Fluorodopa f-18 - Generic Drug Details

What are the generic sources for fluorodopa f-18 and what is the scope of patent protection?

Fluorodopa f-18 is the generic ingredient in one branded drug marketed by Feinstein and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for fluorodopa f-18

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	13
DailyMed Link:	fluorodopa f-18 at DailyMed

Recent Clinical Trials for fluorodopa f-18

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

Sponsor	Phase
Mayo Clinic	PHASE2
Andrew Newberg	Phase 2
Thomas Jefferson University	Phase 2

See all fluorodopa f-18 clinical trials

US Patents and Regulatory Information for fluorodopa f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Feinstein	FLUORODOPA F18	fluorodopa f-18	SOLUTION;INTRAVENOUS	200655-001	Oct 10, 2019		RX	Yes	Yes

Fluorodopa F-18 Market Dynamics, FDA Status, Patent Position and Financial Trajectory

Last updated: September 12, 2026

Fluorodopa F-18 is a short-lived PET radiopharmaceutical used primarily to image presynaptic dopaminergic function in patients with suspected Parkinsonian syndromes. Its commercial opportunity is limited by radiopharmaceutical logistics, specialist demand and competition from established clinical diagnosis and ioflupane I-123 imaging. Public disclosures do not provide standalone revenue for fluorodopa F-18, so its financial trajectory is best assessed through procedure volume, supplier reach, reimbursement and manufacturing economics rather than product sales.

What is fluorodopa F-18 used for?

Fluorodopa F-18, also called 6-[18F]fluoro-L-DOPA or F-DOPA, is an amino-acid analogue labeled with fluorine-18. PET imaging measures its uptake and conversion in the striatal dopaminergic system.

The U.S. FDA-approved indication is PET imaging of dopaminergic neurons in the striatum to evaluate adults with suspected Parkinsonian syndromes. The imaging result supports diagnosis but does not independently establish a specific Parkinson disease subtype or determine disease progression.[1]

F-DOPA also has clinical and commercial use outside the U.S. for selected neuroendocrine tumors, pheochromocytoma, paraganglioma and brain-tumor applications. These uses depend on local regulatory approvals, institutional protocols and reimbursement rules. They should not be treated as equivalent to the U.S. FDA-labeled indication.

Key product characteristics

Attribute	Fluorodopa F-18
Active imaging agent	6-[18F]fluoro-L-DOPA
Modality	Positron emission tomography
Primary U.S. use	Imaging striatal dopaminergic neurons
Half-life of fluorine-18	Approximately 110 minutes
Main clinical target	Suspected Parkinsonian syndromes
Administration	Intravenous injection
Supply model	Regional or local radiopharmacy production and distribution
Primary commercial constraint	Time-sensitive manufacturing and delivery
Major competing technology	Ioflupane I-123 SPECT, marketed as DaTscan
Revenue disclosure	No widely reported standalone product revenue

When did fluorodopa F-18 receive FDA approval?

The FDA approved fluorodopa F-18 injection for PET imaging of striatal dopaminergic neurons in 2019.[1] The approval established a U.S. regulatory pathway for clinical use but did not create the same commercial profile as a conventional chronic pharmaceutical.

Fluorodopa F-18 is administered for a diagnostic procedure rather than taken repeatedly over a treatment course. Revenue depends on the number of scans performed, the radiopharmacy supply price and the reimbursement collected by the imaging provider.

The product’s clinical value is strongest when a neurologist needs to distinguish a degenerative Parkinsonian syndrome from conditions such as essential tremor, drug-induced Parkinsonism or other movement disorders. In many patients, diagnosis remains clinical, reducing the addressable population.

FDA regulatory status

The FDA labeling describes the product as an imaging agent, with dosing and handling requirements linked to its radioactive decay profile. The label requires appropriate radiation-safety controls and recognizes the need for trained personnel and specialized equipment.[1]

The principal regulatory risks are operational rather than clinical-development risks:

• Maintaining drug quality through short production-to-administration windows.
• Complying with radioactive-material handling rules.
• Establishing validated synthesis, sterility and release procedures.
• Preserving availability across weekends, holidays and geographically dispersed sites.
• Demonstrating reliable supply to hospitals and PET centers.

Unlike a therapeutic drug, fluorodopa F-18 does not require a large outcome-trial program to support recurring use after approval. Market growth therefore depends more heavily on physician adoption, payer coverage and site economics.

