Digoxin - Generic Drug Details

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What are the generic sources for digoxin and what is the scope of freedom to operate?

Digoxin is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Hikma, Vistapharm, Abraxis Pharm, Hospira, Sandoz Inc, West-ward Pharms Int, Wyeth Ayerst, Covis Pharma Bv, Hikma Intl Pharms, Impax Labs, Mylan Pharms Inc, Stevens J, Sun Pharm Inds Inc, and Concordia, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for digoxin. Thirty-five suppliers are listed for this compound.

Summary for digoxin

US Patents:	0
Tradenames:	5
Applicants:	15
NDAs:	17
Drug Master File Entries:	10
Suppliers / Packagers:	35
Bulk Api Vendors:	65
Clinical Trials:	171
Patent Applications:	7,713
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for digoxin
Drug Sales Revenues:	Drug sales revenues for digoxin
DailyMed Link:	digoxin at DailyMed

See drug prices for digoxin

See drug sales revenues for digoxin

Recent Clinical Trials for digoxin

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

Sponsor	Phase
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Phase 2
Janssen Research & Development, LLC	Phase 1
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation	Phase 1

See all digoxin clinical trials

Pharmacology for digoxin

Drug Class	Cardiac Glycoside

Medical Subject Heading (MeSH) Categories for digoxin

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Synonyms for digoxin

(3beta,5beta,12beta)-3-((O-2,6-Dideoxy-beta-D-ribo-hexapyranosyl-(1-4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1-4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl)oxy)-12,14-dihydroxycard-20(22)-enolide
(3beta,5beta,12beta)-3-{[2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl]oxy}-12,14-dihydroxycard-20(22)-enolide
[3H]-digoxin
[3H]digoxin
0B9662A7-264E-4ACD-94B2-9E1138C0CA5A
12bet.-Hydroxydigitoxin
12beta-Hydroxydigitoxin
20830-75-5
3-[(3S,5R,8R,9S,10S,12R,13S,14S,17R)-3-[(2R,4S,5S,6R)-5-[(2S,4S,5S,6R)-5-[(2S,4S,5S,6R)-4,5-dihydroxy-6-methyloxan-2-yl]oxy-4-hydroxy-6-methyloxan-2-yl]oxy-4-hydroxy-6-methyloxan-2-yl]oxy-12,14-dihydr
3b0w
3beta-((O-2,6-Dideoxy-beta-D-ribo-hexopyranosyl-(1-4)-O-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1-4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl)oxy)-12beta,14-dihydroxy-5beta-card-20(22)-enolide
3beta,12beta,14-Trihydroxy-5beta,14beta-card-20(22)-enolid-3-tridigitoxosid
4-((1S,2S,5S,11S,15S,7R,10R,14R,16R)-5-{5-[5-((2S,4S,5S,6R)-4,5-dihydroxy-6-me thyl(2H-3,4,5,6-tetrahydropyran-2-yloxy))(4S,5S,2R,6R)-4-hydroxy-6-methyl(2H-3 ,4,5,6-tetrahydropyran-2-yloxy)](4S,5S,2R,
5-18-04-00381 (Beilstein Handbook Reference)
6R)-4-hydroxy-6-methyl(2H-3,4,5,6-te trahydropyran-2-yloxy)}-11,16-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0<2,7>.0 <11,15>]heptadec-14-yl)-5-hydrofuran-2-one
73K4184T59
830D755
A814956
Acygoxin
AKOS015895113
AKOS024283494
AS-13281
B7684
BDBM46355
BIDD:PXR0148
BPBio1_000500
BRD-K23478508-001-03-7
BRN 0077011
BSPBio_000454
C-23516
C06956
C41H64O14
Card-20(22)-enolide, 3-((O-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-O-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl)oxy)-12,14-dihydroxy-, (3beta,5beta,12beta)-
Card-20(22)-enolide, 3-((O-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1-4)-O-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1-4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl)oxy)-12,14-dihydroxy-, (3beta,5beta,12beta)-
Card-20(22)-enolide, 3-((O-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1.fwdarw.4)-O-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1.fwdarw.4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl)oxy)-12,14-dihydroxy-, (3beta,5beta,12beta)-
