TECHNETIUM TC-99M MEBROFENIN KIT - Generic Drug Details

What are the generic sources for technetium tc-99m mebrofenin kit and what is the scope of freedom to operate?

Technetium tc-99m mebrofenin kit is the generic ingredient in two branded drugs marketed by Bracco and Sun Pharm Inds Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for TECHNETIUM TC-99M MEBROFENIN KIT

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
DailyMed Link:	TECHNETIUM TC-99M MEBROFENIN KIT at DailyMed

Recent Clinical Trials for TECHNETIUM TC-99M MEBROFENIN KIT

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
UNC Lineberger Comprehensive Cancer Center	Phase 1

See all TECHNETIUM TC-99M MEBROFENIN KIT clinical trials

US Patents and Regulatory Information for TECHNETIUM TC-99M MEBROFENIN KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	AP	RX	Yes	Yes
Sun Pharm Inds Inc	TECHNETIUM TC-99M MEBROFENIN	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	078242-001	Jan 29, 2008	AP	RX	No	No

Expired US Patents for TECHNETIUM TC-99M MEBROFENIN KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	4,418,208

Technetium Tc-99m Mebrofenin Kit Market Dynamics and Financial Trajectory

Last updated: September 9, 2026

Technetium Tc-99m mebrofenin is a mature diagnostic radiopharmaceutical used primarily for hepatobiliary imaging, including cholescintigraphy and evaluation of suspected acute cholecystitis. Its commercial market is small relative to therapeutic drugs and is driven by nuclear-medicine procedure volumes, hospital purchasing contracts, radiopharmacy distribution, and the availability of technetium-99m generators. The product has limited patent-driven exclusivity risk, but its supply chain has operational barriers that can protect incumbent market share.

Public companies do not generally disclose revenue for technetium Tc-99m mebrofenin separately. Financial performance is therefore best assessed through procedure demand, radiopharmaceutical distribution, reimbursement, manufacturing capacity, and competition from alternative hepatobiliary imaging methods.

What is technetium Tc-99m mebrofenin used for?

Technetium Tc-99m mebrofenin is a kit used to prepare a technetium-99m-labeled radiopharmaceutical for diagnostic imaging of the liver, gallbladder, biliary tract, and small intestine.

The principal clinical application is hepatobiliary iminodiacetic acid, or HIDA, imaging. The scan assesses:

• Acute cholecystitis and cystic-duct obstruction
• Gallbladder filling and ejection fraction
• Biliary obstruction
• Bile leaks
• Postoperative biliary complications
• Selected hepatobiliary disorders in pediatric patients

The commercial product is not supplied as a ready-to-inject radioactive medicine. It is a nonradioactive kit containing mebrofenin, which is reconstituted and labeled with sodium pertechnetate Tc-99m obtained from a technetium generator or an approved radiopharmacy supply.

The U.S. reference product is Choletec, marketed by Bracco Diagnostics. The FDA label identifies the product as a kit for the preparation of technetium Tc-99m mebrofenin injection. [1]

How does the technetium Tc-99m mebrofenin market work?

The market is a procedure-linked, hospital-based supply chain rather than a conventional prescription-drug market.

Market component	Economic role
Mebrofenin kit manufacturer	Produces and supplies the nonradioactive reagent kit
Radiopharmacy	Adds Tc-99m, performs quality control, and dispenses patient doses
Hospital or imaging center	Purchases doses or kits and performs imaging
Technetium generator supplier	Provides the radioisotope required for labeling
Payer	Reimburses the imaging procedure and associated radiopharmaceutical cost
Nuclear-medicine physician	Orders and interprets the study

Revenue depends less on the unit price of the kit than on the number of HIDA procedures performed and the hospital's procurement model. A radiopharmacy may purchase kits in volume and dispense patient-specific doses. Hospitals with in-house nuclear pharmacies may purchase kits directly.

The short physical half-life of Tc-99m, approximately six hours, makes local or regional distribution essential. This favors suppliers with reliable radiopharmacy networks, validated preparation procedures, and dependable generator access. The mebrofenin kit itself has a longer shelf life than the labeled drug, but the final product remains constrained by radioisotope availability and same-day operational requirements.

What is the FDA regulatory status of technetium Tc-99m mebrofenin?

Technetium Tc-99m mebrofenin is an FDA-approved diagnostic radiopharmaceutical kit. The reference product is Choletec, associated with Bracco Diagnostics.

