti-inflammatory hormone

Anucort

Anucort-HC

Anusol HC

Anusol HC (TN)

AnusolHC

Aquacort

Aquanil HC

AS-11651

B1951

B48448A1-24BA-47CA-8D9E-43E5BC949386

Balneol-hc

Barseb HC

Basan-Corti

BDBM13775

Beta-hc

Bio-0648

BP-20390

BPBio1_000544

BRD-K93568044-001-03-1

BSPBio_000494

C00735

CaldeCORT Spray

CALMURID HC

CAS-50-23-7

CCG-204683

CCRIS 5854

Cetacort

CHEBI:17650

CHEMBL389621

Chronocort

Clear aid

Cleiton

Cobadex

Colocort

Colocort (TN)

component of Lubricort

component of Neo-Cort-Dome

component of Otalgine

Compound F

Compound F (kendall)

COR-OTICIN

Corhydron

Cort-Dome

Cort-Quin (Salt/Mix)

Cortanal

Cortef

Cortef (TN)

Cortenema

Cortesal

Corticreme

Cortifair

Cortifan

Cortiment

Cortisol

Cortisol alcohol

Cortisol solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Cortisol, Hydrocortisone

Cortisolonum

Cortisporin

Cortisporin (Salt/Mix)

Cortisporin Otico

Cortispray

Cortolotion

Cortonema

Cortoxide

Cortril

CPD000653523

Cremesone

Cremicort-H

CS-2226

CTK8F3227

Cutisol

Cyclodextrin-encapsulated hydrocortisone

D00088

D0KR5B

DB00741

Delacort

Derm-Aid

Dermacort

Dermaspray

Dermil

Dermocortal

Dermolate

Dihydrocostisone

Dioderm

Dome-cort

Domolene-HC

DR001936

Drotic

Drotic (Salt/Mix)

DSSTox_CID_714

DSSTox_GSID_20714

DSSTox_RID_75753

DTXSID7020714

DuoCort

EC 200-020-1

Ef corlin

Efcorbin

Efcortelan

Efcortelin

EINECS 200-020-1

Eldecort

Eldercort

Epicort

Epicortisol

Epiderm H

Epitope ID:174851

Esiderm H

EU-0100594

Evacort

Ficortril

Fiocortril

Flexicort

Foille Insetti

Genacort

Genacort (lotion)

Glycort

GTPL2868

Gyno-Cortisone

H 4001

H-Cort

HC

HC (HYDROCORTISONE)

HC #1

HC #4

Heb Cort

Heb-Cort

Hi-cor

Hidalone

Hidro-Colisona

Hidrocortisona

Hidrocortisona [INN-Spanish]

HMS1569I16

HMS2090M04

HMS2096I16

HMS2230B18

HMS2235F17

HMS3259C05

HMS3261H10

HSDB 3339

HY-N0583

Hycort

Hycortol

Hycortole

Hydracort

Hydrasson

Hydro-Adreson

Hydro-Colisona

Hydro-RX

Hydrocort

Hydrocortal

Hydrocorticosterone

Hydrocortisone (Cortisol)

Hydrocortisone (JP15/USP/INN)

Hydrocortisone (JP17/USP/INN)

Hydrocortisone [INN:BAN:JAN]

Hydrocortisone [USP:INN:BAN:JAN]

Hydrocortisone alcohol

HYDROCORTISONE AND ACETIC ACID

Hydrocortisone base

Hydrocortisone for peak identification, European Pharmacopoeia (EP) Reference Standard

Hydrocortisone free alcohol

HYDROCORTISONE IN ABSORBASE

Hydrocortisone solution

Hydrocortisone solution, 50 muM, sterile-filtered, BioXtra, suitable for cell culture

Hydrocortisone-Water Soluble

Hydrocortisone-Water Soluble, BioReagent, suitable for cell culture

Hydrocortisone, >=98% (HPLC)

Hydrocortisone, 98%

Hydrocortisone, 98% 1g

Hydrocortisone, BioReagent, suitable for cell culture

Hydrocortisone, European Pharmacopoeia (EP) Reference Standard

Hydrocortisone, gamma-irradiated, powder, BioXtra, suitable for cell culture

Hydrocortisone, meets USP testing specifications

Hydrocortisone, pharmaceutical secondary standard; traceable to USP, PhEur and BP

