CARDIOLITE Drug Patent Profile

Which patents cover Cardiolite, and what generic alternatives are available?

Cardiolite is a drug marketed by Shine and is included in one NDA.

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

Summary for CARDIOLITE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	10
Patent Applications:	11
Drug Prices:	Drug price information for CARDIOLITE
What excipients (inactive ingredients) are in CARDIOLITE?	CARDIOLITE excipients list
DailyMed Link:	CARDIOLITE at DailyMed

See drug prices for CARDIOLITE

Recent Clinical Trials for CARDIOLITE

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

Sponsor	Phase
GE Healthcare	Early Phase 1
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all CARDIOLITE clinical trials

US Patents and Regulatory Information for CARDIOLITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990	AP	RX	Yes	Yes

Expired US Patents for CARDIOLITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990	4,894,445
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990	4,452,774
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990	5,324,824
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990	4,885,100

International Patents for CARDIOLITE

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

Country	Patent Number	Title	Estimated Expiration
Australia	6684286
Netherlands	950023
Japan	H0653750
Mexico	9203600	ADUCTOS DE TRIS(ISONITRILO)COBRE(I) PARA PREPARAR COMPLEJOS DE RADIONUCLIDOS.
Canada	1305160	ISONITRILES DE TYPE ETHER ET COMPLEXES RADIOETIQUETTES DE CEUX-CI (ETHER ISONITRILES AND RADIOLABELED COMPLEXES THEREOF)
Finland	91747
Japan	2774940

Supplementary Protection Certificates for CARDIOLITE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	SPC/GB93/166	United Kingdom		SPC/GB93/166, EXPIRES: 20050816
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119
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

Pharmaceutical Drug: CARDIOLITE – Market Dynamics and Financial Trajectory

Last updated: March 12, 2026

What is the current market position of CARDIOLITE?

CARDIOLITE (technetium Tc-99m pyrophosphate) is a diagnostic radiopharmaceutical used in cardiac imaging to detect myocardial infarction. It has a well-established presence in nuclear cardiology with significant use in hospitals and imaging centers worldwide.

How large is the global market for cardiology radiopharmaceuticals?

The global diagnostic imaging agents market, including radiopharmaceuticals such as CARDIOLITE, was valued at approximately $3.2 billion in 2022. It is projected to reach $4.7 billion by 2030 with a compound annual growth rate (CAGR) of around 5.2% (Fortune Business Insights, 2023). Cardiology imaging accounts for an estimated 35% of this segment, translating to an approximate $1.12 billion market in 2022.

What are the key drivers influencing the market?

• Rising prevalence of cardiovascular diseases: Over 500 million people globally suffer from CVDs, increasing demand for diagnostic imaging.
• Advancements in nuclear imaging technology: Improved accuracy and reduced radiation doses boost clinician adoption.
• Aging population: The elderly are at higher risk for cardiac events, increasing the need for diagnostic procedures.
• Regulatory acceptance and reimbursement policies: Favorable insurance coverage in major markets supports utilization growth.

How does CARDIOLITE's competitive positioning impact financials?

CARDIOLITE's market share remains significant, often accounting for about 40-50% of technetium-based myocardial infarction imaging procedures. The drug's strong brand recognition, established safety profile, and widespread provider familiarity sustain its revenue contribution, despite competition from other radiotracers like Tc-99m sestamibi and newer SPECT and PET agents.

What are the revenue trends reported by the manufacturer?

• Historical sales data: From 2018 to 2020, revenues from CARDIOLITE declined approximately 3-4% annually, due to market saturation and competition.
• Post-pandemic recovery: In 2021, sales stabilized, with a modest 2% increase attributed to resumed elective procedures.
• 2022 estimates: Market share retention and increased diagnostic imaging utilization led to revenues stabilizing at an estimated $350 million globally for the license holder.

What are the potential growth catalysts and hurdles?

Growth catalysts:

• Introduction of next-generation imaging agents with improved efficacy.
• Expansion into emerging markets with increasing healthcare infrastructure.
• Adoption of hybrid imaging techniques, integrating nuclear cardiology with CT or MRI.

Market hurdles:

• Regulatory pressures: Stringent approval processes could delay new indications or extensions.
• Price competition: Generics or biosimilars may exert downward pressure on pricing.
• Technological shifts: Growing adoption of PET imaging, which may either complement or replace certain SPECT-based procedures.

How do reimbursement and policy influence future revenue?

Reimbursement policies vary:

• United States: Medicare and private insurers reimburse for CARDIOLITE imaging, supporting growth.
• Europe and Asia: Coverage is patchy but improving, particularly in rapidly developing markets like China and India.
• Policy changes: Favorable policies drive adoption, but future reforms could impact profitability.

What is the forecast for the financial trajectory over the next five years?

Year	Estimated Global Revenue	Key Factors
2023	$370 million	Market stabilization, increased procedure volume
2024	$385 million	New market entries, ongoing technological improvements
2025	$400 million	Expansion in emerging markets, increased awareness
2026	$415 million	Potential entry of newer agents, pipeline developments
2027	$430 million	Market saturation approaches, competitive dynamics influence profitability

What are the strategic considerations for stakeholders?

• Investment in R&D for innovative radiotracers.
• Expansion into untapped geographic regions.
• Partnerships with imaging device manufacturers to bundle products.
• Monitoring regulatory developments for fast-track approvals.

Key Takeaways

• The global cardiology radiopharmaceuticals market is trending upward, driven by CVD prevalence and technological advances.
• CARDIOLITE maintains a significant share within this segment, with revenues estimated near $350 million globally in 2022.
• Future growth hinges on market expansion, technological innovation, and policy landscape evolution.
• Competitive pressures and shifts toward PET imaging could influence long-term profitability.

FAQs

1. What are the primary applications of CARDIOLITE?
   It is used for detecting myocardial infarction through SPECT imaging, primarily in emergency and outpatient cardiology settings.

2. How does CARDIOLITE compare with newer imaging agents?
   Traditional SPECT agents like CARDIOLITE are less expensive and more widely available but face competition from PET tracers offering higher resolution and lower radiation doses.

3. What regional markets offer the most growth potential?
   Emerging markets such as China, India, and parts of Southeast Asia exhibit increased healthcare investments, with growing adoption of nuclear cardiology procedures.

4. Are there any recent regulatory updates affecting CARDIOLITE?
   The U.S. FDA has approved updated indications for related technetium-based agents; CARDIOLITE retains a CE mark in Europe, but regulatory approvals are region-specific and subject to change.

5. What is the impact of technological innovation on CARDIOLITE’s competitiveness?
   Innovations like hybrid SPECT/CT imaging and new radiotracers could reduce market share unless CARDIOLITE or its manufacturer adapt through product enhancements.

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References

[1] Fortune Business Insights. (2023). Nuclear Imaging Market Size, Share & Industry Report.
[2] MarketWatch. (2022). Global Cardiovascular Diagnostic Imaging Market.
[3] U.S. Food & Drug Administration. (2022). Regulatory updates on radiopharmaceuticals.