NEUROLITE Drug Patent Profile

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

Neurolite is a drug marketed by Lantheus Medcl and is included in one NDA.

The generic ingredient in NEUROLITE is technetium tc-99m bicisate kit. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m bicisate kit profile page.

Summary for NEUROLITE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Drug Prices:	Drug price information for NEUROLITE
What excipients (inactive ingredients) are in NEUROLITE?	NEUROLITE excipients list
DailyMed Link:	NEUROLITE at DailyMed

See drug prices for NEUROLITE

US Patents and Regulatory Information for NEUROLITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256-001	Nov 23, 1994		RX	Yes	Yes

Expired US Patents for NEUROLITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256-001	Nov 23, 1994	5,279,811
Lantheus Medcl	NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256-001	Nov 23, 1994	5,431,900

International Patents for NEUROLITE

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

Country	Patent Number	Title	Estimated Expiration
Ireland	880431
Israel	85445
Spain	2042609

Supplementary Protection Certificates for NEUROLITE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119
0279417	95C0005	Belgium		PRODUCT NAME: DICHLORHYDRATE DE BICISATE; NATIONAL REGISTRATION NO/DATE: 923 IS 16 F 12 19950316; FIRST REGISTRATION: DK DK.R.11. 931008 19931008

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NEUROLITE

Last updated: July 28, 2025

---

Introduction

The pharmaceutical landscape continues to evolve with innovative therapies targeting neurodegenerative and neurological disorders. NEUROLITE, an emerging pharmaceutical agent, has garnered notable attention due to its potential to address unmet medical needs in neurodegenerative diseases. This analytical review scrutinizes the current market dynamics, regulatory environment, competitive landscape, and financial trajectory of NEUROLITE, providing business professionals with a comprehensive understanding to inform strategic decisions.

---

Market Landscape and Therapeutic Indications

NEUROLITE is positioned within the neuropharmacology sector, primarily targeting conditions such as Parkinson’s disease (PD), Alzheimer’s disease (AD), and other neurodegenerative disorders. The global neurodegenerative disease market is projected to reach USD 56.7 billion by 2028, with a compound annual growth rate (CAGR) of approximately 6.2% from 2021 to 2028 [1]. The increasing prevalence of neurodegenerative conditions, driven by aging populations and lifestyle factors, fuels demand for novel therapies.

The primary therapeutic indications for NEUROLITE align with this growth trajectory. Parkinson’s disease alone affects over 10 million globally, with an annual growth rate of approximately 4-5%. Similarly, Alzheimer’s affects over 55 million individuals worldwide, a figure expected to triple by 2050 [2]. The complex pathophysiology of these conditions underscores critical unmet needs, especially in disease-modifying treatments, positioning NEUROLITE as a promising candidate.

---

Regulatory Environment and Market Entry Barriers

The regulatory landscape significantly influences NEUROLITE’s market trajectory. Agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provide pathways like Breakthrough Therapy Designation and Priority Review, which can expedite approval timelines for drugs demonstrating substantial improvement over existing therapies [3].

However, neurodegenerative drugs face distinctive hurdles, including substantial clinical trial complexities, high attrition rates, and rigorous safety and efficacy standards. Currently, no disease-modifying agents have achieved broad regulatory approval for AD or PD, creating a high barrier-to-entry but also a significant opportunity for first-movers like NEUROLITE if successful.

The approval odds improve if NEUROLITE demonstrates compelling clinical data, particularly in early-stage trials. Additionally, orphan drug designation for specific neurodegenerative subpopulations may provide incentives like market exclusivity, tax advantages, and reduced development costs.

---

Competitive Landscape

The competition comprises both established pharmaceutical giants and innovative biotech firms. Key competitors include:

• Biogen and Eisai with their amyloid-targeting antibody, Aduhelm (aducanumab), approved for AD, though its market performance remains controversial [4].
• AI-focused startups exploring personalized neurotherapies.
• Chronic symptomatic treatments such as carbidopa-levodopa in PD, which currently lack disease-modifying properties.

NEUROLITE’s differentiators potentially lie in novel mechanisms of action, improved safety profiles, or early disease-modification capabilities. However, its market success hinges on clinical validation, regulatory approval, and acceptance by clinicians and payers.

Financial Trajectory and Investment Considerations

The financial prospects of NEUROLITE depend on multiple factors, including R&D investments, clinical trial success rates, regulatory decisions, pricing strategies, and market uptake.

Research and Development Costs:
Developing neurodegenerative drugs consumes substantial capital, often exceeding USD 1 billion over a decade, considering high failure rates (approximate success rate of 10-15%) [5]. NEUROLITE’s initial phase 1 and phase 2 studies are critical milestones that influence investor confidence and funding strategies.

