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Last Updated: November 4, 2024

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. Twenty-nine suppliers are listed for this compound.

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
State University of New York - Downstate Medical CenterPhase 1/Phase 2
Jacobio Pharmaceuticals Co., Ltd.Phase 1
Loxo Oncology, Inc.Phase 1

See all DIGOXIN clinical trials

Pharmacology for DIGOXIN
Drug ClassCardiac Glycoside
Medical Subject Heading (MeSH) Categories for DIGOXIN
Anatomical Therapeutic Chemical (ATC) Classes for DIGOXIN

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
Concordia LANOXIN digoxin TABLET;ORAL 020405-005 Sep 30, 1997 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novitium Pharma DIGOXIN digoxin TABLET;ORAL 215307-003 Aug 25, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Wyeth Ayerst DIGOXIN digoxin INJECTABLE;INJECTION 084386-001 Approved Prior to Jan 1, 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

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

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