AXUMIN Drug Patent Profile

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

Axumin is a drug marketed by Blue Earth and is included in one NDA. There are eight patents protecting this drug.

The generic ingredient in AXUMIN is fluciclovine f-18. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fluciclovine f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Axumin

Axumin was eligible for patent challenges on May 27, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 28, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AXUMIN

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	26
Patent Applications:	127
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AXUMIN
What excipients (inactive ingredients) are in AXUMIN?	AXUMIN excipients list
DailyMed Link:	AXUMIN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AXUMIN

Constraining patent/regulatory exclusivity:

10,010,632

NDA:

208054

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for AXUMIN

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

Sponsor	Phase
VA Greater Los Angeles Healthcare System	PHASE4
Dana-Farber Cancer Institute	Phase 1
Oregon Health and Science University	Phase 4

See all AXUMIN clinical trials

Pharmacology for AXUMIN

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for AXUMIN

AXUMIN is protected by eight US patents.

This potential generic entry date is based on patent 10,010,632.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,124,079
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,933,147
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,716,868

Expired US Patents for AXUMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016	5,808,146

International Patents for AXUMIN

When does loss-of-exclusivity occur for AXUMIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

European Patent Office

Poland

Russian Federation

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AXUMIN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2006319987	Precursor compound of radioactive halogen labeled organic compound
Brazil	PI0619213	composto precursor de composto orgánico marcado com haloênio radioativo
Canada	2629227	COMPOSE PRECURSEUR DE COMPOSE ORGANIQUE MARQUE A L'HALOGENE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND)

Last updated: June 22, 2026

AXUMIN (fluciclovine F 18): Market dynamics and financial trajectory since launch

Executive summary: AXUMIN (fluciclovine F 18) has remained a niche, high-value PET tracer with constrained addressable use, concentrated reimbursement economics, and a highly regulated supply chain. Commercial performance is driven by (1) prostate cancer imaging adoption under Medicare coverage rules and payer policy, (2) imaging-center throughput economics and tracer logistics, and (3) competitive pressure from other PET tracers and shifting clinical practice. Financial trajectory has followed a typical orphan/limited-market imaging pattern: steady growth tied to site adoption, then more modest expansion as utilization matures and payer coverage becomes the gating factor.

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What is AXUMIN’s market size and demand profile in PET imaging for prostate cancer?

AXUMIN is a fluorine-18 labeled amino acid PET imaging agent used for imaging suspected prostate cancer recurrence, including in the setting of biochemical recurrence after primary treatment. Demand is not “population-scaled” like blockbuster oral therapies; it is driven by:

• Number of eligible imaging sites (PET centers with cyclotron and radiochemistry capability or outsourced production access).
• Scheduling and throughput economics (short shelf-life and cold-chain constraints can cap daily volumes at a facility).
• Coverage and reimbursement (payer policies determine whether scans get approved and coded consistently).
• Clinical pathway adoption (referral patterns from urology and oncology determine whether AXUMIN is the default tracer).

Where does utilization concentrate?

Utilization concentrates in:

• High-volume academic and regional PET centers that can generate consistent case volume.
• Geographies where Medicare local coverage determinations (LCDs) and managed-care policies support PET imaging indications.
• Practices with established workflows for tracer handling and protocol adherence.

What drives case volume per site?

• Expected detectability in target patient subgroups (patients with rising PSA where imaging is most likely to change management).
• Turnaround time and reporting capacity (radiologist reads and downstream therapy planning).
• Institutional experience with amino acid PET interpretation.

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How do reimbursement and Medicare coverage shape AXUMIN revenue?

Featured snippet answer: AXUMIN’s revenue trajectory is structurally tied to payer acceptance of PET imaging for biochemical recurrence indications and to whether reimbursement is stable and predictable at the coding and claims level.

Medicare and payer policy impact

For imaging products like AXUMIN, payer coverage often becomes the limiting factor. Even when clinical demand exists, reimbursement rules determine:

• Whether a scan is approved for the patient’s disease state.
• Whether repeat imaging is covered after prior scans.
• Whether prior authorization is required (time friction reduces utilization).

Commercial pricing mechanics

Unlike therapeutics with broad insurer negotiation cycles, imaging agents behave like per-dose commodities. Revenue depends on:

• Units shipped (vials/flasks converted to doses per labeling configuration).
• Net price after rebates/contracting with large imaging networks and specialty distributors.
• Geographic mix of reimbursed volume.

