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Last Updated: March 19, 2024

Ibutilide fumarate - Generic Drug Details


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What are the generic drug sources for ibutilide fumarate and what is the scope of patent protection?

Ibutilide fumarate is the generic ingredient in two branded drugs marketed by Pfizer, Luitpold, and Mylan Institutional, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for ibutilide fumarate. Two suppliers are listed for this compound.

Summary for ibutilide fumarate
Recent Clinical Trials for ibutilide fumarate

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

SponsorPhase
St. Jude MedicalN/A
Abbott Medical DevicesN/A
Ball Memorial HospitalN/A

See all ibutilide fumarate clinical trials

Pharmacology for ibutilide fumarate
Drug ClassAntiarrhythmic

US Patents and Regulatory Information for ibutilide fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Luitpold IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 090240-001 Jan 11, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer CORVERT ibutilide fumarate INJECTABLE;INJECTION 020491-001 Dec 28, 1995 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 090924-001 Jan 11, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 090643-001 Jan 11, 2010 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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