Last Updated: November 13, 2026

NEXTERONE Drug Patent Profile

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When do Nexterone patents expire, and what generic alternatives are available?

Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NEXTERONE is amiodarone hydrochloride. Thirty-three 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.

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Summary for NEXTERONE

US Patents:	6
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXTERONE

Paragraph IV (Patent) Challenges for NEXTERONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXTERONE	Injection	amiodarone hydrochloride	150 mg/100 mL	022325	1	2025-06-24

US Patents and Regulatory Information for NEXTERONE

NEXTERONE is protected by six US patents.

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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
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008		DISCN	Yes	No	7,635,773	⤷ Start Trial	Y			⤷ Start Trial
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes	9,750,822	⤷ Start Trial	Y			⤷ Start Trial
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes	9,493,582	⤷ Start Trial	Y			⤷ Start Trial
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes	7,635,773	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for NEXTERONE

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

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Country	Patent Number	Title	Estimated Expiration
Austria	170742		⤷ Start Trial
Austria	217325		⤷ Start Trial
Australia	4779993		⤷ Start Trial
Australia	646020		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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