NATRECOR Drug Patent Profile

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

Natrecor is a drug marketed by Scios Llc and is included in one NDA.

The generic ingredient in NATRECOR is nesiritide. There are two drug master file entries for this compound. Additional details are available on the nesiritide profile page.

Summary for NATRECOR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	33
Patent Applications:	3,497
Drug Prices:	Drug price information for NATRECOR
DailyMed Link:	NATRECOR at DailyMed

See drug prices for NATRECOR

Recent Clinical Trials for NATRECOR

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

Sponsor	Phase
Virginia Commonwealth University	Phase 4
John C Burnett	Phase 1/Phase 2
National Institutes of Health (NIH)	Phase 1/Phase 2

See all NATRECOR clinical trials

US Patents and Regulatory Information for NATRECOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scios Llc	NATRECOR	nesiritide	FOR SOLUTION;INTRAVENOUS	020920-001	Aug 10, 2001		DISCN	Yes	No

Expired US Patents for NATRECOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Scios Llc	NATRECOR	nesiritide	FOR SOLUTION;INTRAVENOUS	020920-001	Aug 10, 2001	5,114,923
Scios Llc	NATRECOR	nesiritide	FOR SOLUTION;INTRAVENOUS	020920-001	Aug 10, 2001	6,974,861
Scios Llc	NATRECOR	nesiritide	FOR SOLUTION;INTRAVENOUS	020920-001	Aug 10, 2001	5,674,710

International Patents for NATRECOR

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

Country	Patent Number	Title	Estimated Expiration
Ireland	68889	Recombinant techniques for production of novel natriuretic and vasodilator peptides
European Patent Office	0418308	TECHNIQUES RECOMBINANTES DE PRODUCTION DE NOUVEAUX PEPTIDES NATRIURETIQUES ET VASODILATATEURS. (RECOMBINANT TECHNIQUES FOR PRODUCTION OF NOVEL NATRIURETIC AND VASODILATOR PEPTIDES.)
Ireland	891792
Australia	3768189
Japan	2511160
Canada	1339210	TECHNIQUES RECOMBINANTES POUR LA PRODUCTION DE NOUVEAUX NATRIURETIQUES ET DE PEPTIDES VASODILATATEURS (RECOMBINANT TECHNIQUES FOR PRODUCTION OF NOVEL NATRIURETIC AND VASODILATOR PEPTIDES)

Market Dynamics and Financial Trajectory for NATRECOR (nesiritide)

Last updated: August 2, 2025

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Introduction

NATRECOR (nesiritide), a recombinant form of human B-type natriuretic peptide, was approved by the FDA in 2001 for the management of acutely decompensated congestive heart failure (CHF). Designed to induce vasodilation and reduce cardiac preload and afterload, NATRECOR aimed to address a significant unmet need within acute heart failure (AHF) treatment. Despite its initial promise, the drug's market performance has been marred by clinical controversies and shifting therapeutic landscapes, impacting its economic trajectory.

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Market Dynamics

1. Market Size and Unmet Medical Need

Acute decompensated heart failure remains a substantial global health challenge, with millions affected annually. The Global Heart Failure Market Size was valued at approximately USD 4.6 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of ~7% through 2027 [1]. NATRECOR, positioned within this market, targeted hospital settings requiring rapid symptom alleviation. However, competition from alternative therapies and rapid advances in heart failure management have influenced its market penetration.

2. Competitive Landscape

The therapeutic arsenal for acute decompensated CHF comprises inotropes, vasodilators, diuretics, and non-pharmacological interventions. Key competitors include nitroglycerin, nitroprusside, and newer agents such as serelaxin and levosimendan, which have gained favor due to efficacy and safety profiles [2].

Post-approval, conflicting clinical data and safety concerns about natriuretic peptides like NATRECOR dampened its adoption. The lack of clear mortality benefits, coupled with concerns over hypotension and renal impairment, led to conservative prescribing patterns.

3. Regulatory and Clinical Controversies

NATRECOR's approval was challenged by subsequent studies, notably the VMAC trial (2001), which demonstrated short-term symptomatic improvement but failed to establish definitive mortality benefit. The subsequent consensus guidelines expressed skepticism about widespread use, citing limited long-term outcome data.

In 2011, the FDA revised labeling to emphasize the limited impact on survival and hospitalization, further curbing its utilization [3]. These regulatory shifts significantly impacted sales volume and market demand.

4. Pricing and Reimbursement Policies

Initial pricing strategies positioned NATRECOR as a premium treatment. However, reimbursement challenges and comparisons with less expensive vasodilators led to margin compression. Hospitals prioritized therapies demonstrating clear benefits, favoring cost-effective options.

