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Spironolactone - Generic Drug Details

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

Spironolactone is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Gd Searle Llc, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma Ltd, Casi Pharms Inc, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-five NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for spironolactone. Forty-seven suppliers are listed for this compound.

Summary for spironolactone

US Patents:	1
Tradenames:	3
Applicants:	22
NDAs:	25
Drug Master File Entries:	16
Suppliers / Packagers:	47
Bulk Api Vendors:	60
Clinical Trials:	178
Patent Applications:	6,255
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for spironolactone
DailyMed Link:	spironolactone at DailyMed

Pharmacology for spironolactone

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for spironolactone

Diuretics
Mineralocorticoid Receptor Antagonists

Synonyms for spironolactone

(1'S,2R,2'R,9'R,10'R,11'S,15'S)-9'-(acetylsulfanyl)-2',15'-dimethylspiro[oxolane-2,14'-tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan]-6'-ene-5,5'-dione
(1'S,2R,2'R,9'R,10'R,11'S,15'S)-9'-(acetylsulfanyl)-2',15'-dimethylspiro[oxolane-2,14'-tetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadecan]-6'-ene-5,5'-dione
(1'S,2R,2'R,9'R,10'R,11'S,15'S)-9'-(ACETYLSULFANYL)-2',15'-DIMETHYLSPIRO[OXOLANE-2,14'-TETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECAN]-6'-ENE-5,5'-DIONE
(7?,17?)-7-(Acetylthio)-17-hydroxy-3-oxopregn-4-ene-21-carboxylic acid ?-lactone
082S250
1050678-93-7
17-alpha-Pregn-4-ene-21-carboxylic acid, 17-hydroxy-7-alpha-mercapto-3-oxo-, gamma-lactone acetate
17-HYDROXY-7ALPHA-MERCAPTO-3-OXO-17ALPHA-PREGN-4-ENE-21- CARBOXYLIC ACID, GAMMA-LACTONE ACETATE
17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic acid, gamma-lactone acetate
17.alpha.-Pregn-4-ene-21-carboxylic acid, .gamma.-lactone acetate
17.alpha.-Pregn-4-ene-21-carboxylic acid, .gamma.-lactone, acetate
17alpha-Pregn-4-ene-21-carboxylic acid, 17-hydroxy-7alpha-mercapto-3-oxo-, gamma-lactone, acetate
2'',15''-dimethyl-5,5''-dioxo-(9''R)-spiro[tetrahydrofuran-2,14''-tetracyclo[8.7.0.02,7.011,15]heptadec-6''-ene]-9-yl ethanethioate
2'',15''-dimethyl-5,5''-dioxospiro[tetrahydrofuran-2,14''-tetracyclo[8.7.0.02,7.011,15]heptadec-6''-ene]-9-yl ethanethioate
2'',15''-dimethyl-5,5''-dioxospiro[tetrahydrofuran-2,14''-tetracyclo[8.7.0.02,7.011,15]heptadec-6''-ene]-9-yl ethanethioate(Spiranolactone)
27O7W4T232
2oax
3-(3-Keto-7-alpha-acetylthio-17-beta-hydroxy-4-androsten-17-alpha-yl)propionic acid lactone
3-(3-Keto-7.alpha.-acetylthio-17.beta.-hydroxy-4-androsten-17.alpha.-yl)propionic acid lactone
3'-(3-Oxo-7-alpha-acetylthio-17-beta-hydroxyandrost-4-en-17-beta-yl)propionic acid lactone
3vhu
4-18-00-01601 (Beilstein Handbook Reference)
4-Pregnen-21-oic acid-17\|A-ol-3-one-7\|A-thiol \|A-lactone 7-acetate; 7\|A-(Acetylthio)-17\|A-hydroxy-3-oxopregn-4-ene-21-carboxylic acid \|A-lactone
