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Generated: May 21, 2018

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Hydrocortisone butyrate - Generic Drug Details

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

Hydrocortisone butyrate
is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Glenmark Generics, Taro Pharm Inds, Precision Dermat, Yamanouchi, Teligent Pharma Inc, and Taro, and is included in fourteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixty-four drug master file entries for hydrocortisone butyrate. Nine suppliers are listed for this compound.
Pharmacology for hydrocortisone butyrate
Synonyms for hydrocortisone butyrate
(11beta)-11,21-Dihydroxy-17-(1-oxobutoxy)pregn-4-ene-3,20-dione
(1S,10S,11S,15S,17S,2R,14R)-17-hydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl-5-ox otetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-14-yl butanoate
(1S,2R,10S,11S,14R,15S,17S)-17-HYDROXY-14-(2-HYDROXYACETYL)-2,15-DIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-14-YL BUTANOATE
[(8S,9S,10R,11S,13S,14S,17R)-10,13-dimethyl-11-oxidanyl-17-(2-oxidanylethanoyl)-3-oxidanylidene-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate
[(8S,9S,10R,11S,13S,14S,17R)-11-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate
[11-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate
05RMF7YPWN
11-beta,17-alpha,21-Trihydroxy-4-pregnene-3,20-dione 17-alpha-butyrate
11-beta,17-alpha,21-trihydroxy-4-pregnene-3,20-dione17-alpha-butyrate
11|A,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate
11b,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate
11beta,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate
11beta,21-dihydroxy-17alpha-butyryloxy-4-pregnene-3,20-dione
11beta,21-dihydroxy-3,20-dioxopregn-4-en-17-yl butanoate
135467-84-4
13609-67-1
17-O-butyrylcortisol
4CA-0622
609H671
A807026
AB00052341_02
AC-492
AC1L1AHF
AC1L1GE2
ACMC-20mvrv
AJ-47560
AKOS015895443
Alfason
AN-15773
API0005043
AX8134121
BC214764
BSPBio_003158
Bucort
butanoic acid [(8S,9S,10R,11S,13S,14S,17R)-11-hydroxy-17-(2-hydroxy-1-oxoethyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] ester
Butyric acid hydrocortisone
CAS-13609-67-1
CCG-39923
CHEBI:31674
CHEMBL1434261
CHEMBL1683
Cortisol 17-butyrate
CORTISOL, 17-BUTYRATE
CS-4474
CTK0H7965
D01619
DivK1c_000743
DSSTox_CID_25896
DSSTox_GSID_45896
DSSTox_RID_81208
DTXSID4045896
EINECS 237-093-4
Epitope ID:119710
H-17-B
H.17B
HB(sub 17)
hb(sub17)
HMS1922O17
HMS2093C09
HMS2231B16
HMS502F05
HY-B0983
Hycortate
Hydrocortisone 17-butyrate
Hydrocortisone 17alpha-butyrate
Hydrocortisone Butyrate (Hydrocortisone 17-Butyrate)
Hydrocortisone butyrate (JP17/USP)
Hydrocortisone butyrate [USAN:BAN:JAN]
Hydrocortisone butyrate [USAN:USP:BAN:JAN]
Hydrocortisone butyrate, United States Pharmacopeia (USP) Reference Standard
Hydrocortisone-17-butyrate
Hydrocortisone-17alpha-butyrate
I06-0576
IDI1_000743
KBio1_000743
KBio2_002131
KBio2_004699
KBio2_007267
KBio3_002658
KBioGR_001042
KBioSS_002131
Lacoid
Lacoidon
Laticort
Locoid
locoid (TN)
LS-54996
LT00244772
MCULE-5041290339
MFCD00083364
MLS000028716
MLS001076086
MLS002207122
MolPort-003-941-574
NCGC00095037-01
NCGC00159427-02
NCGC00178233-01
NCGC00274077-01
NINDS_000743
NSC-758433
NSC758433
Opera_ID_188
Pharmakon1600-01503273
PL000382
Pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-(1-oxobutoxy)-, (11-beta)-
Pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-(1-oxobutoxy)-, (11beta)-
SBI-0051808.P002
SCHEMBL14936050
SCHEMBL4695
SMR000058859
SPBio_001212
Spectrum_001651
SPECTRUM1503273
Spectrum2_001106
Spectrum3_001589
Spectrum4_000581
Spectrum5_001171
ST075194
Tox21_111397
Tox21_111397_1
UNII-05RMF7YPWN
VA11057
W-108252
ZINC34779372
ZINC3977794

US Patents and Regulatory Information for hydrocortisone butyrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 076654-001 Aug 3, 2005 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Precision Dermat LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019116-001 Feb 25, 1987 AT RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Mid Atlantic HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 205134-001 Dec 8, 2017 AB2 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Precision Dermat LOCOID hydrocortisone butyrate CREAM;TOPICAL 018514-001 Mar 31, 1982 AB1 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Non-Orange Book US Patents for hydrocortisone butyrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,389,502 Stabilized steroid composition and method for its preparation ➤ Try a Free Trial
8,546,364 Stabilized steroid composition and method for its preparation ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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UBS
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.