United States Patent 10,967,077: Scope, Claims, Expiration, Orange Book Status, and Patent Landscape for Axumin

U.S. Patent No. 10,967,077 protects a tightly defined clinical-use protocol for anti-[18F]fluciclovine, also called anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid or [18F]-FACBC. The independent claim is not a broad composition or manufacturing claim. It covers a specific PET imaging workflow for suspected recurrent prostate cancer, including dose, fasting, exercise restrictions, patient positioning, scan timing, scan direction, and total scan duration.

The patent is commercially relevant to Axumin, the FDA-approved [18F]-fluciclovine PET diagnostic marketed by Blue Earth Diagnostics, a Bracco company. Its principal enforcement value is protocol-based: a competing radiopharmaceutical provider, imaging center, or healthcare operator would face risk only if the accused method practices every material limitation of the asserted claim.

What does U.S. Patent 10,967,077 protect?

Patent 10,967,077 protects a method of using anti-[18F]FACBC to image suspected prostate cancer recurrence. Claim 1 requires all of the following:

Claim element	Required limitation
Radiotracer	Anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid, or anti-[18F]FACBC
Patient	Human subject with suspected prostate cancer recurrence
Dose	370 MBq
Administration	Intravenous bolus injection
Flush	Intravenous flush after injection
Food and drink restriction	No food or drink, including water, for at least four hours before injection, except sips of water for medications
Exercise restriction	No significant exercise for at least one day before PET
Position	Supine, with arms above the head
Scan start	Three to five minutes after the injection ends
Scan direction	From at least the proximal thigh to the base of the skull
Scan duration	Up to 30 minutes
Imaging	Acquisition of a PET scan image

Claim 2 adds two diagnostic-analysis limitations. The image must be analyzed for a lesion smaller than 1 cm at a suspicious location, and the lesion must be identified as suspicious for recurrence when [18F]-FACBC uptake is greater than blood-pool uptake.

The claim therefore protects a complete clinical protocol rather than merely the use of fluciclovine as a molecular imaging agent.

What is the claim scope of claim 1?

Claim 1 is a closed, cumulative method claim. Each limitation must be satisfied for literal infringement. The claim does not broadly cover every [18F]-FACBC PET scan or every use of Axumin in recurrent prostate cancer.

Potentially material distinctions include:

A dose materially different from 370 MBq.
Administration that is not an intravenous bolus.
No post-injection intravenous flush.
A scan beginning outside the three-to-five-minute window.
A scan that does not extend from the proximal thigh to the skull base.
A scan exceeding 30 minutes.
Patient positioning other than supine with arms above the head.
Failure to impose the specified fasting or exercise restrictions.

The phrase "a dose of 370 MBq" creates a central literal-infringement issue. Courts may construe the limitation as requiring the specified nominal dose rather than an exact administered activity, particularly because radiopharmaceutical activity naturally varies through decay, preparation, calibration, and injection loss. The prosecution history and specification would control the treatment of dose tolerance.

What additional protection does claim 2 provide?

Claim 2 is narrower than claim 1. It requires both:

A small lesion measuring less than 1 cm at a suspicious location; and
A finding that tracer uptake exceeds blood-pool uptake.

Claim 2 does not cover every interpretation of a PET scan. It focuses on the use of the protocol to evaluate small suspicious lesions. A provider could practice claim 1 without practicing claim 2 if it acquires the image but does not perform the claimed sub-centimeter lesion analysis.

The claim also raises measurement questions. The patent does not, based on the claim text supplied, define the imaging threshold, region of interest, quantitative uptake value, or blood-pool reference location. Those issues would be addressed through the specification, expert testimony, clinical protocols, and the ordinary meaning of "greater than blood pool."

How does U.S. Patent 10,967,077 relate to Axumin?

Axumin is the FDA-approved fluciclovine F 18 injection indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated prostate-specific antigen levels after prior treatment.[1] The FDA prescribing information specifies a 370 MBq dose and directs image acquisition beginning approximately three to five minutes after injection, with imaging from the mid-thigh to the base of the skull and completion within the stated imaging period.[1]

The FDA-approved label also contains patient-preparation instructions concerning fasting and physical activity. Those label directions closely correspond to the limitations in Patent 10,967,077. This alignment increases the patent's practical relevance because standard use of the branded product may follow the claimed protocol.

Patent protection and FDA labeling remain legally separate:

FDA approval does not establish patent validity.
A label does not itself prove that every administration infringes.
Patent infringement depends on the claim construction and actual conduct.
A generic or alternative radiopharmaceutical applicant may attempt to omit or modify claimed method steps.

What is the FDA regulatory status of Axumin?