Hydrocortisone, United States Pharmacopeia (USP) Reference Standard

Hydrocortisone, VETRANAL(TM), analytical standard

Hydrocortisonum

Hydrocortisonum [INN-Latin]

Hydrocortisyl

Hydrocortone

Hydroskin

Hydroxycortisone

Hysone

Hytisone

Hytone

Hytone (TN)

Hytone lotion

Idrocortisone

Idrocortisone [DCIT]

Incortin-H

Incortin-hydrogen

J10114

JYGXADMDTFJGBT-VWUMJDOOSA-N

Kendall's compound F

Kendalls compound F

Komed HC

Kyypakkaus

Lacticare HC

Lacticare-HC

Lactisona

LMST02030001

Lopac0_000594

LP00594

LS-7439

Lubricort

Maintasone

MCULE-8953627920

Medicort

Meusicort

MFCD00011654

Mildison

Milliderm

MLS000069609

MLS001148103

MLS002207135

MLS002222189

MLS002548868

MolPort-001-794-637

NC00456

NCGC00022848-06

NCGC00022848-07

NCGC00022848-09

NCGC00022848-10

NCGC00022848-11

NCGC00022848-12

NCGC00022848-13

NCGC00022848-14

NCGC00022848-15

NCGC00022848-17

NCGC00258369-01

NCGC00261279-01

NCI60_000118

Neo-Cort-Dome

Neo-Cort-Dome (Salt/Mix)

Neo-Cortef

Neosporin-H Ear

Nogenic HC

NSC 10483

NSC-10483

NSC10483

Nutracort

Nystaform-HC

Opera_ID_1292

Optef

ORLEX HC

Otalgine

Otalgine (Salt/Mix)

Otic-Neo-Cort-Dome

Otic-Neo-Cort-Dome (Salt/Mix)

Otobiotic (Salt/Mix)

Otocort

Otocort (Salt/Mix)

Otosone-F

Pediotic Suspension

Pediotic Suspension (Salt/Mix)

Penecort

Permicort

PL057585

Plenadren

Plenadren (TN)

Polcort H

Pregn-4-ene-3, 11,17,21-trihydroxy-, (11.beta.)-

Pregn-4-ene-3, 11.beta.,17,21-trihydroxy-

Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11 beta)-

Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11-beta)-

Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11.beta.)-

Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11b)-

Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-

Pregn-4-ene-3,20-dione, 11.beta.,17,21-trihydroxy-

Pregn-4-ene-3,20-dione, 11beta,17,21-trihydroxy-

Preparation H Hydrocortisone Cream

Prepcort

Prestwick_265

Prestwick0_000447

Prestwick1_000447

Prestwick2_000447

Prestwick3_000447

Prevex HC

Proctocort

Proctofoam

Proctosol-HC

Proctozone HC

Protocort

Q-201211

Rectasol-HC

Rectoid

Reichstein's substance M

Reichsteins substance M

Remederm HC

s1696

SAM002264617

Sanatison

SBB012589

SC-18577

Scalp-Cort

Scalpicin Capilar

SCHEMBL4148

Schericur

Scheroson F

Sigmacort

Signef

SMP1_000156

SMR000059022

SMR000653523

SPBio_002433

ST069286

Stie-cort

Stiefcorcil

Synacort

Systral Hydrocort

Tarcortin

Terra-cortril

Texacort

Texacort lotion 25

Timocort

Tox21_110883

Tox21_110883_1

Tox21_200815

Tox21_500594

Transderma H

Traumaide

U 1851

Uniderm

UNII-WI4X0X7BPJ

UPCMLD-DP133

UPCMLD-DP133:001

Vioform-Hydrocortisone (Salt/Mix)

VoSol HC

VoSol HC (Salt/Mix)

Vytone

WI4X0X7BPJ

Z2786051549

Zenoxone

ZINC13540519

US Patents and Regulatory Information for hydrocortisone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Mid Atlantic	HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	087795-001	May 3, 1983	AT	RX	No	No
Mission Pharma	TEXACORT	hydrocortisone	SOLUTION;TOPICAL	081271-001	Apr 17, 1992		RX	No	Yes
Watson Labs	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	084738-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fougera Pharms	CARMOL HC	hydrocortisone acetate; urea	CREAM;TOPICAL	080505-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Topiderm	HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	089273-001	Feb 17, 1989		DISCN	No	No
Usl Pharma	HYDROCORTISONE	hydrocortisone	OINTMENT;TOPICAL	088039-001	Sep 27, 1983		DISCN	No	No