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, 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

Sponsor	Phase
St. Jude Medical	N/A
Abbott Medical Devices	N/A
Ball Memorial Hospital	N/A

See all ibutilide fumarate clinical trials

Pharmacology for ibutilide fumarate

Drug Class	Antiarrhythmic

Anatomical Therapeutic Chemical (ATC) Classes for ibutilide fumarate

C01BD	Antiarrhythmics, class III
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for ibutilide fumarate

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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
Mylan Institutional	IBUTILIDE FUMARATE	ibutilide fumarate	INJECTABLE;INJECTION	090643-001	Jan 11, 2010	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
>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 ibutilide fumarate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491-001	Dec 28, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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