4-Pregnen-21-oic acid-17alpha-ol-3-one-7alpha-thiol gamma-lactone 7-acetate
496916-40-6
52-01-7
7-.alpha.-(acetylthio)-17-.alpha.-hydroxy-3-oxopregn-4-ene-21-carboxylic acid, .gamma.-lactone
7-alpha-(acetylthio)-17-alpha-hydroxy-3-oxopregn-4-ene-21-carboxylic acid, gamma-lactone
7-alpha-(acetylthio)-17-alpha-hydroxy-3-oxopregn-4-ene-21-carboxylic acid, gamma-lactone (9CI)
7-alpha-Acetylthio-3-oxo-17-alpha-pregn-4-ene-21,17-beta-carbolactone
7080-EP2269989A1
7080-EP2270011A1
7080-EP2272841A1
7080-EP2295406A1
7080-EP2298772A1
7080-EP2298776A1
7080-EP2301936A1
7080-EP2308562A2
7080-EP2308839A1
7alpha-(acetylsulfanyl)-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone
7alpha-(Acetylthio)-17alpha-hydroxy-3-oxopregn-4-ene-21-carboxylic acid gamma-lactone
AB00513806
AB01275520_02
AB01275520-01
AB1009415
Abbolactone
AC-4214
AC1L1L8Q
Acelat
ACT02596
AKOS015896401
Aldace
Aldactazide
Aldactazide (TN)
Aldactide
Aldactone
Aldactone (TN)
Aldactone A
Alderon
Aldopur
Almatol
Alphapharm Brand of Spironolactone
Alpharma Brand of Spironolactone
Alter Brand of Spironolactone
Altex
Aquareduct
Ashbourne Brand of Spironolactone
Azupharma Brand of Spironolactone
BC204094
BDBM50228080
Berlactone
Berlactone (TN)
betapharm Brand of Spironolactone
BIDD:PXR0071
BPBio1_000194
BRD-K90027355-001-03-4
BRN 0057767
BSPBio_000176
C07310
C24H32O4S
Cardel Brand of Spironolactone
Carospir
CAS-52-01-7
CCG-220128
CHEBI:9241
CHEMBL1393
CPD000471892
CS-2670
ct Arzneimittel Brand of Spironolactone
ct-Arzneimittel Brand of Spironolactone
D00443
D0EP0C
DB00421
Deverol
Dexo Brand of Spironolactone
Diatense
Diatensec
Dira
DSSTox_CID_14186
DSSTox_GSID_34186
DSSTox_RID_79120
DTXSID6034186
Duraspiron
EINECS 200-133-6
EN300-123035
Espironolactona
Espironolactona [INN-Spanish]
Espironolactona Alter
Espironolactona Mundogen
Euteberol
Flumach
Frumikal
Generosan Brand of Spironolactone
GTPL2875
H490
HMS1568I18
HMS2090N21
HMS2095I18
HMS2236E06
HMS3259G11
Hormosan Brand of Spironolactone
HSDB 3184
HY-B0561
I06-1970
Jenapharm Brand of Spironolactone
Jenaspiron
KS-00000FA6
KS-5234
Lacalmin
Lacdene
Laractone
LS-118614
LT00772287
LXMSZDCAJNLERA-ZHYRCANASA-N
Mayoly-Spindler Brand of Spironolactone
MCULE-4394091100
Melarcon
Merck dura Brand of Spironolactone
MFCD00082250
MLS001074672
MLS001333253
MLS001333254
MLS002153245
MLS002207058
MLS002548846
MolPort-033-355-721
Mundogen Brand of Spironolactone
NC00482
NCGC00015948-02
NCGC00164397-01
NCGC00164397-02
NCGC00164397-03
NCGC00164397-05
NCGC00255229-01
Nefurofan
Novo Spiroton
Novo-Spiroton
Novo-Spiroton (TN)
Novopharm Brand of Spironolactone
NovoSpiroton
NSC 150399
NSC-150399
NSC150399
Osyrol
Pfizer Brand of Spironolactone
Pharmafrid Brand of Spironolactone
PL000361
Practon
Pregn-4-ene-21-carboxylic acid, .gamma.-lactone, (7.alpha.,17.alpha.)-
Pregn-4-ene-21-carboxylic acid, 7-(acetylthio)-17-hydroxy-3-oxo-, gamma-lactone, (7alpha,17alpha)-
Prestwick0_000128
Prestwick1_000128
Prestwick2_000128
Prestwick3_000128
Q-201737
quimolactona
Roche Brand of Spironolactone
