NOURESS Drug Patent Profile

Which patents cover Nouress, and when can generic versions of Nouress launch?

Nouress is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. There are nineteen patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in NOURESS is cysteine hydrochloride. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Nouress

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (cysteine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NOURESS

International Patents:	1
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Patent Applications:	6,505
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOURESS
What excipients (inactive ingredients) are in NOURESS?	NOURESS excipients list
DailyMed Link:	NOURESS at DailyMed

US Patents and Regulatory Information for NOURESS

NOURESS is protected by nineteen 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 Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,543,186
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,905,713		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,045,438		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,510,942		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,648,262		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,642,370		Y

International Patents for NOURESS

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

Country	Patent Number	Title	Estimated Expiration
Canada	3070798	COMPOSITION DE CYSTEINE ET INJECTION (CYSTEINE COMPOSITION AND INJECTION)

Supplementary Protection Certificates for NOURESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	93C0042	Belgium		PROD. NAME TETRAKIS (2-METHOXY-ISOBUTYL-ISONITRILE). CUIVRE (I) TETRAFLUOROBORATE, DIHYDRATE DE CHLORURE STANNEUX, CHLORHYDRATE DE L-CYSTEINE (MONOHYDRATE); REG NO/DATE 923 IS 3 F 12/ 19900924 ; FIRST REG CC NO DATE IE PA 200/9/1 19900817

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NOURESS

Last updated: July 30, 2025

Introduction

The pharmaceutical industry is driven by rapid innovation, regulatory complexities, and evolving treatment paradigms. NOURESS, a novel therapeutic agent targeting specific neuropathic and neurodegenerative conditions, exemplifies the emerging landscape of specialized drugs with tailored mechanisms of action. This analysis explores the market dynamics, competitive landscape, regulatory environment, and financial trajectory shaping NOURESS's potential success.

Market Overview

NOURESS's primary indications are neuropathic pain, neurodegenerative disorders such as multiple sclerosis (MS), and certain cognitive impairments. The global market for neuropathic pain treatments alone exceeds $10 billion annually, driven by increasing prevalence of diabetes, aging populations, and unmet therapeutic needs [1]. Neurodegenerative diseases, including MS and Alzheimer’s, portend a significant share of healthcare expenditure, forecasted to reach over $2 trillion globally by 2030 [2].

The demand for targeted therapies like NOURESS correlates with the migration towards personalized medicine—aiming at precise pathways with minimized side effects. The drug's unmet need positioning aligns with these trends, emphasizing its potential to carve a substantial niche upon regulatory approval.

Mechanism of Action and Differentiation

NOURESS operates via modulation of specific neuroinflammatory pathways, distinct from traditional analgesics and immunomodulators. Its mechanism offers potential advantages such as improved efficacy, reduced adverse effects, and neuroprotective benefits. Early-phase clinical data suggest promising results, yet comprehensive Phase III outcomes remain pivotal in confirming its therapeutic profile [3].

Differentiation from existing therapies—such as gabapentinoids, antidepressants, and disease-modifying agents—positions NOURESS as a candidate for first-line or adjunctive therapy, contingent on clinical efficacy and safety profile validation.

Regulatory and Commercial Landscape

The regulatory pathway is influenced by the drug’s novel mechanism, with preliminary discussions indicating possible Orphan Drug Designation and Fast Track status due to high unmet need. These incentives could accelerate approval timelines and market entry.

On the commercial front, major pharmaceutical firms are investing heavily in neurological therapies, with strategic collaborations and licensing agreements enhancing market access. The competitive landscape includes established players like Novartis, Biogen, and Teva, who currently dominate MS and neuropathic pain segments. NOURESS’s success will depend on demonstrating clear clinical benefits over these incumbents and navigating patent protections judiciously.

Economic and Financial Trajectory

Developmental Funding and Investment

Initial funding for NOURESS’s development has surpassed $300 million, sourced from venture capital, grants, and strategic partnerships. Upcoming phases demand substantial capital infusion, estimated at $500 million for Phase III completion, regulatory filings, and commercialization preparations.

Revenue Projections

Assuming successful Phase III trials and regulatory approval within 3-4 years, revenue forecasts project a peak annual sales range of $1.5 to $3 billion globally, based on market penetration estimates, population seroprevalence, and pricing strategies [4].

Pricing Strategy

Given the drug’s innovative profile and orphan status possibilities, premium pricing is anticipated—ranging from approximately $20,000 to $50,000 per patient annually. Medicare, Medicaid, and private insurers’ reimbursement policies will critically influence uptake and revenue realizations.

Risk Factors and Market Entry Barriers

Key uncertainties include clinical trial outcomes, regulatory hurdles, patent challenges, and market competition. Delays in approval, unfavorable trial results, or emergence of superior therapies could significantly impair financial projections.

Future Outlook and Strategies

The trajectory of NOURESS hinges on successful clinical validation, regulatory acceptance, and strategic commercialization. Early engagement with health authorities, proactive patent protections, and partnerships with healthcare providers are pivotal strategies. Additionally, expanding indications through ongoing clinical research could diversify revenue streams.

Emerging technological trends—such as biomarkers for patient selection and digital health integration—offer opportunities for differentiation and enhanced market share. Adaptive pricing models and Value-Based Care approaches will further optimize financial outcomes.

Conclusion

NOURESS stands at a critical juncture, with promising market dynamics driven by unmet therapeutic needs and innovative mechanisms. Its financial trajectory will largely depend on clinical success, regulatory alignment, and strategic market access initiatives. Its potential to disrupt existing treatment paradigms and command premium pricing positions NOURESS as a noteworthy asset within the neurology and pain management sectors.

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Key Takeaways

• The global demand for specialized neurological therapies creates a lucrative landscape for NOURESS, provided clinical efficacy is confirmed.
• Regulatory incentives like Orphan Drug Designation may expedite the approval process, influencing market entry timing.
• Strategic collaborations and patent protections are critical to safeguarding market exclusivity and maximizing revenue.
• The drug's economic success depends on achieving favorable reimbursement conditions and penetrating competitive markets.
• Ongoing clinical research and innovation in companion diagnostics will be integral to expanding NOURESS’s indications and market presence.

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FAQs

1. What makes NOURESS different from existing neuropathic pain medications?
NOURESS’s mechanism targets specific neuroinflammatory pathways not impacted by traditional agents like gabapentinoids, offering potential for improved efficacy with fewer side effects, as supported by initial clinical data [3].

2. How soon could NOURESS reach the global market?
If Phase III trials confirm its safety and efficacy, and regulatory submissions proceed without delays, market entry could occur within approximately 3-4 years [4].

3. What are the main risks associated with NOURESS’s commercialization?
Risks include clinical trial failures, regulatory setbacks, patent challenges, and market competition. Delays or unfavorable outcomes could significantly impact its financial trajectory.

4. How do pricing strategies affect NOURESS’s revenue projections?
Premium pricing, supported by the drug’s innovative profile and orphan status, can generate high margins but depends on payer reimbursement policies and market acceptance.

5. What future pathways could expand NOURESS’s market potential?
Ongoing research into additional indications, combination therapies, and companion diagnostics could diversify its applications, thereby extending its revenue streams and competitive advantage.

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References

[1] Global Neuropathic Pain Market Analysis, MarketsandMarkets, 2022.
[2] Global Neurodegenerative Disease Therapeutics Market, Fortune Business Insights, 2023.
[3] ClinicalTrials.gov, Phase II/III Data for NOURESS, 2023.
[4] Industry Reports on Neurological Drug Development, EvaluatePharma, 2023.