CERETEC Drug Patent Profile

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

Ceretec is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in CERETEC is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.

Summary for CERETEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Drug Prices:	Drug price information for CERETEC
What excipients (inactive ingredients) are in CERETEC?	CERETEC excipients list
DailyMed Link:	CERETEC at DailyMed

See drug prices for CERETEC

Recent Clinical Trials for CERETEC

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

Sponsor	Phase
Norton Healthcare	Phase 2
University of Kentucky	Phase 2
Thomas Hatschek	Phase 2

See all CERETEC clinical trials

Pharmacology for CERETEC

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for CERETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988		RX	Yes	Yes

Expired US Patents for CERETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988

International Patents for CERETEC

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

Country	Patent Number	Title	Estimated Expiration
Germany	123504
South Africa	8403069
United Kingdom	8506249
Australia	564636
Denmark	205284
Canada	1252481	COMPLEXES DE TECHNETIUM-99 AVEC DES OXIMES DE PROPYLENE-AMINE (COMPLEXES OF TECHNETIUM-99M WITH PROPYLENE AMINE OXIMES)

Supplementary Protection Certificates for CERETEC

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

Market Dynamics and Financial Trajectory for CERETEC

Last updated: July 28, 2025

---

Introduction

CERETEC (oxyquinolinium pentavalent technetate) is a radiopharmaceutical primarily utilized in diagnostic imaging procedures, specifically for assessing regional cerebral blood flow in neurology and detecting infections or inflammation in oncology and infectious disease contexts. Given its specialized application, CERETEC’s market trajectory hinges on factors like technological advances, regulatory landscapes, clinical demand, and competitive positioning. Understanding the intricate market dynamics and financial outlook for CERETEC offers insights for stakeholders ranging from pharmaceutical firms to investors.

---

Market Overview

CERETEC operates within the niche segment of cerebral and tumor imaging radiopharmaceuticals. Globally, the nuclear medicine market estimates to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by increasing prevalence of neurological disorders, rising adoption of diagnostic imaging, and expanding healthcare infrastructure in emerging economies [1].

Despite its specialized use, CERETEC’s market is relatively stable due to its established role in diagnostic protocols. Nevertheless, evolving alternatives and regulatory shifts influence its market retention and expansion.

---

Market Drivers

1. Rising Incidence of Neurological Disorders

The burden of stroke, Alzheimer’s disease, and other neurodegenerative conditions contributes to heightened demand for diagnostic imaging agents like CERETEC. The World Health Organization projects that neurological disorders will become the leading cause of disability-adjusted life years (DALYs) globally by 2030. This trend correlates with increased utilization of cerebral perfusion imaging, bolstering demand for agents such as CERETEC.

2. Advances in Nuclear Medicine Technology

Technological improvements, including hybrid imaging systems (PET/CT and SPECT/CT), enhance imaging precision. CERETEC’s compatibility with single-photon emission computed tomography (SPECT) systems favors its continued use, especially where advanced PET imaging is unavailable, directly influencing its market presence.

3. Regulatory Approvals and Reimbursement Policies

Regulatory environments that streamline approvals for radiopharmaceuticals and favorable reimbursement policies underpin market stability. Governments and insurers increasingly recognize the value of early and accurate diagnosis, incentivizing the use of established agents like CERETEC.

Market Challenges

1. Emerging Therapeutic and Diagnostic Alternatives

Novel imaging agents leveraging PET technology, such as florbetapir or amyloid-specific radiotracers, pose competition for CERETEC, especially in neurodegenerative disease diagnostics. Moreover, advancements in non-radioactive diagnostic modalities reduce reliance on nuclear medicine.

2. Shorter Half-life of Technetium-99m

CERETEC’s reliance on technetium-99m (half-life ~6 hours) limits logistical distribution, restricting availability primarily to centralized facilities. Recent innovations in generator technology aim to mitigate these limitations but add complexity and cost.

3. Regulatory and Market Access Barriers

Stringent approval processes for radiopharmaceuticals, particularly in emerging markets, can delay market entry and commercialization, affecting revenue streams.

---

Financial Trajectory Analysis

Current Revenue Streams

CERETEC generates revenue through sales to hospitals and diagnostic centers. In mature markets like North America and Europe, sales are relatively saturated, generating stable revenue, but with limited growth potential absent new indications or formulations.

