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Last Updated: December 14, 2019

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HYDROCORTISONE ACETATE Drug Profile

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When do Hydrocortisone Acetate patents expire, and when can generic versions of Hydrocortisone Acetate launch?

Hydrocortisone Acetate is a drug marketed by Cenci, Ferndale Labs, Parke Davis, Purepac Pharm, Akorn, Bel Mar, Watson Labs, Fera Pharms, X Gen Pharms, and Genus Lifesciences. and is included in thirteen NDAs.

The generic ingredient in HYDROCORTISONE ACETATE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.

Summary for HYDROCORTISONE ACETATE
Drug patent expirations by year for HYDROCORTISONE ACETATE
Recent Clinical Trials for HYDROCORTISONE ACETATE

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

SponsorPhase
Children's Hospital Los AngelesPhase 2
University of MichiganPhase 2
Feinstein Institute for Medical ResearchPhase 2

See all HYDROCORTISONE ACETATE clinical trials

Synonyms for HYDROCORTISONE ACETATE
[2-[(8S,9S,10R,11S,13S,14S,17R)-10,13-dimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] ethanoate
[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] acetate
[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate
037H714
11-beta,17-alpha-Dihydroxy-21-acetoxypregesterone
11,17-Dihydroxy-3,20-dioxopregn-4-en-21-yl acetate, (11.beta.)-
11.beta.,17.alpha.-Dihydroxy-21-acetoxypregesterone
11.beta.,17.alpha.,21-Trihydroxypregn-4-ene-3,20-dione 21-acetate
11.beta.17.alpha.-Dihydroxy-21-acetoxypregesterone
11|A,17|A,21-EyoC>>u-4-OEthI(c)-3,20- paragraph signthornI feminine 21-OOEao yen
11beta,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate
11beta,17,21-trihydroxypregn-4-ene-3,20-dione, 21-acetate
11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione 21-acetate
17-|A-oC>>uAE currencyOEcThornI feminineOOEao yen
17-alpha-Hydroxycorticosterone acetate
17-Hydroxycorticosterone 21-acetate
17-Hydroxycorticosterone acetate
17-Hydroxycorticosterone-21-acetate
17-Hydroxycorticosterone, 21-acetate
17-oC>>uAE currencyOEcThornI feminine 21-OOEao yen
17.alpha.-Hydrocorticosterone-21-acetate
17.alpha.-Hydroxycorticosterone acetate
2-((8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate
2-[(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl]-2-oxoethyl acetate
2-[(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-2,15-dimethyl-5-oxotetracyclo[8.7.0.0(2),?.0(1)(1),(1)?]heptadec-6-en-14-yl]-2-oxoethyl acetate
2-[2-(cyclopentylamino)-2-oxoethyl]-N-(4-methylbenzyl)-3-oxo-2,3-dihydro[1,2,4]triazolo[4,3-a]pyridine-6-carboxamide
21-Acetoxy-11-beta,17-alpha-dihydroxypregn-4-ene-3,20-dione
21-Acetoxy-11.beta.,17-dihydroxypregn-4-en-3,20-dione
21-Acetoxy-11.beta.,17-dihydroxypregn-4-ene-3,20-dione
21-Acetoxy-11.beta.,17.alpha.-dihydroxypregn-4-ene-3,20-dione
21-Acetoxy-11.beta.17.alpha.-dihydroxypregn-4-ene-3,20-dione
21-Acetoxy-4-pregnene-11beta,17alpha-diol-3,20-dione
21-O-acetylcortisol
21-OOo poundNo>>u-4-OEthI(c)-11|A,17|A- paragraph signthorn (1/4)-3,20- paragraph signthornI feminine
2585-EP2277866A1
2585-EP2280008A2
2585-EP2289483A1
2585-EP2292604A2
2585-EP2295401A2
2585-EP2298732A1
2585-EP2301913A1
2585-EP2301914A1
2585-EP2305257A1
2585-EP2305667A2
2585-EP2305682A1
2585-EP2308843A1
2585-EP2308879A1
2585-EP2311815A1
2585-EP2314574A1
2585-EP2316824A1
3X7931PO74
4-OEthI(c)-11|A,17|A,21-Ey (1/4)-3,20- paragraph signthornI feminine 21-OOEao yen
4-Pregnene-11beta,17alpha,21-triol-3,20-dione 21-acetate
42016-02-4
50-03-3
60620-33-9
A827940
AB0010488
AB00430024-17
Abbocort
AC1L1L1K
Acepolcort-H
Acetate-AS
acetic acid [2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] ester
Aceto-cort
ACon0_000402
ACon1_000363
AI3-26389
AJ-46416
AKOS015919714
Ala scalp
ALEXXDVDDISNDU-JZYPGELDSA-N
Alfacorton
Allocort
AN-24363
Anusol-HC
API0002946
Bacicoline
Bacicoline (Salt/Mix)
Bambicort
Berlison
Berlison F
Biocortar
BR-51737
BRD-K11612998-001-01-6
C02821
C23H32O6
CaldeCORT
Carmol HC
Carmol-HC (TN)
CCG-220891
CHEBI:17609
CHEMBL1091
Chemysone
Chloromycetin Hydrocortisone Ophthalmic
Chloromycetin Hydrocortisone Ophthalmic (Salt/Mix)
Clear-Aid
Clear-Aid (Salt/Mix)
Colifoam
Collusul-HC
Colofoam
Coly-Mycin S Otic (Salt/Mix)
