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, Amici, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Covis, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, 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:	87
Clinical Trials:	233
Patent Applications:	6,794
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
State University of New York - Downstate Medical Center	Phase 1/Phase 2
Jacobio Pharmaceuticals Co., Ltd.	Phase 1
Loxo Oncology, Inc.	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

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

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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
Hospira	DIGOXIN	digoxin	INJECTABLE;INJECTION	040093-001	May 16, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DIGOXIN	digoxin	INJECTABLE;INJECTION	083391-001	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DIGOXIN	digoxin	ELIXIR;ORAL	021648-001	Aug 26, 2004	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	DIGOXIN	digoxin	INJECTABLE;INJECTION	083217-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	018118-002	Jul 26, 1982	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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