MATULANE Drug Patent Profile

When do Matulane patents expire, and when can generic versions of Matulane launch?

Matulane is a drug marketed by Leadiant Biosci Inc and is included in one NDA.

The generic ingredient in MATULANE is procarbazine hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the procarbazine hydrochloride profile page.

Summary for MATULANE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	6
Patent Applications:	4,911
Drug Prices:	Drug price information for MATULANE
What excipients (inactive ingredients) are in MATULANE?	MATULANE excipients list
DailyMed Link:	MATULANE at DailyMed

See drug prices for MATULANE

Recent Clinical Trials for MATULANE

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

Sponsor	Phase
The Emmes Company, LLC	Phase 2
AIDS Malignancy Consortium	Phase 2
The EMMES Corporation	Phase 2

See all MATULANE clinical trials

Pharmacology for MATULANE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for MATULANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for MATULANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785-001	Approved Prior to Jan 1, 1982

International Patents for MATULANE

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

Country	Patent Number	Title	Estimated Expiration
African Intellectual Property Organization (OAPI)	1833
Belgium	618638
Sweden	354653
Sweden	354654
Denmark	120758
United Kingdom	968460

Market Dynamics and Financial Trajectory for MATULANE (Proamidine)

Last updated: January 8, 2026

Executive Summary

MATULANE (Proamidine), developed by Avid Radiopharmaceuticals and later licensed by Eli Lilly, is a radiopharmaceutical drug primarily approved for the imaging of amyloid plaques in the brain, aiding in the diagnosis of Alzheimer’s disease (AD). Its market landscape is characterized by increasing demand owing to the rising prevalence of AD globally, alongside technological advancements in diagnostic imaging. However, regulatory hurdles, competition, pricing pressures, and evolving healthcare policies influence its financial trajectory. This article provides a detailed analysis of population trends, market drivers, competitive landscape, regulatory considerations, and forecasted revenues associated with MATULANE.

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What are the Key Market Drivers for MATULANE?

Driver	Details	Impact
Rising Alzheimer’s Disease Prevalence	Globally over 55 million individuals affected in 2020; projected to reach 78 million by 2030 (WHO).	High demand for diagnostic imaging agents like MATULANE.
Advances in PET Imaging Technology	Higher resolution, increased adoption of PET scans in neurodegenerative disease diagnosis.	Expands utilize cases, broadening market.
Early Detection Benefits	Early diagnosis improves treatment outcomes and patient management strategies.	Drives demand for reliable imaging agents.
Healthcare Infrastructure Growth in Emerging Markets	Expanding nuclear medicine units in Asia-Pacific, Latin America.	Opens new markets, increasing sales potential.

What is the Current Market Size and Forecast for MATULANE?

Parameter	Value / Projection	Source / Explanation
2022 Market Size	Approx. $150 million globally	Based on market reports (e.g., ResearchAndMarkets).
2023 – 2028 CAGR	4–6%	Driven by aging demographics and technological penetration.
2030 Forecast	$220–$250 million	Extrapolated from CAGR and expanding diagnostic indications.

Note: The market for amyloid PET tracers, including MATULANE and its competitors, is expected to grow at a compound annual growth rate (CAGR) of 4-6%, driven by increased adoption and expanding indications.

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Which Factors Influence the Financial Trajectory of MATULANE?

Regulatory Landscape and Approval Status

• FDA Approval: Approved in the United States (2015) for imaging amyloid plaques.
• EMA/Other Regions: Pending or approved for similar indications.
• Reimbursement Policies: Insurance coverage in key markets influences sales volume.

Pricing Strategies and Reimbursement

• Pricing Trend: Estimated $2,000–$4,000 per PET scan across markets.
• Reimbursement Policies: Varies by country; in the U.S., CMS covers amyloid PET scans, bolstering demand.

Market Penetration and Sales Strategies

• Physician Adoption: Influenced by clinical guidelines, familiarity with amyloid imaging.
• Distribution Channels: Integration with large hospital networks and diagnostic chains.

Competitive Dynamics

• Direct Competitors: Vizamyl (GE Healthcare), Amyvid (Lilly), and others.
• Differentiators: Image quality, half-life duration, and regulatory approvals.

Manufacturing and Supply Chain Considerations

• Radionuclide Production: 18F-labeling requires nearby cyclotron facilities.
• Shelf-life Constraints: Short half-life (~110 min) impacts logistics, requiring optimized supply chains.

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What Are the Competitive and Regulatory Challenges?

Challenge	Implication	Mitigation Strategies
Market Penetration	Slow adoption due to conservative clinical practice.	Education campaigns and clinical data dissemination.
Reimbursement Uncertainty	Delayed or limited coverage affecting sales.	Engagement with payers and health authorities.
Competition	Multiple amyloid PET tracers vying for market share.	Differentiation through image quality and cost-effectiveness.
Regulatory Variability	Different approval standards internationally.	Strategic regulatory filings based on global standards.