component of Neo-Cortef
component of Protef
Compound F acetate
Cordes
Cortacream
Cortaid
Cortef acetate
Cortell
Cortes
Corti
Corti Selbe
Cortic
Corticaine Cream
Corticaine Cream (Salt/Mix)
Corticosterone, 17-hydroxy-, 21-acetate
Cortiderm
Cortidro
Cortifoam (TN)
Cortiform
Cortimycine
Cortioftal
Cortisol 21-acetate
Cortisol acetate
Cortisol- 21-acetate
Cortisol, 21-acetate
Cortisporin Cream
Cortisporin Cream (Salt/Mix)
Cortril acetate
Cortril acetate-AS
Crema transcutan
CS-4792
CTK6A2424
D00165
Derminovag
Dermosa hidrocortisona
Ebenol
EC 200-004-4
Efcolin
Efzem
EINECS 200-004-4
Ekzemsalbe F
Epifoam
Epifoam (Salt/Mix)
Eye-Cort
Fenitral
Glycocortison
HA
Hc45
Hipokort
HMS2090M06
HMS2230H03
HMS2235G21
HMS3259E05
HMS3714D04
HY-B1183
Hycor Eye Oitment
Hycortole acetate
Hyderm
Hydrin-2
Hydriocort von ct
Hydrison
Hydro-Adreson [inj.]
Hydrocortisat
Hydrocortison
Hydrocortison Streuli
Hydrocortisone (acetate)
Hydrocortisone 21-acetate
Hydrocortisone 21-acetate, >=98% (HPLC)
Hydrocortisone 21-acetate, Antibiotic for Culture Media Use Only
Hydrocortisone 21-acetate, meets USP testing specifications
Hydrocortisone 21-acetate, Sigma Reference Standard
Hydrocortisone 21-acetate, tested according to Ph.Eur.
Hydrocortisone 21-acetate, VETRANAL(TM), analytical standard
Hydrocortisone acetate (JP17/USP)
Hydrocortisone acetate [USAN:BAN:JAN]
Hydrocortisone acetate [USP:BAN:JAN]
Hydrocortisone acetate for peak identification, European Pharmacopoeia (EP) Reference Standard
Hydrocortisone acetate, British Pharmacopoeia (BP) Reference Standard
Hydrocortisone acetate, European Pharmacopoeia (EP) Reference Standard
Hydrocortisone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material
Hydrocortisone acetate, United States Pharmacopeia (USP) Reference Standard
Hydrocortisone-21-acetate
Hydrocortisoni acetas
Hydrocortone acetate
Hydrosone
Hydrosone-A
Hydroxycorticosterone acetate
Hysone-A
Idrocort
Idrocortigamma
Idrocortisone Acetano
Iracetisone
Isopto-Hydrocortisone
Korti
KS-1070
Lanacort
Latimit
Lenirit
Lidamantle-HC (Salt/Mix)
LMST02030093
LS-54995
Mantadil
Mantadil (Salt/Mix)
MCULE-1716653767
Medithane
MEGxm0_000464
MFCD00037714
MLS000069734
MLS001076491
MLS002207225
MLS002548890
MolPort-001-740-055
Mysone
NC00457
NCGC00021277-03
Neo-Cortef (Salt/Mix)
Neobacimyx (Salt/Mix)
NSC 741
NSC-741
NSC741
Oft Cusi Hidrocortisona
Opera_ID_774
Ophticor
Pabracort
Pannocort
Paro
Posterine Corte
Pregn-4-ene-3, 11.beta.,17,21-trihydroxy-, 21-acetate
Pregn-4-ene-3, 21-(acetyloxy)-11,17-dihydroxy-, (11.beta.)-
Pregn-4-ene-3,20-dione, 11-beta,17,21-trihydroxy-, 21-acetate
Pregn-4-ene-3,20-dione, 11.beta.,17,21-trihydroxy-, 21-acetate
Pregn-4-ene-3,20-dione, 11beta,17,21-trihydroxy-, 21-acetate
Pregn-4-ene-3,20-dione, 21-(acetoxy)-11,17-dihydroxy-, (11-.beta.)-
Pregn-4-ene-3,20-dione, 21-(acetoxy)-11,17-dihydroxy-, (11-beta)-
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11.beta.)-
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11beta)-
Proctocream-HC (Salt/Mix)
ProctoFoam-HC (Salt/Mix)
Protef (Salt/Mix)
Q-201212
Resicort
S-2682
Sagittacortin
Sanadermil
SC-20108
SCHEMBL7419
Siguent Hycor
Sintotrat
SMR000058178
SMR000653536
Soenol Hydrocortison
Squibb-HC
SR-01000000170
SR-01000000170-3
ST2413116
Supralef
Terra-Cortril (Salt/Mix)
U-CORT
UNII-3X7931PO74
Urecortyn
Velopural
WLN: L E5 B666 OV MUTJ A CQ E FV1OV1 FQ -B&ACEF
Wycort
xEaCa>> inverted question markEmicroAEE
Z802671478
ZINC3875333

US Patents and Regulatory Information for HYDROCORTISONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cenci HYDROCORTISONE ACETATE hydrocortisone acetate CREAM;TOPICAL 080419-001 Jan 25, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 009637-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm HYDROCORTISONE ACETATE hydrocortisone acetate CREAM;TOPICAL 086050-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 083759-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bel Mar HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 083739-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Genus Lifesciences HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 089440-001 May 17, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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