What is the Orange Book status of fluorodopa F-18?

No material Orange Book patent barrier is associated with the FDA-approved fluorodopa F-18 product in the public regulatory records cited here. The FDA Orange Book is the principal U.S. source for approved drug-product patent listings and exclusivity information.[2]

The active ingredient and core radiochemistry are based on long-established scientific methods. Fluorine-18 has a short half-life, and the underlying chemistry is not comparable to a recently discovered small-molecule therapeutic with a long remaining patent term.

The commercial protection available to a supplier is more likely to come from:

• Local manufacturing licenses.
• Radiopharmacy distribution infrastructure.
• Quality systems and validated production processes.
• Hospital contracts.
• Scheduling integration with PET centers.
• Proprietary automation or synthesis equipment.
• Brand and service reliability.

How strong is the patent estate for fluorodopa F-18?

The patent estate appears weak as a product-level exclusion strategy. The core active ingredient is old, and no clear, broad U.S. composition-of-matter patent creates a durable barrier around fluorodopa F-18.

Potentially relevant patent categories include:

1. Radiochemical synthesis patents. These may cover precursor chemistry, labeling conditions or purification.
2. Manufacturing patents. These may concern automated modules, cassette systems or sterile production.
3. Formulation patents. These may cover stabilizers, buffers, container systems or quality-control methods.
4. Imaging-method patents. These could address disease-specific interpretation or combinations with other imaging techniques.
5. Software and workflow rights. These may cover image processing or quantitative PET analysis.

Such rights are narrower than a basic composition patent and may be difficult to enforce against a radiopharmacy that uses a different synthesis route.

When does fluorodopa F-18 lose exclusivity?

Fluorodopa F-18 has no conventional loss-of-exclusivity event comparable to a blockbuster drug with a defined patent cliff. The main active ingredient and fundamental imaging concept predate the U.S. approval by decades.

Any FDA regulatory exclusivity attached to the approved product would be separate from patent protection and would not prevent all competing production routes indefinitely. Publicly available product information does not indicate a significant remaining U.S. exclusivity period that would block competing fluorodopa F-18 suppliers on a broad basis.

The practical entry question is whether a new supplier can manufacture and distribute a sterile radioactive product consistently. A competitor does not need to overcome a major patent wall, but it does need:

• FDA-compliant manufacturing capability.
• Access to fluorine-18 production.
• An approved or otherwise authorized regulatory pathway.
• A qualified radiopharmacy network.
• PET-center demand sufficient to support production economics.

Are there Paragraph IV challenges to fluorodopa F-18?

No major publicly reported Paragraph IV litigation has defined the U.S. market for fluorodopa F-18. Paragraph IV litigation is more common for conventional drug products with Orange Book-listed patents and commercial generic substitution.

Fluorodopa F-18 has a different competitive structure. A new supplier would more likely pursue its own regulatory approval and manufacturing pathway than challenge a dominant patent estate. The absence of a visible Paragraph IV dispute is consistent with the product’s limited patent barriers and specialized radiopharmaceutical market.

This does not eliminate regulatory competition. Suppliers may compete through new drug applications, abbreviated regulatory pathways where available, hospital contracting and regional production capacity.

What formulations are protected by fluorodopa F-18 patents?

No widely recognized formulation patent has established a broad U.S. market barrier around the standard fluorodopa F-18 injection. The commercial formulation is generally a sterile aqueous injectable solution prepared for immediate or near-term clinical use.

Formulation differentiation has limited economic value because the product decays rapidly. A formulation that extends chemical shelf life does not eliminate the 110-minute physical half-life of fluorine-18. The higher-value technical protections are therefore likely to involve:

• Faster synthesis.
• Higher radiochemical yield.
• Lower impurity levels.
• More reliable automated production.
• Improved sterility assurance.
• Reduced operator exposure.
• Better delivery scheduling.

Manufacturing know-how can have more commercial importance than formulation exclusivity.

How does fluorodopa F-18 compare with DaTscan?