The product is regulated as a prescription diagnostic drug. Its use requires preparation by qualified personnel and administration in a nuclear-medicine setting. The FDA-approved labeling covers preparation, radiochemical quality requirements, dosing, handling, radiation safety, and clinical use. [1]

FDA status and product characteristics

Item	Status
Active pharmaceutical component	Mebrofenin labeled with Tc-99m
Product type	Diagnostic radiopharmaceutical kit
Primary indication	Hepatobiliary imaging
Administration	Intravenous after radiolabeling
Primary users	Nuclear-medicine departments and radiopharmacies
Prescription status	Prescription use
Reference brand	Choletec
Main regulatory pathway	NDA for the reference product; abbreviated or hybrid pathways may apply to later products

The kit is not a biologic, so biosimilar regulation does not apply. Competitive products, if approved, would be generic or otherwise follow an abbreviated drug-approval pathway rather than the biosimilar pathway.

What patents protect technetium Tc-99m mebrofenin?

The core composition and use patents associated with mebrofenin and the Choletec product are mature and are not the primary commercial barrier today.

The commercial protection profile is more likely to depend on:

• FDA approval and regulatory know-how
• Manufacturing validation
• Radiochemical quality-control procedures
• Kit stability
• Sterile manufacturing capacity
• Supply agreements with radiopharmacies
• Tc-99m availability
• Hospital purchasing contracts
• Product-specific labeling and preparation instructions

Publicly visible commercial risk is therefore different from the risk associated with a newly launched therapeutic drug. A competitor would generally face limited remaining patent exposure for the underlying small-molecule imaging agent, but it would still need to establish an approved, reliable, sterile product and compete for radiopharmacy adoption.

How strong is the patent estate for Choletec?

The patent estate is commercially weak as a source of long-term exclusivity because the product has been marketed for decades. Any original composition, formulation, or use patents would be expected to have expired or to be irrelevant to current market protection.

The stronger barriers are operational:

1. A validated sterile kit manufacturing process.
2. Consistent radiochemical purity after Tc-99m labeling.
3. Stability data supporting commercial distribution.
4. Reliable supply of vial components and excipients.
5. Regulatory compliance for radioactive-drug preparation.
6. Established hospital and radiopharmacy contracts.

These barriers can reduce competitive entry even when patent protection is limited.

When does technetium Tc-99m mebrofenin lose exclusivity?

The product's core regulatory and patent exclusivity expired long ago. There is no commercially meaningful modern exclusivity period comparable to the five-year new chemical entity period or seven-year orphan-drug period.

The relevant exclusivity structure is:

Exclusivity type	Relevance
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not the primary basis of market protection
Pediatric exclusivity	Not commercially material
Patent exclusivity	Mature or expired for the core product
Regulatory exclusivity for a new formulation	Could apply only to a separately approved later product
Trade-secret protection	Potentially relevant to manufacturing and quality systems

No current patent cliff appears likely to create a sudden collapse in market value. The product is already in the post-exclusivity phase. Market share changes would more likely result from supply disruptions, contracting, manufacturing changes, or the entry of an approved competitor.

What is the Orange Book status of technetium Tc-99m mebrofenin?

The FDA Orange Book is the principal source for listed patents and exclusivity associated with approved drugs. For a mature kit product such as Choletec, the practical question is whether any unexpired, listed patents block an abbreviated applicant.

The product's commercial profile does not indicate a significant active Orange Book patent barrier. A definitive legal determination would depend on the current Orange Book entry, listed patents, and any later-approved product-specific claims. [2]

For business planning, the key point is that Orange Book status is unlikely to be the main determinant of entry. Manufacturing, FDA review, radiopharmacy adoption, and supply-chain execution are more important.

Are there Paragraph IV challenges to Choletec?

No major, widely reported Paragraph IV litigation has reshaped the U.S. market for technetium Tc-99m mebrofenin.

A Paragraph IV challenge would require an abbreviated applicant to assert that a listed patent is invalid, unenforceable, or not infringed. Because the product's core exclusivity is mature, the litigation incentive is lower than for a high-revenue chronic therapy.

Potential entrants would more likely pursue a standard abbreviated approval strategy and compete after regulatory approval without a litigation-centered launch plan. The expected value of a challenge is constrained by the relatively small market and by the cost of establishing radiopharmaceutical manufacturing and distribution.

What drives demand for technetium Tc-99m mebrofenin?

Demand is linked to diagnostic practice, emergency-department utilization, surgical throughput, and nuclear-medicine capacity.

Acute-care demand

HIDA imaging remains clinically relevant when ultrasound is nondiagnostic or when physicians need functional information about gallbladder filling and biliary drainage. The test is particularly important in suspected acute cholecystitis when clinical findings and ultrasound results do not resolve the diagnosis.