Axumin received FDA approval on May 27, 2016, under NDA 208054.[2] It is a diagnostic radiopharmaceutical containing fluciclovine F 18 for PET imaging of suspected recurrent prostate cancer.

Regulatory item	Status
Product	Axumin injection
Active ingredient	Fluciclovine F 18
Sponsor at approval	Blue Earth Diagnostics Ltd.
Current corporate ownership	Blue Earth Diagnostics is part of Bracco
FDA pathway	New drug application
NDA	208054
Approval date	May 27, 2016
Therapeutic area	PET imaging for suspected recurrent prostate cancer

Axumin is a small-molecule radiopharmaceutical, not a biologic. A future competitor would generally pursue an abbreviated generic pathway under section 505(j), a 505(b)(2) application, or another applicable drug pathway. Biosimilar approval under the Public Health Service Act is not the relevant pathway.

What is the Orange Book status of U.S. Patent 10,967,077?

The Orange Book is the primary FDA source for patents and regulatory exclusivity associated with approved drug products.[3] Patent 10,967,077 should be evaluated against the current Orange Book listing for Axumin and against the FDA patent-certification records for any abbreviated application.

The relevant legal consequences are:

If listed, the patent may require a Paragraph IV certification from an ANDA applicant.
A timely Paragraph IV notice can support patent litigation by the NDA holder or patent owner.
A listed method-of-use patent may be addressed through a section viii statement if the applicant omits the protected indication or use from its labeling.
A patent listing does not prevent an applicant from challenging validity, enforceability, or infringement.

For a method claim directed to PET imaging in recurrent prostate cancer, the principal regulatory question is whether the claim corresponds to the approved use and whether the patent is listed for the relevant method of use. The Orange Book listing, if any, must be distinguished from other Axumin patents covering composition, preparation, synthesis, or use.

When does Patent 10,967,077 lose exclusivity?

Patent 10,967,077 issued on April 6, 2021. Its controlling expiration date depends on the patent's earliest effective nonprovisional filing date, patent-term adjustment, terminal disclaimers, and any patent-term extension or adjustment recognized in the USPTO record.[4]

A patent issuing from a U.S. application filed after June 8, 1995 generally has a term of 20 years from the earliest effective nonprovisional U.S. filing date, subject to statutory adjustments.[5] A provisional application does not itself begin the 20-year term. The grant date is therefore not the expiration date.

The public patent record should be used to distinguish:

Earliest claimed priority date.
Earliest effective U.S. nonprovisional filing date.
Patent-term adjustment.
Terminal disclaimer, if any.
Patent-term extension under 35 U.S.C. § 156.
Any reissue or post-grant correction.

A practical term estimate based solely on priority information is not sufficient to establish the enforceable expiration date. The USPTO Patent Center term calculation controls.

Does FDA regulatory exclusivity extend beyond the patent?

No. FDA exclusivity and patent term are separate. Axumin's five-year new chemical entity exclusivity began with the 2016 approval and is distinct from Patent 10,967,077. Any pediatric, orphan, or other regulatory exclusivity would require a separate FDA determination.

For a radiopharmaceutical with a 2016 approval, the principal commercial barrier today is likely patent and manufacturing access rather than unexpired NCE exclusivity.

How strong is the patent estate for Axumin?

The strength of Patent 10,967,077 is mixed.

Strengths

The patent has several commercially practical strengths:

The claim tracks the labeled clinical protocol.
It covers administration and imaging conduct that may be performed routinely by authorized imaging centers.
The claim includes multiple operational limitations that can be documented through standard operating procedures, orders, dose records, and PET scanner logs.
Infringement evidence may exist in patient instructions, radiopharmacy records, electronic medical records, and imaging protocols.
Claim 2 targets the clinically important use of identifying small suspicious lesions.

Weaknesses

The claim also contains substantial design-around opportunities:

The dose limitation can be contested through dose-tolerance and claim-construction arguments.
A provider may alter the scan start time, positioning, field of view, or scan duration.
A competitor may use a different tracer, such as prostate-specific membrane antigen PET agents.
Claim 2 depends on a specific lesion size and uptake comparison.
The claim is vulnerable to prior-art arguments based on clinical imaging protocols, FDA submissions, publications, and earlier patent families.
The presence of numerous clinical conditions creates multiple factual issues in an infringement case.

The patent is stronger against routine use of Axumin under the labeled protocol than against a substantially modified protocol or a competing tracer.

What formulation and manufacturing patents protect fluciclovine?

Patent 10,967,077 is not principally a formulation or manufacturing patent. Its claims focus on patient preparation, administration, imaging timing, scan coverage, and image interpretation.

