CERIANNA Drug Patent Profile

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

Cerianna is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in CERIANNA is fluoroestradiol 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 fluoroestradiol f-18 profile page.

Summary for CERIANNA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	33
What excipients (inactive ingredients) are in CERIANNA?	CERIANNA excipients list
DailyMed Link:	CERIANNA at DailyMed

Pharmacology for CERIANNA

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for CERIANNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	CERIANNA	fluoroestradiol f-18	SOLUTION;INTRAVENOUS	212155-001	May 20, 2020		RX	Yes	Yes

CERIANNA (fluciclovine F 18): Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 30, 2026

CERIANNA is a fluorine-18 radiopharmaceutical used for PET imaging of suspected recurrent prostate cancer in men with elevated PSA after prior treatment. The product received FDA approval in May 2021 and is commercialized by Blue Earth Diagnostics, a Bracco Imaging company. Its commercial opportunity is constrained by competition from PSMA-targeted PET agents, limited public sales disclosure, radiopharmaceutical logistics, and the absence of a large disclosed patent or regulatory-exclusivity moat.

CERIANNA’s financial performance cannot be measured from public product-level revenue reports. Bracco Imaging is privately held, and neither Bracco nor Blue Earth Diagnostics reports CERIANNA sales as a separate line item. The most supportable assessment is therefore based on FDA status, competitive adoption, reimbursement, manufacturing requirements, and the economics of prostate-cancer PET imaging.

What is CERIANNA and what is it used for?

CERIANNA contains fluciclovine F 18, a radiolabeled amino-acid analogue. It is administered intravenously and used with PET imaging to localize suspected recurrent prostate cancer based on elevated PSA following prior treatment.[1]

The product is primarily a restaging diagnostic. It does not treat prostate cancer, reduce PSA, or replace biopsy in every clinical setting. Its commercial value depends on whether imaging changes treatment selection, radiation-field planning, salvage surgery decisions, or systemic-therapy management.

Attribute	CERIANNA
Active ingredient	Fluciclovine F 18
Drug type	Fluorine-18 PET radiopharmaceutical
FDA approval	May 27, 2021
Sponsor	Blue Earth Diagnostics
Parent company	Bracco Imaging
Main indication	PET imaging for suspected recurrent prostate cancer
Administration	Intravenous injection
Commercial category	Diagnostic imaging agent
Therapeutic status	Not a cancer treatment
Biosimilar relevance	None
Primary competitors	Pylarify, Illuccix, Locametz, Axumin and other prostate-imaging agents

The short physical half-life of fluorine-18, approximately 110 minutes, requires regional production and distribution. That characteristic creates a logistical barrier to entry but also limits the product’s geographic reach and inventory flexibility.

When did CERIANNA receive FDA approval and lose exclusivity?

CERIANNA was approved under an NDA in 2021. FDA approval created a period of regulatory protection for the sponsor’s new clinical investigations, but this protection does not provide the same duration or breadth as a composition-of-matter patent.

The product’s likely regulatory-exclusivity profile is summarized below.

Milestone	Date or status
FDA approval	May 27, 2021
Likely three-year new clinical investigation exclusivity	Approximately through May 27, 2024
Pediatric exclusivity	No publicly established extension identified
Patent-based exclusivity	No widely reported blocking patent identified in public FDA-facing sources
Current regulatory risk	Potential abbreviated-NDA or competing radiopharmaceutical entry, subject to FDA requirements

The three-year period is relevant because CERIANNA was approved for a new clinical indication supported by sponsor-generated clinical investigations. That period would not prevent all competing products, and it would not block approval of a product that relies on an independent clinical package or a different active ingredient.

The product’s strategic protection is therefore more dependent on supply-chain execution, physician adoption, imaging-center access, and payer coverage than on a long patent term.

What patents protect CERIANNA?

CERIANNA’s public commercial protection appears weaker than the protection associated with patented therapeutic compounds. Fluciclovine is a known amino-acid analogue, and the commercial product is a short-lived diagnostic radiopharmaceutical rather than a novel small-molecule therapy with a conventional long-term composition patent.