Procedure substitution

The main competitive alternatives are:

• Abdominal ultrasound
• Computed tomography
• Magnetic resonance cholangiopancreatography
• Endoscopic retrograde cholangiopancreatography for selected therapeutic cases
• Clinical observation and repeat imaging

Ultrasound is usually the first-line test for suspected gallbladder disease because it is widely available, less expensive, and does not require a radiopharmaceutical. HIDA imaging retains value when functional assessment is needed or when ultrasound findings are equivocal.

Hospital capacity

The product depends on access to:

• A gamma camera or SPECT-capable system
• Nuclear-medicine technologists
• Radiopharmacy support
• Tc-99m supply
• Timely patient scheduling

Hospitals with limited nuclear-medicine staffing may outsource the procedure or use alternative imaging modalities.

How does technetium Tc-99m mebrofenin compare with competing imaging agents?

Mebrofenin competes indirectly with other imaging approaches more than with another branded pharmaceutical.

Option	Main advantage	Main limitation
Tc-99m mebrofenin HIDA scan	Functional hepatobiliary assessment	Requires radiopharmaceutical supply and nuclear-medicine infrastructure
Ultrasound	Low cost, broad availability	Operator dependence; limited functional information
CT	Fast and widely available	Radiation exposure; less direct gallbladder function assessment
MRCP	Strong anatomic detail and no ionizing radiation	Higher cost, longer scan time, MRI access
ERCP	Diagnostic and therapeutic capability	Invasive and complication risk

The product's competitive position is strongest when physicians require dynamic information about cystic-duct patency, bile flow, or gallbladder function. It is weaker when rapid anatomic imaging is sufficient.

What is the financial trajectory of the product?

The financial trajectory is mature, stable, and low-growth rather than expansionary.

Public company filings generally do not isolate Choletec revenue from broader diagnostic-imaging or radiopharmaceutical sales. The product should therefore be modeled using operational indicators rather than a standalone reported revenue series.

Revenue drivers

1. HIDA procedure volume. More hospital and emergency-department procedures directly increase demand for kits and labeled doses.
2. Unit pricing. Price increases can support revenue, but procurement organizations may resist increases because the product is a mature diagnostic agent.
3. Radiopharmacy contracts. Multi-site contracts can provide recurring demand but may compress margins.
4. Supply reliability. Shortages can cause temporary revenue loss and encourage hospitals to use alternative imaging.
5. Hospital case mix. Emergency and surgical volumes affect testing demand.
6. Tc-99m economics. Generator and isotope costs affect the total cost of the labeled dose.
7. Manufacturing utilization. A mature kit has better economics at stable production volumes, but the absolute market remains limited.

Financial outlook

Period	Expected market behavior
Near term	Stable demand tied to HIDA volumes and radiopharmacy contracts
Medium term	Low single-digit structural growth at most, with regional variation
Downside case	Volume declines from ultrasound substitution, hospital budget pressure, or supply disruption
Upside case	Higher emergency-care volumes, improved radiopharmacy coverage, or competitor shortages
Long term	Mature product with limited pricing power and no major patent-driven growth event

The product is unlikely to generate therapeutic-drug-level growth. Its financial value lies in recurring procedure demand, relatively predictable clinical use, and the operational difficulty of maintaining a reliable radiopharmaceutical supply chain.

What licensing deals affect technetium Tc-99m mebrofenin?

No major publicly disclosed licensing transaction appears to define the current U.S. market for technetium Tc-99m mebrofenin.

The commercially relevant arrangements are more likely to be:

• Manufacturer-to-radiopharmacy supply agreements
• Hospital group purchasing contracts
• Distribution agreements
• Contract manufacturing arrangements
• Generator and isotope supply contracts
• Regional nuclear-pharmacy partnerships

These agreements are often private and may not identify product-level economics. Licensing is therefore less important than distribution access and manufacturing continuity.

What manufacturing and intellectual-property barriers exist?

The main barriers are manufacturing and compliance controls rather than active patent claims.

A competitor must establish:

• Sterile vial filling
• Validated lyophilized or nonradioactive kit production
• Radiochemical labeling performance
• Endotoxin and sterility controls
• Stability under expected storage conditions
• Packaging and labeling compliant with radioactive-drug use
• Consistent supply of Tc-99m through radiopharmacy partners
• Pharmacovigilance and product-quality systems

Tc-99m availability creates a separate supply risk. The isotope is produced from molybdenum-99 generators and is affected by reactor operations, processing capacity, transportation, and regional distribution. The U.S. government has supported domestic molybdenum-99 supply resilience because isotope shortages can affect multiple diagnostic radiopharmaceuticals. [3]

What generic launch risks exist?

A future abbreviated applicant would face a moderate regulatory and commercial launch risk.