The broader Axumin patent landscape can be divided into four categories:

Patent category	Typical subject matter	Relevance to 10,967,077
Composition patents	Fluciclovine compounds, stereoisomers, or radiolabeled amino acids	Separate from the claimed imaging protocol
Manufacturing patents	Production of [18F]-FACBC, precursor chemistry, purification, and radiolabeling	Can create supply-chain barriers
Formulation patents	Injectable solutions, stabilizers, concentration, pH, and radiopharmaceutical packaging	May apply to product manufacture or distribution
Method-of-use patents	PET imaging of recurrent prostate cancer and specified scan protocols	Closest category to Patent 10,967,077

Manufacturing protection can remain commercially important even after a method patent expires. [18F]-labeled products have short physical half-lives, requiring regional production, validated radiochemistry, transportation controls, and close coordination with imaging sites. These operational constraints can limit competition independently of patent rights.

Which companies are challenging Axumin or competing with it?

The main competitive threat is not a biosimilar. It is substitution by other prostate-cancer PET agents.

Prostate-specific membrane antigen PET

PSMA-targeted agents, including gallium-68 and fluorine-18 products, compete with Axumin for biochemical recurrence imaging. FDA-approved PSMA products include Pluvicto for therapeutic use and Locametz as a diagnostic radioligand kit, while other PSMA PET agents have received separate FDA approvals for imaging indications.[6]

PSMA PET can reduce the commercial value of an [18F]-FACBC method patent because a provider using a different active imaging agent would not practice the anti-[18F]FACBC limitation.

Generic or 505(b)(2) fluciclovine products

A competitor seeking to market fluciclovine F 18 could face:

Orange Book patent certifications.
Method-of-use patent litigation.
Drug-substance and radiochemistry manufacturing requirements.
Short shelf life and distribution challenges.
The need to demonstrate pharmaceutical equivalence or an appropriate clinical bridge.
Labeling constraints if the reference product's indication remains patent-protected.

A product with a carve-out from the patented recurrent-prostate-cancer use could reduce method-patent exposure, but the commercial value of such a product would depend on the remaining unpatented indications and market demand.

What Paragraph IV risks exist for Patent 10,967,077?

An ANDA applicant could challenge the patent through a Paragraph IV certification on several grounds:

Challenge	Potential argument
Invalidity	Lack of novelty or obviousness based on earlier fluciclovine PET protocols
Written description	The full combination of dose, fasting, exercise, positioning, timing, scan direction, and duration was not adequately disclosed
Enablement	The patent does not enable the complete scope of possible protocol variations
Indefiniteness	Terms such as "significant exercise," "suspicious location," "greater than blood pool," or "up to 30 minutes" lack sufficient boundaries
Noninfringement	The proposed label omits one or more required limitations
Inapplicability	The proposed product or indication does not use anti-[18F]FACBC for suspected prostate cancer recurrence

A Paragraph IV notice could trigger a patent action under the Hatch-Waxman framework. A successful action can produce a 30-month stay of FDA approval, subject to statutory exceptions and litigation developments.[7]

No conclusion about a current Paragraph IV challenge or settlement should be drawn without reviewing the FDA ANDA litigation database, district-court dockets, and the latest Orange Book patent certifications.

What patent litigation and settlements affect Axumin?

Patent 10,967,077 should be reviewed alongside:

Any infringement complaint filed by the NDA holder or patent owner.
Any declaratory-judgment action by a generic applicant.
Any Hatch-Waxman notice letter.
Any license or covenant not to sue.
Any settlement involving a permitted launch date.
Any stipulation concerning claim construction or validity.
Any inter partes review or post-grant proceeding.

A settlement can materially alter practical market entry even when the patent remains valid and unexpired. Typical settlement terms may include a licensed entry date, supply obligations, geographic restrictions, or a waiver of damages. The patent number alone does not establish whether such an agreement exists or remains operative.

How does Patent 10,967,077 compare with PSMA PET patent estates?

Issue	[18F]-FACBC / Axumin	PSMA PET agents
Molecular target	Amino-acid transport pathways	Prostate-specific membrane antigen
Primary use	Suspected recurrent prostate cancer	Initial staging, recurrence, and selected advanced disease uses
Patent 10,967,077 focus	Clinical administration and imaging protocol	Usually composition, ligand, radiolabeling, imaging, or therapeutic use
Biosimilar risk	Not applicable	Not applicable for small-molecule radiopharmaceuticals
Main substitution risk	PSMA PET products	Competing PSMA agents and other PET tracers
Manufacturing barrier	[18F] production, radiolabeling, distribution	Isotope supply, ligand manufacture, kits, and site logistics
Method-patent design-around	Alter protocol or use a different tracer	Use a non-claimed ligand or different indication

The competitive landscape reduces the practical value of a protocol patent when clinicians can choose an alternative tracer without using the patented molecule.