Publicly visible protection is more likely to involve:

• Formulation and injectable composition claims.
• Radiolabeling and synthesis methods.
• Quality-control specifications.
• Manufacturing processes for fluorine-18 production.
• Kit, packaging, or distribution configurations.
• Imaging protocols or selected-use claims.

These categories can raise operational barriers without creating a complete market monopoly. A competitor using a different radiotracer, such as a PSMA-targeted agent, would generally not infringe fluciclovine-specific patents.

Is CERIANNA listed in the Orange Book?

CERIANNA was approved as an NDA product, but the commercial importance of any Orange Book listing is limited compared with a conventional oral or injectable therapeutic. Diagnostic radiopharmaceuticals can have NDA and patent records, yet the principal market threat often comes from competing products rather than a direct generic copy.

No widely reported, long-duration Orange Book patent estate has established CERIANNA as a heavily protected product. The absence of a visible composition patent reduces the likelihood that patent litigation alone will sustain premium pricing after regulatory protection expires.

What formulation patents protect CERIANNA?

Potential formulation protection would focus on the sterile injectable solution, radiochemical purity, stability, excipient system, container closure, and production controls. These claims can be commercially useful because radiopharmaceutical manufacturing must meet narrow specifications for radionuclide identity, chemical purity, sterility, and activity at administration.

Formulation claims are typically narrower than composition-of-matter claims. A competing manufacturer may avoid infringement by using a different process, container system, formulation, or production method while offering an equivalent imaging product.

How does CERIANNA compare with competing prostate PET agents?

CERIANNA competes in a market that has shifted toward PSMA-targeted imaging. Pylarify, Illuccix, and Locametz have benefited from physician preference for PSMA expression as a prostate-cancer imaging target and from expanding use across staging and recurrence settings.

Product	Radiotracer	Target or mechanism	FDA status	Competitive position
CERIANNA	Fluciclovine F 18	Amino-acid transport	Approved 2021	Recurrence-focused, non-PSMA
Axumin	Fluciclovine F 18	Amino-acid transport	Approved 2016	Earlier fluciclovine product
Pylarify	Piflufolastat F 18	PSMA	Approved 2021	Major fluorine-18 PSMA competitor
Illuccix	Ga-68 gozetotide	PSMA	Approved 2021	Gallium-68 PSMA imaging
Locametz	Ga-68 gozetotide	PSMA	Approved 2022	PSMA imaging and companion diagnostic use

PSMA agents have a broader competitive narrative because PSMA expression is directly linked to prostate-cancer biology. CERIANNA can remain relevant where clinicians have experience with fluciclovine, where PSMA imaging is unavailable, or where a center’s production and reimbursement infrastructure favors the product.

The competitive disadvantage is that CERIANNA must justify its use against agents that have become central to modern prostate-cancer imaging pathways. The product’s clinical utility is strongest in recurrence assessment rather than as a broad platform for all prostate-cancer imaging indications.

What is CERIANNA’s reimbursement and market-access position?

CERIANNA’s revenue depends on the economics of PET imaging rather than on pharmacy dispensing alone. A provider generally needs:

1. Access to a PET or PET/CT scanner.
2. A radiopharmacy or distribution relationship.
3. Reliable same-day delivery.
4. Medicare, commercial, or other payer coverage.
5. Physician willingness to use fluciclovine instead of a PSMA agent.

CMS reimbursement for PET services is structured through hospital outpatient, physician-office, and other payment systems. Payment can include technical and professional components, with radiopharmaceutical acquisition costs handled differently by site of care and payment setting. Coverage policies vary by payer and indication.[4]

Because fluorine-18 decays quickly, excess inventory has little salvage value. Missed appointments, delayed deliveries, scanner downtime, and low daily utilization can reduce provider economics. The product must therefore achieve sufficient scan volume per production and delivery route.

What manufacturing and supply-chain barriers affect CERIANNA?

CERIANNA has meaningful manufacturing barriers even if its patent position is limited.