Growth Potential in Emerging Markets

Expanding healthcare infrastructure in Asia-Pacific, Latin America, and Africa opens avenues for increased CERETEC adoption. Government investments in nuclear medicine centers and rising awareness of diagnostic imaging further improve market prospects.

R&D and Pipeline Developments

Investments in next-generation technetium-labeled agents or combination diagnostics could redefine future revenue streams. Improving stability, reducing costs, or expanding indications through clinical trials could enhance commercial viability.

Pricing Dynamics

Pricing pressures from government healthcare policies and competition influence profit margins. Cost-effective production, especially leveraging generator technology, remains vital to maintaining healthy margins and competitive pricing.

---

Regulatory and Policy Impacts

Regulatory approvals directly impact CERETEC’s marketability. For example, the U.S. FDA’s approval status, EMA’s designations, and country-specific policies shape regional revenue opportunities. Additionally, increased focus on radiation safety standards can influence manufacturing protocols and market access strategies.

---

Competitive Landscape

CERETEC competes primarily with other SPECT radiotracers like HMPAO (hexamethylpropyleneamine oxime) and newer agents under development. The emergence of PET-based tracers with higher resolution and sensitivity could threaten its dominance unless CERETEC’s applications expand or innovation occurs.

---

Forecasting the Financial Trajectory

Based on current trends and market SWOT analyses, CERETEC’s financial outlook can be summarized as:

• Moderate Growth in Stable Markets: Established use ensures steady revenue with minimal volatility.
• Potential Uptick in Emerging Economies: Healthcare investments and favorable policies could result in a compound annual growth rate of 3-5% over five years.
• Innovation-Driven Upside: Successful pipeline development or label expansions could accelerate revenue growth beyond market averages.
• Competitive Risks: Technological shifts toward PET agents may reduce future revenue unless adaptations are made.

---

Strategic Implications for Stakeholders

Investors should monitor regulatory pathways, technological developments, and regional market expansion strategies. Pharmaceutical owners must consider enhancing manufacturing efficiencies, investing in R&D, and developing complementary imaging agents. Health systems benefit from integrating CERETEC into broader diagnostic protocols optimized for cost and accuracy.

---

Key Takeaways

• Stable yet evolving market: CERETEC occupies a niche with consistent demand driven by neurological disease diagnostics but faces competition from advanced imaging agents.
• Regional growth opportunities: Emerging markets offer considerable upside, provided regulatory barriers are managed and clinical awareness increases.
• Innovation as a growth catalyst: Pipeline developments and formulation improvements are essential to sustain competitiveness amid technological shifts.
• Pricing pressures: Cost management and generator technology optimization are critical for maintaining margins.
• Regulatory landscape influence: Approvals and reimbursement policies will significantly shape CERETEC’s financial trajectories.

---

FAQs

1. How does CERETEC compare to newer PET-based neuroimaging agents?
CERETEC remains a mainstay in SPECT imaging due to its established safety profile and cost-effectiveness. PET agents offer higher resolution but are often more expensive and less accessible, positioning CERETEC favorably in resource-limited settings.

2. What regulatory hurdles does CERETEC face in expanding markets?
Stringent safety standards, approval processes for radiopharmaceuticals, and requirements for manufacturing consistency may delay market entry. Harmonization efforts and regional regulatory fast-tracking can mitigate these challenges.

3. What is the outlook for CERETEC in emerging economies?
Growing healthcare infrastructure, increasing awareness of nuclear medicine, and government investments in diagnostic capabilities are expected to boost CERETEC adoption, leading to higher revenues.

4. Can technological innovations improve CERETEC’s logistical challenges?
Yes, developments in technetium generators and lyophilized kits can extend shelf life, streamline production, and facilitate distribution, especially in decentralized settings.

5. What strategic moves should pharmaceutical companies consider for CERETEC’s future?
Investing in pipeline development, expanding indications, optimizing production costs, and establishing collaborations can help sustain market relevance amid evolving diagnostic landscapes.

---

References

[1] MarketsandMarkets. (2023). Nuclear Medicine Market by Application, Type, and Region.