DaTscan, containing ioflupane I-123, is the closest widely recognized U.S. imaging competitor for assessing striatal dopamine-transporter abnormalities. It uses SPECT rather than PET and has a different isotope, workflow and reimbursement profile.[3]

Category	Fluorodopa F-18	DaTscan
Imaging modality	PET	SPECT
Radiotracer	6-[18F]fluoro-L-DOPA	Ioflupane I-123
Main use	Striatal dopaminergic function	Striatal dopamine-transporter imaging
Infrastructure	PET scanner and F-18 supply	SPECT scanner and I-123 supply
Physical half-life	About 110 minutes	About 13 hours
Distribution	Highly time-sensitive	More flexible distribution
Clinical familiarity	Stronger in specialist and international settings	Established U.S. commercial presence
Manufacturing burden	High because of short half-life	Lower distribution pressure
Competitive strength	PET resolution and dopaminergic biochemistry	Established availability and physician familiarity

F-DOPA can offer higher spatial resolution and direct assessment of dopamine synthesis and storage pathways. DaTscan benefits from longer isotope half-life, broader commercial familiarity and easier distribution. The choice depends on local expertise, clinical question, payer policy and access to PET or SPECT.

What drives the fluorodopa F-18 market?

Clinical demand

Demand is linked to movement-disorder referrals and the number of patients whose diagnosis remains uncertain after neurological examination. Growth is constrained because most Parkinson disease diagnoses are made clinically without mandatory molecular imaging.

The highest-value use cases are likely to include:

• Atypical or early Parkinsonian presentations.
• Diagnostic uncertainty between essential tremor and Parkinsonism.
• Drug-induced or vascular Parkinsonism.
• Research and clinical-trial biomarker applications.
• Specialist movement-disorder centers.

PET infrastructure

F-DOPA requires access to PET imaging and a nearby fluorine-18 production source. Large academic medical centers and metropolitan PET networks are better positioned than rural hospitals.

The short half-life creates a radius problem. A supplier must coordinate cyclotron production, radiochemistry, quality release, dispatch and patient appointment timing. Missed appointments can create direct product waste because unused activity loses value rapidly.

Reimbursement

Reimbursement is a central commercial variable. Even where a scan is clinically appropriate, coverage may vary by payer, indication and coding policy. Hospitals may evaluate the procedure based on total contribution margin rather than the radiopharmaceutical acquisition price alone.

The economic model includes:

• Radiotracer acquisition cost.
• PET scanner time.
• Technologist and physician labor.
• Radiation-safety compliance.
• Patient scheduling and no-show risk.
• Radiopharmacy delivery cost.
• Payer denial or underpayment risk.

What is the financial trajectory for fluorodopa F-18?

No reliable public source reports global or U.S. standalone revenue for fluorodopa F-18. Suppliers generally disclose broader radiopharmaceutical, imaging or healthcare revenue rather than product-level sales.

The likely financial trajectory is gradual and procedure-driven:

Period	Commercial condition	Financial implication
Launch and early adoption	Limited sites, specialist education and reimbursement development	Low initial revenue, high setup burden
Network expansion	More PET centers and radiopharmacy coverage	Volume growth with regional density
Mature market	Stable use in diagnostic uncertainty and specialist centers	Predictable but niche procedure revenue
Competitive pressure	Alternative tracers and improved clinical diagnosis	Pricing pressure and slower volume growth
International expansion	Wider neuroendocrine and neurologic use where approved	Potentially broader demand than U.S. labeling

The product is unlikely to generate blockbuster pharmaceutical revenue without a substantial expansion in indications or routine use. Its economic profile resembles a specialized imaging service more than a chronic prescription medicine.

Revenue exposure for manufacturers

Supplier revenue is exposed to five variables:

1. Dose volume. Each scan usually generates one time-sensitive patient dose.
2. Geographic density. Dense PET networks improve utilization and reduce failed deliveries.
3. Production reliability. A single cyclotron or synthesis failure can eliminate a day’s revenue.
4. Reimbursement. Coverage determines whether hospitals continue ordering the product.
5. Competitive substitution. DaTscan, FDG PET and clinical diagnosis limit share expansion.

A supplier with an existing F-18 network can have a lower incremental cost than a new entrant. Existing infrastructure also supports cross-selling of FDG, amyloid, tau and other PET products.

Which companies are challenging the fluorodopa F-18 market?

Competition is fragmented rather than concentrated in one branded global rival. Potential competitors include:

• Radiopharmaceutical manufacturers with regional cyclotron networks.
• Academic medical centers producing F-DOPA under applicable regulatory frameworks.
• Contract radiopharmacies.
• PET-network operators.
• Suppliers of DaTscan and other dopaminergic imaging agents.
• Diagnostic developers pursuing novel PET or SPECT biomarkers.