Card-20(22)-enolide, 3-[[O-2,6-dideoxy-.beta.-D-ribo-hexopyranosyl-(1-->4)-O-2,6-dideoxy-.beta.-D-ribo-hexopyranosyl-(1-->4)-2,6-dideoxy-.beta.-D-ribo-hexopyranosyl]oxy]-12,14-dihydroxy-, (3.beta.,5.beta.,12.beta.)-
Cardigox
Cardiogoxin
Cardioxin
CAS-20830-75-5
CC-26802
CCG-220437
CHEBI:4551
CHEMBL1751
Chloroformic digitalin
cid_2724385
Coragoxine
Cordioxil
CS-4571
D00298
D1828
Davoxin
DB00390
Digacin
Digitek
Digoksyna
Digoksyna [Polish]
Digomal
Digon
Digonix
Digos
Digosin
Digossina
Digossina [DCIT]
Digoxigenin-tridigitoxosid
Digoxigenin-tridigitoxosid [German]
Digoxin (JP17/USP)
Digoxin [USP:INN:BAN:JAN]
Digoxin 1.0 mg/ml in Methanol
Digoxin for peak identification, European Pharmacopoeia (EP) Reference Standard
Digoxin Nativelle
Digoxin Pediatric
Digoxin solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Digoxin-Sandoz
Digoxin-Zori
Digoxin, 95%
Digoxin, analytical standard
Digoxin, certified reference material, TraceCERT(R)
Digoxin, European Pharmacopoeia (EP) Reference Standard
Digoxin, Pharmaceutical Secondary Standard; Certified Reference Material
Digoxin, United States Pharmacopeia (USP) Reference Standard
Digoxina
Digoxina [INN-Spanish]
Digoxina-Sandoz
Digoxine
Digoxine Navtivelle
Digoxinum
Digoxinum [INN-Latin]
Dilanacin
Dimecip
Dixina
Dokim
DSSTox_CID_2934
DSSTox_GSID_22934
DSSTox_RID_76794
DTXSID5022934
Dynamos
EINECS 244-068-1
Epitope ID:122964
Eudigox
Fargoxin
Grexin
GTPL4725
GTPL4726
H797
Hemigoxine Nativelle
HMS1569G16
HMS2096G16
HMS2232G20
HMS3713G16
Homolle's digitalin
HSDB 214
HY-B1049
J-013666
J10027
Lanacordin
Lanacrist
Lanicor
Lanikor
Lanorale
Lanoxicaps
Lanoxicaps (TN)
Lanoxin
Lanoxin (TN)
LANOXIN PEDIATRIC
Lanoxin PG
Lenoxicaps
Lenoxin
Lifusin
LTMHDMANZUZIPE-PUGKRICDSA-N
Mapluxin
MCULE-8165628529
MFCD00003674
MLS000069819
MLS001055371
MLS001076495
Natigoxin
NCGC00090797-01
NCGC00090797-02
NCGC00090797-03
NCGC00090797-04
NCGC00090797-05
NCGC00090797-06
NCGC00090797-07
NCGC00090797-09
NCGC00090797-15
NCGC00257022-01
NCGC00259227-01
Neo-Lanicor
Neodioxanin
Novodigal [inj.]
NSC 95100
NSC-95100
Opera_ID_1134
oxy-10,13-dimethyl-1,2,3,4,5,6,7,8,9,11,12,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]-2H-furan-5-one
Prestwick_170
Prestwick0_000437
Prestwick1_000437
Prestwick2_000437
Prestwick3_000437
Purgoxin
Q422222
REGID_for_CID_2724385
Rougoxin
s4290
Saroxin
SCHEMBL20506
SK-Digoxin
SMR000059217
SMR000653537
SPBio_002393
SR-01000721866
SR-01000721866-3
SR-01000721866-4
ST069334
Tox21_111025
Tox21_201678
Tox21_303050
UNII-73K4184T59
Vanoxin
ZINC242548690
ZX-AFC001295

US Patents and Regulatory Information for digoxin

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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
Impax Labs	DIGOXIN	digoxin	TABLET;ORAL	078556-002	Jul 20, 2009	AB	RX	No	No	Start Trial	Start Trial				Start Trial
West-ward Pharms Int	DIGOXIN	digoxin	INJECTABLE;INJECTION	083391-001	Approved Prior to Jan 1, 1982	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Hikma Intl Pharms	DIGOXIN	digoxin	TABLET;ORAL	077002-001	Oct 30, 2007	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Hikma Intl Pharms	DIGOXIN	digoxin	TABLET;ORAL	077002-002	Oct 30, 2007	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Hikma	DIGOXIN	digoxin	ELIXIR;ORAL	021648-001	Aug 26, 2004	AA	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Vistapharm	DIGOXIN	digoxin	ELIXIR;ORAL	213000-001	Oct 4, 2019	AA	RX	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

Expired US Patents for digoxin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984	Start Trial	Start Trial
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-002	Jul 26, 1982	Start Trial	Start Trial
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982	Start Trial	Start Trial
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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