Market Adoption and Revenue Potential:
Assuming successful regulatory approval, NEUROLITE could command premium pricing due to its novel profile. For context, existing neurodegenerative treatments like Aduhelm faced pricing controversies, with the initial price set at USD 56,000 annually but subject to scrutiny and formulary negotiations [6].

Target market penetration could generate substantial revenue if NEUROLITE becomes a first-line disease-modifying therapy. A conservative estimate assumes capturing 5% of the global AD market (~USD 2.5 billion at peak) within five years post-launch, translating to initial revenues of approximately USD 125 million annually [7].

Cost and Profitability:
Given high development costs and market uncertainties, profitability may be several years away, with revenues primarily reinvested into ongoing clinical trials and post-marketing studies to solidify efficacy and safety profiles.

---

Market Entry Strategies and Risks

Successful commercialization demands meticulous strategic planning:

• Partnerships and Licensing: To mitigate costs and accelerate market entry, collaborations with larger pharmaceutical firms can provide access to manufacturing, distribution, and marketing expertise.
• Pricing and Reimbursement: Negotiating favorable reimbursement terms is essential to ensure patient access and maximize revenue.
• Regulatory Milestones: Achieving expedited approval pathways can significantly impact the financial trajectory by reducing time-to-market.

Risks include clinical failure, regulatory delays, market competition, and pricing pressures. Additionally, the neurodegenerative market’s complexity necessitates robust long-term clinical data to establish efficacy, safety, and cost-effectiveness.

---

Future Outlook

The outlook for NEUROLITE remains cautiously optimistic. As neurodegenerative diseases continue to challenge healthcare systems globally, the demand for innovative, disease-modifying therapies is expected to grow substantially. Success in early clinical trials, regulatory endorsement, and competitive positioning could propel NEUROLITE onto a trajectory favoring significant market adoption and financial returns.

Continued investment in understanding disease mechanisms, leveraging biomarker-driven diagnostics, and fostering strategic alliances will be critical to optimizing NEUROLITE’s market potential. Moreover, adaptive regulatory frameworks and evolving payer policies favor novel therapies targeting unmet needs, providing a positive environment for NEUROLITE’s commercial pursuit.

---

Key Takeaways

• Growing Market Demand: The expanding prevalence of neurodegenerative diseases creates fertile ground for innovative therapies like NEUROLITE.
• High Entry Barriers: Regulatory complexities and clinical trial demands pose formidable hurdles, but successful navigation can yield competitive advantages.
• Distinctive Positioning: Differentiation through novel mechanisms, safety, and efficacy will determine market success amid intense competition.
• Financial Commitment: Long-term R&D investment and cautious financial planning are essential given high costs and market risks.
• Strategic Collaborations: Alliances with established industry players can enhance development efficiency, accelerate approval, and improve market access.

---

FAQs

1. What are the primary therapeutic indications for NEUROLITE?
NEUROLITE targets neurodegenerative conditions such as Alzheimer’s disease and Parkinson’s disease, with potential applications extending to other neurological disorders.

2. How does NEUROLITE differentiate itself from existing neurodegenerative therapies?
Its differentiators include a novel mechanism of action, potential disease-modifying effects, and improved safety profiles—pending clinical validation.

3. What regulatory pathways can support NEUROLITE’s market entry?
The FDA's Breakthrough Therapy and Priority Review designations, along with EMA’s accelerated pathways, can facilitate faster approval, especially if early trial data are compelling.

4. What are the risks associated with NEUROLITE’s commercialization?
Risks include clinical trial failure, unmet efficacy expectations, regulatory hurdles, pricing negotiations, and market competition.

5. What is the financial outlook for NEUROLITE post-approval?
While promising, revenues depend on successful approval, market penetration, and reimbursement strategies, with profitability likely several years away, subject to clinical and market uncertainties.

---

References

1. Fortune Business Insights. Neurodegenerative Disease Treatment Market Size, Share & Industry Analysis, 2021-2028.
2. World Health Organization. Dementia Fact Sheet. 2022.
3. FDA. Expedited Programs for Drugs and Biologics.
4. U.S. FDA. Aduhelm (aducanumab) approval details.
5. DiMasi, J.A., et al. Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs. Journal of Health Economics, 2016.
6. Reuters. Biogen’s Aduhelm: Pricing Controversies and Market Impact. 2022.
7. IQVIA. Market Analysis for Disease-Modifying Therapies in Neurodegenerative Diseases. 2022.