Last Updated: September 28, 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 30th, 1998.

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Questions you can ask:
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Summary 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.

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-002 Nov 16, 2010 RX Yes Yes ⤷  Start Trial ⤷  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.

Country Patent Number Title Estimated Expiration
Austria 170742 ⤷  Start Trial
Austria 217325 ⤷  Start Trial
Australia 4779993 ⤷  Start Trial
Australia 646020 ⤷  Start Trial
Australia 672814 ⤷  Start Trial
Australia 7236491 ⤷  Start Trial
Canada 2074186 DERIVES DE CYCLODEXTRINES PLUS SOLUBLES DANS L'EAU ET LEUR UTILISATION (DERIVATIVES OF CYCLODEXTRINS EXHIBITING ENHANCED AQUEOUS SOLUBILITY AND THE USE THEREOF) ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

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