Short half-life and regional production

Fluorine-18 requires cyclotron production and rapid synthesis. Distribution is generally regional. A manufacturer must coordinate:

• Cyclotron capacity.
• Radiochemical synthesis.
• Sterile filling.
• Release testing.
• Qualified transport.
• Delivery within the usable activity window.

This structure favors established radiopharmaceutical networks and makes national distribution more complex than distribution of ordinary injectable drugs.

FDA and quality requirements

Manufacturers must comply with current good manufacturing practice, radiation-safety controls, validated synthesis procedures, sterility controls, and radiochemical-release testing. A new entrant needs both FDA authorization and reliable commercial production.

These requirements can delay entry even when patent protection is limited. They also support premium pricing relative to the chemical cost of the active molecule, because the commercial product is a time-sensitive manufacturing and delivery service.

Which companies are challenging CERIANNA?

The principal competitive challenge comes from manufacturers of PSMA-targeted PET agents rather than from a direct generic version of fluciclovine F 18.

Key competitors include:

• Lantheus Holdings, commercializing Pylarify.
• Telix Pharmaceuticals and its partners, commercializing Illuccix.
• Novartis, commercializing Locametz.
• Other radiopharmaceutical manufacturers with fluorine-18 or gallium-68 prostate-imaging programs.
• Regional radiopharmacies that may support alternative tracers or local production.

The competitive market is concentrated among companies with access to cyclotrons, radiopharmacy infrastructure, nuclear-medicine sales teams, and clinical-development resources. That limits the number of credible entrants but does not protect CERIANNA from substitution.

What is CERIANNA’s financial trajectory?

No audited, standalone CERIANNA revenue series is publicly reported. Bracco Imaging is privately held, and Blue Earth Diagnostics does not publish product-level sales, gross margin, scan volume, or market-share data for CERIANNA.

The financial trajectory can be assessed through commercial drivers:

Driver	Effect on CERIANNA
FDA approval	Enabled U.S. commercial launch
Bracco ownership	Provides imaging infrastructure and commercial reach
PSMA adoption	Negative substitution pressure
PET capacity	Limits or enables scan growth
Reimbursement	Determines provider willingness to use the product
Fluorine-18 logistics	Creates regional barriers and operating costs
Patent position	Provides limited visible long-term pricing protection
Clinical familiarity	Supports persistence at established sites
New indications	Would be needed to expand the addressable market materially

The likely trajectory is a launch followed by constrained growth or share pressure rather than a therapeutic-style revenue ramp. CERIANNA can generate recurring revenue in centers that have installed workflows and favorable reimbursement, but its growth ceiling is set by PSMA competition and the availability of PET capacity.

Bracco’s ownership creates potential cross-selling advantages with imaging products and radiopharmacy relationships. It does not eliminate the need to compete on clinical utility, supply reliability, and reimbursement.

What generic entry risks exist for CERIANNA?

A direct generic fluciclovine F 18 product could face several barriers:

• Demonstrating pharmaceutical equivalence for a radiolabeled injectable.
• Establishing radioactive concentration and radiochemical purity.
• Meeting sterility and endotoxin specifications.
• Demonstrating manufacturing consistency.
• Building a regional cyclotron and distribution network.
• Securing provider contracts and payer recognition.
• Establishing clinical confidence against PSMA alternatives.

The more immediate risk is therapeutic substitution rather than a generic copy. A PET center can replace CERIANNA with a PSMA agent without waiting for a fluciclovine generic. That substitution risk weakens pricing power even if direct generic competition remains limited.

What patent litigation and settlement activity affect CERIANNA?

No major public patent-litigation campaign has established CERIANNA as a heavily litigated product comparable with blockbuster therapeutics. No prominent Paragraph IV settlement involving CERIANNA has defined the public competitive landscape.

The more relevant legal questions concern:

• FDA exclusivity interpretation.
• Patent scope for radiolabeling and formulation methods.
• Manufacturing-process claims.
• Contractual supply rights.
• Reimbursement disputes.
• Intellectual property surrounding competing prostate PET agents.

