NEXTERONE Drug Patent Profile

When do Nexterone patents expire, and when can generic versions of Nexterone launch?

Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in thirteen countries.

The generic ingredient in NEXTERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexterone

A generic version of NEXTERONE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30^th, 1998.

Summary for NEXTERONE

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	3
Patent Applications:	793
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEXTERONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXTERONE
What excipients (inactive ingredients) are in NEXTERONE?	NEXTERONE excipients list
DailyMed Link:	NEXTERONE at DailyMed

See drug prices for NEXTERONE

Recent Clinical Trials for NEXTERONE

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

Sponsor	Phase
University of Calgary	Phase 4
National Institute on Drug Abuse (NIDA)	Phase 4
Rockefeller University	Phase 4

See all NEXTERONE clinical trials

Pharmacology for NEXTERONE

Drug Class	Antiarrhythmic
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NEXTERONE

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

US Patents and Regulatory Information for NEXTERONE

NEXTERONE is protected by one US patents.

Patents protecting NEXTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008		DISCN	Yes	No			Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes			Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes			Y

Expired US Patents for NEXTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010

International Patents for NEXTERONE

See the table below for patents covering NEXTERONE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2771879	COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Spain	2176206
Japan	2005530744
Japan	2011116776	FORMULATION CONTAINING AMIODARONE AND SULFOALKYL ETHER CYCLODEXTRIN
European Patent Office	2402008	Formulations contenant de l'amiodarone et de la cyclodextrine d'éther de sulfoalkyle (Formulations containing amiodarone and sulfoalkyl ether cyclodextrin)