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Last Updated: August 6, 2020

DrugPatentWatch Database Preview

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-one 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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolPhase 2
Maimonides Medical CenterPhase 2
Jiangsu HengRui Medicine Co., Ltd.Phase 1

See all digoxin clinical trials

Pharmacology for digoxin
Medical Subject Heading (MeSH) Categories 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
Sandoz Inc DIGOXIN digoxin INJECTABLE;INJECTION 040481-001 Aug 21, 2003 AP RX No No   Start Trial   Start Trial   Start Trial
Impax Labs DIGOXIN digoxin TABLET;ORAL 078556-001 Jul 20, 2009 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
>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 018118-002 Jul 26, 1982   Start Trial   Start Trial
Glaxosmithkline Llc LANOXICAPS digoxin CAPSULE;ORAL 018118-004 Sep 24, 1984   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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Medtronic
Dow
Johnson and Johnson
Merck

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