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When does AXUMIN face utilization headwinds from competing PET tracers?

AXUMIN is in a competitive PET tracer category where oncology imaging adoption can pivot quickly based on clinician preference, payer coverage, and clinical evidence.

Competitive pressure map (practical dynamics)

• PSMA-targeted PET agents (in prostate cancer) have broadly expanded adoption in many practices due to strong performance characteristics and growing payer comfort.
• Other amino acid PET tracers compete indirectly on “why this tracer over that tracer” within biochemical recurrence pathways.

What shifts the tracer “default” at a site?

• Reimbursement parity or better for competing tracers under the same payer contracts.
• Higher positivity rates in real-world case mix leading to higher downstream referral satisfaction.
• Operational simplification if a site stocks a single tracer inventory.
• Radiologist and referring clinician learning curve for image interpretation.

Result for AXUMIN commercial trajectory

AXUMIN’s financial path is likely to show:

• Slower growth than PSMA-centric options as adoption shifts.
• Residual strength where amino acid PET remains preferred or better covered, including protocols that align with the evidence base and local payer patterns.

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What does AXUMIN’s financial trajectory likely look like: launch ramp, maturity, and plateau?

Featured snippet answer: AXUMIN’s financial profile has fit a ramp-and-mature pattern typical of radiopharmaceutical imaging products: early site adoption lifts revenue, then growth moderates as the addressable set of reimbursed, high-throughput imaging volumes saturates.

How imaging drugs monetize versus therapeutics

Revenue is driven by:

• Dose consumption, not chronic dosing.
• Site adoption cycles (a center converts protocols, trains staff, and stabilizes referral streams).
• Claim-level reimbursement stability.

Key phases

1. Launch ramp (initial adoption):
   • New ordering patterns.
   • Early payer acceptance creates early demand spikes.
2. Maturity:
   • More centers can order, but case mix and reimbursement friction constrain incremental volume.
   • Competitive switching reduces the growth rate.
3. Plateau or modest decline (if competition dominates):
   • Units stabilize; pricing becomes the swing factor.
   • Contracting and rebate pressure compress net revenue.

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How strong is AXUMIN’s patent and exclusivity moat versus generic or replacement products?

Featured snippet answer: AXUMIN’s competitive threat is mostly “replacement by other tracers” rather than generic substitution. For radiopharmaceuticals, practical substitution is tied to regulatory approval pathways and manufacturing qualification, not simple generic exchange.

What protects AXUMIN commercially?

• Regulatory exclusivity and approved indications can support pricing power early.
• Patent estate coverage across:
  • synthesis and labeling chemistry,
  • formulation and container systems,
  • and method-of-use.

In practice, even where patents expire, a tracer can face speed bumps from:

• manufacturing validation,
• GMP release systems,
• supply chain quality and radionuclide sourcing,
• and payer/provider confidence.

Biosimilar-style threats

No biosimilar concept applies to small-molecule PET tracers in the same way as biologics. The analog threat is label expansions by competitors or new tracer approvals that capture the same clinical decision points.

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What is AXUMIN’s FDA regulatory position and how does it affect commercial outcomes?

Featured snippet answer: AXUMIN’s commercial ceiling tracks how tightly its FDA-approved use lines up with payer-covered clinical scenarios.

Approval-linked utilization

Regulatory scope affects:

• patient selection,
• protocol standardization,
• and insurer willingness to cover.

Label changes and utilization

Any label expansion or updated indication guidance can improve:

• clinician comfort,
• payer coverage negotiations,
• and willingness to add AXUMIN to tracer menus at imaging centers.

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What is the Orange Book status of AXUMIN and what does it imply for competition?

Featured snippet answer: AXUMIN is a radiopharmaceutical product; Orange Book listings, if present, indicate generic-substitution-relevant patent coverage but do not eliminate competitive substitution by other approved PET tracers.

What to expect from Orange Book dynamics

• If key patents expire later than market maturity timelines, legal exclusivity helps sustain pricing and supply.
• If patents are narrow (chemistry or specific claim scopes), competitors can still compete via different approved tracers without needing to “design around” AXUMIN’s claim set.

(Orange Book is product- and listing-specific; AXUMIN’s competitive reality in practice is more influenced by imaging-tracer adoption than by generic entry feasibility.)

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Which companies supply AXUMIN, and how do manufacturing and supply constraints influence revenue?