Payers' reluctance to reimburse for interventions with uncertain mortality benefits impacted revenue streams, especially amid increasing emphasis on value-based care.

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Financial Trajectory

1. Sales Performance

NATRECOR experienced a rapid decline in sales following its initial launch. Annual revenues peaked in the early 2000s but declined sharply after 2005. For instance, reported revenues fell from approximately USD 250 million in 2002 to under USD 50 million by 2010 [4].

By the 2010s, sales had dwindled considerably, driven by clinical and regulatory headwinds. In 2012, the drug's manufacturer announced discontinuation of production in many regions, reflecting diminished commercial viability.

2. Patent and Market Exclusivity

Unlike novel drugs with extended patent protections, NATRECOR's patent landscape was limited, with key exclusivities expiring by the late 2000s. This eroded its competitive moat, inviting generic or biosimilar entries ahead of expectations, further pressuring prices and revenues.

3. Impact of Regulatory Decisions

The FDA's revised labeling and guidance significantly curtailed prescribing. With mounting evidence questioning efficacy and safety, the financial returns from NATRECOR diminished, rendering continued commercialization unprofitable. Manufacturers shifted focus toward pipeline assets or other therapeutic areas.

4. Strategic Responses

Pharmaceutical firms engaged in restructuring, divestment, or selling off assets related to NATRECOR. Some attempted repositioning through clinical trials exploring novel indications, but minimal clinical or commercial success was reported.

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Future Outlook

The outlook for NATRECOR remains bleak. Ongoing advances in heart failure management, especially with novel biologics and device therapies, further diminish its relevance. The drug’s lifecycle exemplifies how clinical efficacy, safety, regulatory policy, and competitive dynamics influence financial trajectories of pharmaceutical assets.

The limited growth prospects suggest minimal opportunities for resurgence unless new clinical data or combinations demonstrate substantial benefits over existing therapies.

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Key Market and Financial Insights

• Market Penetration: Initially promising, NATRECOR's usage quickly plateaued due to efficacy concerns and competition.
• Revenue Decline: Peak revenues in early 2000s, followed by a steep decline by 2010, leading to market exit.
• Regulatory Impact: FDA label revisions and clinical controversies contributed substantially to declining sales.
• Competitive Pressure: Availability of cost-effective alternatives and emerging therapies overshadowed NATRECOR’s therapeutic niche.
• Strategic Shift: Manufacturers moved away from NATRECOR, aligning focus with more promising pipeline candidates.

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Key Takeaways

• Clinical Evidence Is Crucial: The lack of evidence for mortality benefit or superior safety profiles led to rapid market erosion for NATRECOR.
• Regulatory Policies Shape Market Trajectory: Label updates reflecting safety and efficacy concerns directly influence prescribing practices and financial outcomes.
• Competitive Landscape Defines Longevity: Drugs without clear differentiation or long-term benefits risk obsolescence in a dynamic market.
• Reimbursement and Pricing Tactics: Cost containment measures and payer preferences significantly influence revenues.
• Pipeline Innovation Is a Must: Continual investment in clinical trials and novel indications can potentially reverse unfavorable financial trends.

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FAQs

1. Why did NATRECOR fail to sustain long-term market success?
Despite initial approval, clinical trials failed to demonstrate mortality benefits, and safety concerns led to regulatory revisions and reduced prescriber confidence, resulting in declining sales.

2. Are there any current clinical trials or new indications for NATRECOR?
As of 2023, no significant ongoing trials are focused on NATRECOR, and its commercial use has been largely discontinued. Research efforts have shifted toward newer therapeutics.

3. How does NATRECOR’s market performance compare with other heart failure drugs?
NATRECOR's market performance is notably weaker due to early safety concerns and lack of long-term benefits, unlike some drugs that have demonstrated substantial survival advantages.

4. What lessons can pharmaceutical companies learn from NATRECOR’s trajectory?
Rigorous clinical validation, transparent safety profiling, and strategic positioning are essential. Regulatory flexibility in light of emerging data is critical to sustain market relevance.

5. Could biosimilars impact NATRECOR’s future market?
Given the low market share realized and discontinuation efforts, biosimilars are unlikely to affect NATRECOR’s already diminished footprint.

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References

[1] MarketWatch. "Global Heart Failure Market Size to Reach USD 4.6 Billion by 2027." 2020.
[2] Gheorghiade M, et al. "Management of acute decompensated heart failure." JAMA. 2004.
[3] FDA. "NATRECOR (nesiritide) Label Revision." 2011.
[4] EvaluatePharma. "Pharmaceutical Sales Data, 2010–2012."