The competitive advantage is operational. A company with a validated production site near high-volume PET centers can compete effectively even without strong patent protection.

What patent litigation and settlement risks exist?

No major publicly reported U.S. patent litigation or settlement agreement has materially restricted fluorodopa F-18 competition. The more relevant disputes would likely involve:

• Manufacturing process patents.
• Trade secrets related to precursor production.
• Regulatory exclusivity.
• Supply agreements with hospitals.
• Radiopharmacy licensing.
• Failed or delayed product release.
• Contractual restrictions on regional distribution.

Because the core active ingredient is old, litigation risk is more likely to arise from process or commercial agreements than from a blocking composition patent.

What generic launch scenarios exist for fluorodopa F-18?

A conventional generic launch is not the most useful framework. The likely scenarios are:

Scenario 1: Regional manufacturing entry

A new supplier establishes production near large PET markets. It competes on reliability, price and delivery coverage. This is the most plausible entry route.

Scenario 2: Hospital-based production

Academic centers expand internal radiopharmacy capabilities. This may reduce purchases from commercial suppliers but is limited by capital, staffing and regulatory requirements.

Scenario 3: Platform supplier expansion

A company already producing F-18 radiopharmaceuticals adds fluorodopa F-18 to its portfolio. This strategy has the strongest infrastructure economics.

Scenario 4: Clinical substitution

Neurologists use clinical diagnosis, DaTscan or another PET tracer instead of F-DOPA. This limits market growth without requiring a competing fluorodopa product.

What are the main manufacturing and IP barriers?

The most important barriers are operational:

• Cyclotron access.
• F-18 target production.
• Precursor supply.
• Automated synthesis equipment.
• Sterile compounding.
• Rapid quality control.
• Radiation-safety systems.
• Trained radiochemists and nuclear-medicine staff.
• Reliable delivery routes.
• Patient scheduling at PET centers.

These barriers can support regional pricing power even when patent protection is limited. They do not create durable global exclusivity, because a well-capitalized radiopharmacy or hospital network can replicate the production model.

Key Takeaways

• Fluorodopa F-18 is an FDA-approved PET imaging agent for evaluating striatal dopaminergic neurons in suspected Parkinsonian syndromes.
• Its commercial market is specialized and procedure-driven rather than comparable to a chronic pharmaceutical market.
• No major U.S. patent cliff, Paragraph IV campaign or litigation settlement currently defines competition.
• The core commercial moat is radiopharmacy infrastructure, not composition-of-matter patent protection.
• DaTscan is the principal established U.S. imaging competitor, with advantages in isotope half-life and distribution flexibility.
• Public sources do not disclose standalone fluorodopa F-18 revenue.
• Financial growth depends on PET-center adoption, diagnostic uncertainty, reimbursement, regional manufacturing density and supply reliability.
• The most credible competitive threat is regional or platform-based radiopharmacy entry, followed by clinical substitution.

FAQs About Fluorodopa F-18

Is fluorodopa F-18 a treatment for Parkinson disease?

No. It is a diagnostic PET imaging agent used to evaluate striatal dopaminergic function. It does not treat Parkinson disease or slow disease progression.

Is fluorodopa F-18 the same as DaTscan?

No. Fluorodopa F-18 is an F-18 PET tracer based on fluoro-L-DOPA. DaTscan is an I-123 SPECT tracer containing ioflupane. They assess related dopaminergic abnormalities through different imaging mechanisms.

Can fluorodopa F-18 be used for neuroendocrine tumors?

It is used for selected neuroendocrine tumor and pheochromocytoma imaging applications in some jurisdictions. The applicable indication depends on local regulatory approval and institutional practice.

Why is fluorodopa F-18 difficult to distribute nationally?

Fluorine-18 has a physical half-life of about 110 minutes. Production, quality release, transport and administration must occur within a narrow operating window, making local or regional supply networks essential.

Does fluorodopa F-18 have biosimilar risk?

No. Biosimilar regulation applies to biological products. Fluorodopa F-18 is a radiolabeled small-molecule diagnostic agent. Competition is more likely to come from alternative radiopharmaceutical suppliers and imaging modalities.

References

1. U.S. Food and Drug Administration. (2019). Fluorodopa F 18 injection prescribing information. FDA. https://www.accessdata.fda.gov
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
3. U.S. Food and Drug Administration. (2011). DaTscan prescribing information. FDA. https://www.accessdata.fda.gov/drugsatfda/