Featured snippet answer: AXUMIN revenue is sensitive to production capacity, radiochemistry scheduling, and distributor allocation because radiopharmaceutical supply must be continuous enough to match imaging center demand.

Commercial supply chain realities

• Short effective window from production to imaging use limits “inventory buffering.”
• Production outages or radionuclide sourcing disruptions can cause missed orders, lost claims, and longer resupply timelines.
• Regional distribution and cold logistics determine whether centers can maintain scanning schedules.

Why supply can cap growth

Even with demand, revenue can underperform if:

• a facility cannot reliably schedule doses,
• distributor allocation restricts access,
• or cold-chain and radiochemistry handling impose administrative friction.

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How do reimbursement cuts, rebate pressure, or net price compression affect AXUMIN margins and earnings?

Featured snippet answer: For per-dose imaging agents, net price is the primary lever when utilization growth slows.

What happens at maturity

• Increased competition leads to more aggressive contracting and rebates.
• Net price declines can occur even if gross pricing stays stable.
• Sales effectiveness changes as “traditional AXUMIN pathways” become narrower.

Margin structure sensitivity

Radiopharmaceutical gross margins depend on:

• production efficiency,
• logistics costs,
• waste and reprocessing,
• and on-time delivery performance.

Missed deliveries can reduce conversion of orders into billed doses.

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What generic entry risks exist for AXUMIN, and are they the primary threat?

Featured snippet answer: Generic substitution risk is usually not the dominant threat for AXUMIN-like tracers; the dominant threat is clinical and payer-driven switching to other approved PET tracers.

If generic entry occurs, what would it take?

• regulatory approval for equivalent product characteristics,
• manufacturing readiness for radiolabeling,
• and payer acceptance to cover the switch.

Competitive replacement remains the faster channel

Even absent generic AXUMIN, a center can switch to:

• a competitor PET tracer,
• an alternate clinical protocol, or
• a new tracer with stronger evidence adoption.

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How does AXUMIN compare with PSMA PET tracers on market dynamics and payer behavior?

Featured snippet answer: PSMA PET tracers generally have benefited from broader clinical adoption and payer comfort, which can reduce AXUMIN’s incremental share in the same biochemical recurrence decision points.

Side-by-side dynamic factors that matter commercially

• Payer coding and prior authorization ease
• Image interpretability in real-world reads
• Protocol standardization across networks
• Ordering convenience (single-tracer inventory preference)

Commercial consequence for AXUMIN

• Slower top-line growth due to competitive switching.
• More reliance on strongholds where amino acid PET stays favored or payer coverage is relatively stable.

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Key litigation and exclusivity disputes: what patent challenges affect AXUMIN?

Featured snippet answer: The main competitive disruption for imaging tracers typically comes through alternative approvals rather than generic patent challenges. Litigation risk can still affect exclusivity and market access, but the commercial storyline is more commonly shaped by payer and clinical switching.

(A litigation-by-litigation impact map requires specific case dockets, settlement terms, and Orange Book listed patents; without those case-level records, the impact cannot be stated accurately.)

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Commercial timeline: how AXUMIN’s market position typically evolves over a product life cycle

Expected timeline pattern (high-level)

• Year 0-2: Adoption ramp in PET centers; reimbursement establishment; initial utilization sensitivity to payer policy.
• Year 2-5: Growth becomes constrained; competition begins shifting tracer defaults; price becomes the lever.
• Year 5+: Market stabilizes in pockets; incremental volumes depend on coverage changes or label expansion; margins depend on net price and delivery efficiency.

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Key Takeaways

• AXUMIN’s commercial performance is structurally tied to reimbursed PET utilization, not chronic dosing scale.
• Demand concentrates in high-throughput imaging networks where logistics and turnaround economics work.
• The biggest market dynamic is tracer switching toward competing PET agents, particularly where payer coverage and clinical adoption favor alternative modalities.
• Revenue trajectory typically follows a launch ramp to maturity plateau as payer gating and site adoption saturate.
• Competitive pressure primarily comes from approved tracer replacements, with generic substitution risk usually secondary.

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FAQs

1. What patient populations create the highest AXUMIN scan utilization?
2. How do prior authorization requirements change AXUMIN ordering behavior at imaging centers?
3. What logistics constraints most often limit AXUMIN dosing volume per PET site?
4. How does reimbursement variation by payer and geography affect AXUMIN net revenue?
5. What operational indicators predict whether a PET center will expand AXUMIN ordering over time?

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References (APA)

1. [No citations available in the provided prompt.]