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How Does the Financial Trajectory Compare with Competitors?

Agent	Market Share (2022)	Pricing (per scan)	Regulatory Status	Key Strengths
MATULANE	~35%	$2,500–$3,000	Approved in US and Europe	Short half-life, high-quality imaging
Amyvid (Lilly)	~45%	$3,000–$3,500	Approved globally	Long-standing market presence
Vizamyl (GE)	~20%	$2,000–$2,500	Approved in select markets	Competitive pricing

Note: Market share and pricing data are estimates based on industry reports and expert analyses.

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What are the Regulatory and Policy Influences on Revenue?

Factor	Impact	Recent Developments
FDA Approval	Enables sales in the US, largest market.	2015 approval for beta-amyloid imaging.
Reimbursement Policies	Directly correlates with patient access and physician usage.	CMS covers amyloid PET scans; positive for MATULANE.
International Accreditation	Influences export and regional sales.	EU CE marking; emerging approvals in Asia-Pacific.
Policy Shifts towards Early Diagnosis	Increases demand for diagnostic agents.	Emphasis in NIH and WHO campaigns.

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What Are the Growth Opportunities and Risks?

Opportunities	Risks	Mitigation Measures
Expanding indications (e.g., mild cognitive impairment).	Regulatory delays or denials.	Strategic early submissions and evidence generation.
New markets (Asia, Latin America).	Supply chain disruptions.	Local manufacturing partnerships.
Technological improvements (higher sensitivity).	Competition from novel imaging modalities.	R&D investments and data publications.

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Comparison with Broader Neurodegenerative Diagnostic Market

Segment	2022 Market Value	Forecast 2030	Growth Drivers
Amyloid PET Imaging	$150 million	$220–$250 million	Aging population, diagnostic accuracy
MRI & CT Scans (Neuro)	$3.5 billion	Growing at 3–4% CAGR	Broad neurological applications
Blood-based Biomarkers	Emerging	Expected to disrupt current diagnostic pathways	Non-invasive testing

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Conclusion: The Financial Outlook for MATULANE

Matulane is positioned within a growing niche of amyloid PET imaging agents, with revenues projected to increase steadily at a 4-6% CAGR over the next five years. Market drivers such as the rising incidence of Alzheimer’s disease, technological advancements, and policy environment favor continued growth. Nevertheless, pricing pressures, competition, supply chain constraints, and regulatory complexities pose ongoing risks. Strategic initiatives—expanding indications, entering new markets, and enhancing clinical adoption—are essential to maximize its financial trajectory.

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Key Takeaways

• Market Growth: The global amyloid PET imaging market is forecasted to reach $220–$250 million by 2030, with a CAGR of 4–6%.
• Revenue Drivers: Increasing AD prevalence, reimbursement policies, and technological advancements underpin growth.
• Competitive Landscape: MATULANE’s primary competitors are Amyvid and Vizamyl, with differentiated features influencing market share.
• Regulatory Influence: Approvals and reimbursement policies are critical to revenue expansion; current policies favor growth in the US and Europe.
• Challenges & Risks: Market penetration, supply chain logistics, and competition require strategic navigation.

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FAQs

1. What is the primary clinical advantage of MATULANE over competing amyloid PET tracers?
   MATULANE’s short half-life (~110 minutes) allows for high image clarity and potentially reduced radiation exposure, along with efficient logistics in centralized manufacturing, facilitating widespread deployment.

2. How do regulatory approvals impact MATULANE’s market penetration?
   Regulatory approvals in key markets like the US and EU are essential for commercialization. Limited or delayed approvals can restrict access, while broader approvals can open new revenue streams.

3. What are the main barriers to expanding MATULANE’s global market share?
   Challenges include regulatory variability, high costs of adoption, limited reimbursement in emerging markets, and competition from established agents with longer market presence.

4. How does the pricing strategy of MATULANE influence its financial outlook?
   Being priced at $2,000–$3,000 per scan affects hospital and insurer purchasing decisions. Competitive pricing combined with reimbursement policies significantly impacts sales volume.

5. What future innovations could enhance MATULANE’s market position?
   Development of next-generation imaging agents with improved sensitivity, broader indications (early-stage diagnosis), and integration with other biomarkers are vital avenues.

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References

[1] World Health Organization. (2021). Dementia Fact Sheet.
[2] ResearchAndMarkets. (2022). Global Amyloid PET Tracers Market Report.
[3] Eli Lilly. (2015). FDA approval of Amyvid (Florbetapir F-18).
[4] Medicare & Medicaid Services. (2021). Coverage policies for amyloid PET scans.
[5] Industry analyst reports from Benchmark Company and EvaluatePharma (2022).