S-((7R,8R,9S,10R,13S,14S,17R)-10,13-dimethyl-3,5'-dioxo-1,2,3,4',5',6,7,8,9,10,11,12,13,14,15,16-hexadecahydro-3'H-spiro[cyclopenta[a]phenanthrene-17,2'-furan]-7-yl) ethanethioate
S-(2''R,7R,8R,9S,10R,13S,14S)-10,13-dimethyl-3,5''-dioxo-1,2,3,4'',5'',6,7,8,9,10,11,12,13,14,15,16-hexadecahydro-3''H-spiro[cyclopenta[a]phenanthrene-17,2''-furan]-7-yl ethanethioate
S-[(7R,8R,9S,10R,13S,14S,17R)-10,13-dimethyl-3,5'-dioxo-1,2,3,4',5',6,7,8,9,10,11,12,13,14,15,16-hexadecahydro-3'H-spiro[cyclopenta[a]phenanthrene-17,2'-furan]-7-yl] ethanethioate
S-[(7R,8R,9S,10R,13S,14S,17R)-10,13-dimethyl-3,5'-dioxospiro[2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-17,2'-oxolane]-7-yl] ethanethioate
S0260
s4054
Sagisal
SC 15983
SC 9420
SC-15112
SC-9420
SC9420
SCHEMBL20939
Searle Brand of Spironolactone
Sincomen
SMR000471892
SNL
SPBio_002115
Spiractin
Spiractin (TN)
Spiranolactone
Spiresis
Spiretic
Spiridon
Spiro L.U.T.
spiro von ct
Spiro-Tablinen
Spiro(17H-cyclopenta(a)phenanthrene-17,2'(5'H)-furan), pregn-4-ene-21-carboxylic acid deriv
Spiro(17H-cyclopenta(a)phenauthrene-17,2'-(3'H)-furan)
Spiro[17H-cyclopenta[a]phenauthrene-17,2'-(3'H)-furan]
Spirobeta
Spiroctan
Spiroctanie
Spiroderm
Spirogamma
Spirolactone
Spirolakton
Spirolang
Spirolone
Spirone
Spirono Isis
Spirono-Isis
Spironocompren
Spironolactone (JP15/USP/INN)
Spironolactone (JP17/USP/INN)
Spironolactone [BAN:INN:JAN]
Spironolactone [INN:BAN:JAN]
Spironolactone [USP:INN:BAN:JAN]
Spironolactone 1.0 mg/ml in Acetonitrile
Spironolactone A
Spironolactone for system suitability, European Pharmacopoeia (EP) Reference Standard
Spironolactone, 97.0-103.0%
Spironolactone, European Pharmacopoeia (EP) Reference Standard
Spironolactone, United States Pharmacopeia (USP) Reference Standard
Spironolactonum
Spironolactonum [INN-Latin]
spironolattone
Spironolattone [DCIT]
Spironone
Spirospare
spirotone
Spirotone (TN)
Sprioderm
SR-05000000452
SR-05000000452-2
Supra-puren
Suracton
Tox21_113047
Tox21_302154
UNII-27O7W4T232
Uractone
Urusonin
Veroshpiron
Verospiron
Verospiron (TN)
Verospirone
Verospirone Opianin
von ct, spiro
WLN: L E5 B666 FX OV MUTJ A1 E1 KSV1 F-& CT5VOXTJ
Worwag Brand of Spironolactone
Xenalon
Z1551900341
ZINC3861599

US Patents and Regulatory Information for spironolactone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	SPIRONOLACTONE	spironolactone	TABLET;ORAL	202187-001	Mar 6, 2014	AB	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Warner Chilcott	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087952-001	Nov 18, 1982		DISCN	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Amneal Pharms	SPIRONOLACTONE	spironolactone	TABLET;ORAL	091426-002	Jul 2, 2010	AB	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Accord Hlthcare	SPIRONOLACTONE	spironolactone	TABLET;ORAL	203512-003	Sep 19, 2016	AB	RX	No	No	➤ 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

International Patents for spironolactone

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Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017075463	➤ Try a Free Trial
Country	Document Number	Estimated Expiration