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Last Updated: April 8, 2020

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DIGOXIN Drug Profile


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When do Digoxin patents expire, and what generic alternatives are available?

Digoxin is a drug marketed by Hikma, Vistapharm, Abraxis Pharm, Hospira, Sandoz Inc, West-ward Pharms Int, Wyeth Ayerst, Hikma Intl Pharms, Impax Labs, Mylan Pharms Inc, Stevens J, and Sun Pharm Inds Inc. and is included in fourteen NDAs.

The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the digoxin profile page.

US ANDA Litigation and Generic Entry Outlook for Digoxin

A generic version of DIGOXIN was approved as digoxin by MYLAN PHARMS INC on December 23rd, 1999.

  Start Trial

Drug patent expirations by year for DIGOXIN
Drug Prices for DIGOXIN

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Drug Sales Revenue Trends for DIGOXIN

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Recent Clinical Trials for DIGOXIN

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

SponsorPhase
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolPhase 2
Janssen Research & Development, LLCPhase 1
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationPhase 1

See all DIGOXIN clinical trials

Pharmacology for DIGOXIN
Medical Subject Heading (MeSH) Categories for DIGOXIN
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma DIGOXIN digoxin ELIXIR;ORAL 021648-001 Aug 26, 2004 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc DIGOXIN digoxin TABLET;ORAL 076363-002 Jan 31, 2003 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
Hospira DIGOXIN digoxin INJECTABLE;INJECTION 040093-001 May 16, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs DIGOXIN digoxin TABLET;ORAL 078556-002 Jul 20, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Wyeth Ayerst DIGOXIN digoxin INJECTABLE;INJECTION 084386-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira DIGOXIN PEDIATRIC digoxin INJECTABLE;INJECTION 040092-001 Apr 25, 1996 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
Colorcon
Baxter

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