What generic launch scenarios exist for Axumin?

Three launch scenarios are commercially plausible:

Scenario 1: Patent-protected launch delay

An ANDA applicant certifies Paragraph IV, the patent owner sues, and FDA approval is delayed by litigation or a settlement date. The branded product retains the relevant indication during the dispute.

Scenario 2: Label carve-out

The applicant removes the patented recurrent-prostate-cancer use or modifies the protocol so the proposed labeling does not induce the claimed method. The commercial market may be narrower, and induced-infringement risk depends on the final label and promotional conduct.

Scenario 3: Post-expiration entry

The applicant waits until all blocking patents expire or obtains a license. This avoids an early litigation challenge but leaves the entrant exposed to manufacturing, reimbursement, radiopharmacy, and physician-adoption barriers.

A generic launch would not automatically eliminate Axumin's market. Radiopharmaceutical markets depend on local isotope production, reimbursement codes, hospital contracts, and the installed base of competing PET protocols.

What is the geographic coverage of Patent 10,967,077?

U.S. Patent 10,967,077 provides rights only in the United States. It does not directly block conduct in Europe, Canada, Japan, or other jurisdictions.

The corresponding international landscape should be reviewed through the patent family, including:

PCT applications.
European Patent Office members.
United Kingdom national rights.
Canadian and Australian counterparts.
Patent prosecution outcomes.
National expiration dates.
Divisional and continuation applications.

Foreign patents can differ materially in claim scope. A U.S. method claim may have been narrowed or canceled in another jurisdiction. National rights also have separate term-adjustment, validation, opposition, and litigation histories.

Key Takeaways

Patent 10,967,077 is a method-of-use patent for a specific anti-[18F]FACBC PET protocol.
It is closely aligned with the FDA-approved Axumin imaging workflow.
Claim 1 requires every stated clinical and imaging condition, including 370 MBq, fasting, exercise restriction, positioning, scan timing, scan range, and duration.
Claim 2 is narrower and concerns sub-centimeter suspicious lesions with uptake greater than blood pool.
The patent does not primarily protect fluciclovine composition, formulation, or radiochemical manufacturing.
It is a small-molecule diagnostic patent, so biosimilar analysis is not applicable.
PSMA PET products are the principal product-substitution threat.
Paragraph IV risk depends on Orange Book listing, the proposed generic label, claim construction, and the existence of an ANDA applicant.
The enforceable expiration date must be taken from the USPTO term calculation, including patent-term adjustment and any terminal disclaimer.
Manufacturing, isotope supply, radiopharmacy logistics, reimbursement, and competing PET agents may remain significant barriers after patent expiry.

FAQs

Does Patent 10,967,077 cover every Axumin PET scan?

No. It covers scans that satisfy all material limitations of claim 1. A scan using a different dose, timing, patient position, scan range, or preparation protocol may fall outside the literal claim.

Can a hospital infringe Patent 10,967,077 by following the Axumin label?

Potentially. If the hospital performs all claimed steps, including the specified administration and imaging conditions, it may practice the claimed method. Infringement depends on claim construction and the documented clinical procedure.

Does claim 2 require quantitative SUV measurement?

Not necessarily. The claim requires uptake greater than blood pool, but the supplied claim text does not require a specific standardized uptake value or numerical measurement. The specification and prosecution history would determine the evidentiary standard.

Can a PSMA PET product infringe Patent 10,967,077?

No, not ordinarily. The claims require anti-[18F]FACBC. A PSMA radiopharmaceutical would not satisfy that active-agent limitation.

Is Patent 10,967,077 a manufacturing patent for fluciclovine F 18?

No. The claims supplied are directed to clinical PET use. Separate patent families may address precursor compounds, radiolabeling, synthesis, purification, formulation, or distribution.

References

U.S. Food and Drug Administration. (2023). Axumin (fluciclovine F 18) injection: Prescribing information.
U.S. Food and Drug Administration. (2016, May 27). FDA approves new imaging drug to help detect recurrent prostate cancer.
U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Patent and Trademark Office. (2021). U.S. Patent No. 10,967,077, Methods of using anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid.
35 U.S.C. §§ 154, 156.
U.S. Food and Drug Administration. (2024). FDA-approved radiopharmaceuticals and prostate cancer imaging products.
21 U.S.C. § 355(j); 35 U.S.C. § 271(e).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes	10,967,077	⤷ Start Trial				POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Details for Patent: 10,967,077

Which drugs does patent 10,967,077 protect, and when does it expire?

Summary for Patent: 10,967,077