Digoxin - Generic Drug Details

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, Amici, Hikma, Novitium Pharma, Abraxis Pharm, Hospira, Sandoz Inc, West-ward Pharms Int, Wyeth Ayerst, Covis, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Rising, Stevens J, Sun Pharm Inds Inc, and Concordia, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for digoxin

US Patents:	0
Tradenames:	5
Applicants:	17
NDAs:	20
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	204
Patent Applications:	5,420
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for digoxin
Drug Sales Revenues:	Drug sales revenues for digoxin
What excipients (inactive ingredients) are in digoxin?	digoxin excipients list
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
GCP-unit at Odense University Hospital	N/A
Lars Peter Riber	N/A
Odense University Hospital	N/A

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

Anatomical Therapeutic Chemical (ATC) Classes for digoxin

C01AA	Digitalis glycosides
C01A	CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

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 Intl Pharms	DIGOXIN	digoxin	TABLET;ORAL	077002-002	Oct 30, 2007	AB	RX	No	No
Concordia	LANOXIN	digoxin	TABLET;ORAL	020405-003	Sep 30, 1997		DISCN	Yes	No
Sun Pharm Inds Inc	DIGOXIN	digoxin	TABLET;ORAL	076363-001	Jan 31, 2003	AB	RX	No	No
Hikma Intl Pharms	DIGOXIN	digoxin	TABLET;ORAL	077002-001	Oct 30, 2007	AB	RX	No	No
Concordia	LANOXIN	digoxin	TABLET;ORAL	020405-006	Sep 30, 1997		DISCN	No	No
Rising	DIGOXIN	digoxin	TABLET;ORAL	040282-001	Dec 23, 1999	AB	RX	No	No
Novitium Pharma	DIGOXIN	digoxin	TABLET;ORAL	215307-001	Nov 22, 2021	AB	RX	No	No

Expired US Patents for digoxin

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