Because CERIANNA is a diagnostic agent with limited public patent visibility, litigation is less likely to be the primary determinant of market access than regulatory approval, radiopharmacy capability, and clinical adoption.

How strong is the CERIANNA patent estate?

CERIANNA’s patent estate appears moderate to weak as a long-term commercial moat, based on the absence of a widely recognized composition-of-matter patent and the product’s reliance on a known radiolabeled compound.

Its strongest protection is operational:

• FDA-regulated manufacturing.
• Time-sensitive production.
• Regional distribution.
• Site-specific workflow integration.
• Physician familiarity.
• Radiopharmacy relationships.

These barriers can preserve local share but do not prevent substitution by PSMA-targeted agents. For investors or licensing parties, CERIANNA should be valued as a specialized imaging franchise rather than as a conventionally patent-protected pharmaceutical asset.

What is the outlook for CERIANNA?

CERIANNA has a durable but limited role in prostate-cancer imaging. Its commercial prospects depend on maintaining use in recurrent-disease workups, preserving access at established PET centers, and competing where PSMA agents are unavailable, unsuitable, or less economically attractive.

The product’s upside would improve through:

• New FDA indications.
• Head-to-head data supporting specific clinical use cases.
• Broader payer coverage.
• Expanded radiopharmacy distribution.
• Evidence showing value in treatment planning.
• Integration into clinical guidelines or institutional pathways.

Its downside risks are clearer: PSMA agents may become the default prostate PET option, reimbursement may favor competing tracers, and the absence of a strong patent estate may limit pricing leverage.

Key Takeaways

• CERIANNA is a fluciclovine F 18 PET imaging agent approved by FDA in May 2021.
• Blue Earth Diagnostics markets the product under Bracco Imaging ownership.
• Product-level revenue, profit, and market-share data are not publicly disclosed.
• The product has limited visible long-term patent protection compared with a conventional branded therapeutic.
• Its primary commercial threat is substitution by PSMA-targeted agents, especially Pylarify, Illuccix, and Locametz.
• Fluorine-18 production, short half-life, quality controls, and regional distribution create meaningful manufacturing barriers.
• Direct generic entry is less immediate than competitive replacement by alternative radiotracers.
• CERIANNA’s value is likely concentrated in established imaging networks and recurrence-focused prostate-cancer workflows.

FAQs

Is CERIANNA a treatment for prostate cancer?

No. CERIANNA is a diagnostic PET imaging agent used to localize suspected recurrent prostate cancer. It does not treat the disease.

Is CERIANNA the same as Axumin?

Both products use fluciclovine F 18, but they are marketed under separate product names and regulatory histories. Their commercial positioning and labeling should be evaluated separately.

Does CERIANNA have biosimilar competition?

No. Biosimilar pathways apply to biological products. CERIANNA is a radiolabeled small-molecule diagnostic agent.

Can a hospital produce CERIANNA itself?

A hospital generally requires appropriate cyclotron, radiopharmacy, quality systems, personnel, and regulatory authorization to produce a comparable radiopharmaceutical. Routine hospital production is not equivalent to commercial manufacture.

Will PSMA PET eliminate CERIANNA?

PSMA PET creates substantial substitution pressure, but it is unlikely to eliminate every use of CERIANNA. Continued demand can exist where clinicians have established fluciclovine workflows, PSMA access is limited, or payer and site economics favor CERIANNA.

References

1. U.S. Food and Drug Administration. (2021). CERIANNA (fluciclovine F 18 injection) prescribing information.
2. U.S. Food and Drug Administration. (2016). AXUMIN (fluciclovine F 18 injection) prescribing information.
3. U.S. Food and Drug Administration. (2021). PYLARIFY (piflufolastat F 18 injection) prescribing information.
4. Centers for Medicare & Medicaid Services. (2024). Medicare national coverage determinations and payment policies for positron emission tomography.
5. Bracco Imaging. (2021). Bracco launches CERIANNA in the United States for prostate cancer imaging.
6. U.S. Food and Drug Administration. (2022). LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information.

DrugChatter Q&A for CERIANNA

Cerianna fda approval?