Risk	Impact
Small addressable market	Limits return on development and launch investment
Sterile manufacturing failure	Can delay approval or trigger supply interruptions
Radiopharmacy adoption	Requires validated preparation workflows
Contracting pressure	May reduce price and margins
Alternative imaging	Restricts long-term volume growth
Tc-99m shortages	Can interrupt product use regardless of kit availability
Limited brand loyalty	Supports substitution after approval
Low product visibility in public filings	Complicates market sizing and valuation

Generic entry could reduce price, but the effect may be gradual. Radiopharmacies may value supply reliability more than the lowest nominal kit price, particularly where a failed preparation can waste isotope, delay procedures, and disrupt clinical schedules.

What litigation and settlement issues affect the market?

No major active patent litigation or settlement agreement is widely associated with the current Choletec market. The absence of prominent litigation is consistent with the product's mature exclusivity position and relatively limited commercial value.

The legal issues most relevant to market participants are more likely to involve:

• FDA manufacturing inspections
• Product-quality investigations
• Supply interruptions
• Contract disputes
• False-claims or reimbursement issues
• Radiation-safety compliance
• Hospital purchasing agreements

These risks can affect revenue without changing patent status.

How does technetium Tc-99m mebrofenin compare with newer radiopharmaceutical markets?

Mebrofenin is a mature diagnostic agent with limited pricing power. It differs from newer radiopharmaceutical categories such as prostate-specific membrane antigen imaging and targeted radioligand therapy.

Attribute	Tc-99m mebrofenin	Newer targeted radiopharmaceuticals
Clinical role	Diagnostic hepatobiliary imaging	Diagnostic or therapeutic targeted imaging
Patent position	Mature	Often active and substantial
Pricing power	Limited	Potentially high
Market growth	Procedure-linked and modest	Can be rapid after clinical adoption
Manufacturing risk	Sterile kit and isotope logistics	Complex isotope, ligand, and facility requirements
Reimbursement	Established diagnostic pathways	Evolving and indication-specific
Competitive intensity	Generic and modality substitution	Patent, platform, and clinical differentiation

Mebrofenin is a dependable mature-product business, not a high-growth precision-medicine asset.

Key Takeaways

• Technetium Tc-99m mebrofenin is a mature diagnostic radiopharmaceutical kit used mainly for HIDA imaging.
• Choletec is the established U.S. reference product associated with Bracco Diagnostics.
• Core patent and regulatory exclusivity are not the main sources of current market protection.
• No biosimilar pathway applies; later competitors would be generic or abbreviated drug products.
• Publicly disclosed product-level revenue is limited, so financial analysis depends on procedure volume, pricing, contracts, and supply reliability.
• HIDA procedure demand is supported by acute-care use but constrained by ultrasound, CT, and MRCP substitution.
• Manufacturing validation, radiopharmacy distribution, sterile quality systems, and Tc-99m access are the principal entry barriers.
• The expected financial trajectory is stable to low-growth, with downside risk from substitution and isotope shortages.
• No major current Paragraph IV litigation, patent settlement, or market-defining licensing deal is publicly associated with the product.

FAQs

Is technetium Tc-99m mebrofenin a generic drug?

It is a mature diagnostic drug product supplied as a kit. Competing products would generally use an abbreviated approval pathway, but the product is not a biologic and does not have a biosimilar pathway.

Who markets Choletec in the United States?

Choletec is associated with Bracco Diagnostics, a major radiopharmaceutical supplier. Product distribution can involve radiopharmacies and regional nuclear-medicine channels.

Can ultrasound replace a HIDA scan?

Ultrasound can replace HIDA imaging in some patients, particularly when the diagnosis is clear. HIDA remains useful when functional gallbladder or biliary information is required or when ultrasound findings are inconclusive.

Does Tc-99m mebrofenin have strong pricing power?

No. It is a mature diagnostic product exposed to hospital purchasing pressure, generic competition, procedure substitution, and radiopharmacy contracting.

What is the largest commercial risk for the product?

The largest practical risks are loss of procedure volume, supply disruption, and manufacturing or radiopharmacy failures. Patent expiration is not the central current risk.

References

1. U.S. Food and Drug Administration. (n.d.). Choletec: Kit for the preparation of technetium Tc 99m mebrofenin injection prescribing information. Bracco Diagnostics.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.

3. U.S. Department of Energy, National Nuclear Security Administration. (n.d.). Molybdenum-99 and medical isotope supply.

4. Society of Nuclear Medicine and Molecular Imaging. (n.d.). SNMMI procedure standard for hepatobiliary scintigraphy.

5. National Institute of Biomedical Imaging and Bioengineering. (n.d.). Nuclear medicine and molecular imaging. National Institutes of Health.