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-four 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:	4
Patent Applications:	847
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
OHSU Knight Cancer Institute	Phase 2
University of Calgary	Phase 4
National Institute on Drug Abuse (NIDA)	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

US Patents and Regulatory Information for NEXTERONE

NEXTERONE is protected by one 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	7,635,773		Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes	7,635,773		Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes	7,635,773		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	022325-003	Nov 16, 2010	6,869,939
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008	5,134,127
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010	6,869,939

International Patents for NEXTERONE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2005530744
World Intellectual Property Organization (WIPO)	9402518
Russian Federation	2113442	PURIFIED DERIVATIVES OF SULFOALKYL ETHERS OF CYCLODEXTRINE OR THEIR MIXTURE, CLATRATE COMPLEX OF CYCLODEXTRINE DERIVATIVES WITH MEDICINAL, AND PHARMACEUTICAL COMPOSITION

NEXTERONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nexterone

Introduction

Nexterone, a novel formulation of the antiarrhythmic agent amiodarone, was approved by the FDA in 2009 for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia. Here, we delve into the market dynamics and financial trajectory of Nexterone, highlighting its commercialization, market impact, and financial performance.

FDA Approval and Initial Market Entry

Nexterone, developed by Prism Pharmaceuticals (now part of Baxter Healthcare Corporation), received FDA approval on January 5, 2009. This approval marked a significant milestone for the company, validating its accelerated development model which brought the product from licensing to FDA clearance in under three years[4].

Commercialization Strategy

Prism Pharmaceuticals intended to commercialize Nexterone in the US through a combination of self-commercialization and partnerships with companies well-positioned in the hospital marketplace. The company also sought to license the ex-US worldwide rights. The commercial strategy included targeting health-system pharmacists, who are key decision-makers in medication safety improvements in hospitals[4].

Market Opportunity

Nexterone addressed a critical need in the treatment of life-threatening ventricular fibrillation and ventricular tachycardia. The product's unique formulation, free from cosolvents like polysorbate 80 and benzyl alcohol, offered improved compatibility and stability, making it a preferable option over traditional amiodarone IV formulations. This differentiation was expected to drive rapid conversion from generic amiodarone IV and potentially render conventional formulations obsolete[4].

Financial Milestones

The FDA approval of Nexterone triggered significant financial milestones for Prism Pharmaceuticals. This included a second $10 million milestone payment from Paul Capital, part of a long-range financing agreement established in 2006. This non-dilutive capital was crucial for supporting the product through the NDA review and commercial launch phases[4].

Revenue and Growth Potential

While specific revenue figures for Nexterone are not detailed in the sources, the product's potential for significant revenue generation was high. The approval and subsequent commercialization were expected to contribute substantially to Prism Pharmaceuticals' financial performance. The company's strategy to offer premixed, ready-to-use configurations further enhanced the product's market appeal and potential for rapid adoption[4].

Royalty Structure

Nexterone, as part of Ligand Pharmaceuticals' portfolio (following the acquisition or partnership with Prism Pharmaceuticals), would likely generate royalties. Ligand Pharmaceuticals typically receives royalties on the sales of its partnered products, although the specific royalty rate for Nexterone is not specified in the available sources. However, given Ligand's model, it is reasonable to assume that Nexterone would contribute to Ligand's royalty revenue stream[2][3].

Competitive Landscape

In the antiarrhythmic market, Nexterone faced competition from existing amiodarone formulations but had a competitive edge due to its novel formulation and improved stability profile. The product's ability to be formulated in premixed, ready-to-use configurations was a significant differentiator, making it more convenient and safer for use in clinical settings[4].

Operational and Manufacturing Aspects

Prism Pharmaceuticals collaborated with Baxter Healthcare Corporation to implement a full-scale manufacturing development program for Nexterone. This partnership was crucial for ensuring the product's availability in various configurations, including premixed bags, which were a key focus of the commercial launch strategy[4].

Key Takeaways

• FDA Approval: Nexterone received FDA approval in 2009 for treating ventricular fibrillation and ventricular tachycardia.
• Commercialization: Prism Pharmaceuticals commercialized Nexterone in the US with partners and sought ex-US licensing.
• Market Differentiation: Nexterone's novel formulation offered improved compatibility and stability.
• Financial Milestones: The product triggered significant milestone payments and was expected to contribute to Prism Pharmaceuticals' revenue.
• Royalty Potential: Nexterone likely generated royalties as part of Ligand Pharmaceuticals' portfolio.

FAQs

What is Nexterone used for?

Nexterone is used for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia.

Who developed Nexterone?

Nexterone was developed by Prism Pharmaceuticals, which is now associated with Baxter Healthcare Corporation.

What makes Nexterone unique?

Nexterone is a cosolvent-free formulation of amiodarone, offering improved compatibility and stability compared to traditional amiodarone IV formulations.

How was Nexterone commercialized?

Nexterone was commercialized in the US through a combination of self-commercialization and partnerships, with a focus on targeting health-system pharmacists.

What financial milestones were associated with Nexterone's approval?

The FDA approval of Nexterone triggered a $10 million milestone payment from Paul Capital as part of a long-range financing agreement.

Sources

1. Ligand Pharmaceuticals Corporate Presentation - July 2024
2. Ligand Pharmaceuticals First Quarter 2024 Financial Results
3. Ligand Pharmaceuticals Second Quarter 2024 Financial Results
4. Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) - January 5, 2009