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Last Updated: November 21, 2024

IBUTILIDE FUMARATE - Generic Drug Details


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What are the generic 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, Avet Lifesciences, Luitpold, and Mylan Institutional, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for IBUTILIDE FUMARATE
US Patents:0
Tradenames:2
Applicants:4
NDAs:5
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 71
Clinical Trials: 1
Patent Applications: 818
What excipients (inactive ingredients) are in IBUTILIDE FUMARATE?IBUTILIDE FUMARATE excipients list
DailyMed Link:IBUTILIDE FUMARATE at DailyMed
Recent Clinical Trials for IBUTILIDE FUMARATE

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

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

See all IBUTILIDE FUMARATE clinical trials

Pharmacology for IBUTILIDE FUMARATE
Drug ClassAntiarrhythmic
Anatomical Therapeutic Chemical (ATC) Classes for IBUTILIDE FUMARATE

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
Avet Lifesciences IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 204146-001 Apr 1, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Luitpold IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 090240-001 Jan 11, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Institutional IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 090643-001 Jan 11, 2010 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer CORVERT ibutilide fumarate INJECTABLE;INJECTION 020491-001 Dec 28, 1995 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Institutional IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 090924-001 Jan 11, 2010 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

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