PERFLUBRON - Generic Drug Details

What are the generic sources for perflubron and what is the scope of patent protection?

Perflubron is the generic ingredient in one branded drug marketed by Alliance Pharm and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for PERFLUBRON

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	4
DailyMed Link:	PERFLUBRON at DailyMed

Recent Clinical Trials for PERFLUBRON

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

Sponsor	Phase
SolAeroMed Inc.	Phase 2
Auto Dealers Caring for Kids Foundation	Phase 1
ADAGP Charitable Foundation dba Auto Dealers CARing for Kids Foundation	Phase 1

See all PERFLUBRON clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PERFLUBRON

V08CX	Other magnetic resonance imaging contrast media
V08C	MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for PERFLUBRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alliance Pharm	IMAGENT	perflubron	LIQUID;ORAL	020091-001	Aug 13, 1993		DISCN	No	No

Perflubron Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 7, 2026

Perflubron, also known as perfluorooctyl bromide or PFOB, has not developed into a sustained commercial pharmaceutical market. Its principal drug-development programs involved artificial oxygen transport, liquid ventilation, and diagnostic imaging. The most commercially significant program, Alliance Pharmaceutical’s Oxygent oxygen-carrier emulsion, failed to reach approval after clinical safety concerns. Perflubron therefore has limited current revenue exposure, no established generic market, and no meaningful FDA exclusivity runway.

What is perflubron and how has it been used?

Perflubron is a highly fluorinated compound with the molecular formula C8BrF17. It can dissolve substantial quantities of oxygen and carbon dioxide and is chemically inert under conditions relevant to medical use. These properties supported several development strategies:

Development area	Product or program	Intended use	Commercial outcome
Artificial oxygen carrier	Oxygent	Temporary oxygen transport during surgery or acute blood loss	Development discontinued after clinical safety concerns
Liquid ventilation	LiquiVent and related programs	Partial liquid ventilation in respiratory disease	No durable mass-market product
Diagnostic imaging	PFOB-based formulations	Ultrasound, MRI, CT, and other imaging applications	Mostly investigational or limited development
Drug delivery and research	PFOB emulsions and particles	Oxygenation, cell tracking, and delivery systems	Niche research and specialty applications

Perflubron is distinct from perflexane, a different perfluorocarbon associated with the Imagent ultrasound contrast program. Confusing the two compounds can lead to incorrect conclusions about approvals, patents, and commercial sales.

What is the FDA regulatory status of perflubron?

Perflubron does not have a broadly marketed FDA-approved prescription-drug franchise. The FDA has evaluated perflubron-containing products through clinical-trial and investigational pathways, but no approved product has created a durable, high-volume market comparable with conventional blood products, anesthetics, respiratory drugs, or imaging agents.

The most important regulatory event was the failure of the Oxygent program. Oxygent was a perflubron-based emulsion intended to reduce or replace the need for donor blood during surgery. Clinical development encountered safety concerns, including an imbalance in neurologic events in a Phase III setting. The program was halted, and the product did not obtain FDA approval.

Perflubron’s regulatory profile is therefore defined by development failure rather than by an active approval or exclusivity period.

Does perflubron have FDA exclusivity?

No material current FDA exclusivity period is associated with perflubron as a marketed drug. The compound is not supported by an active commercial New Chemical Entity exclusivity period, pediatric exclusivity period, or significant Orange Book franchise.

Perflubron also is not a biologic. Biosimilar regulation under the Public Health Service Act is not relevant. Any future product would be regulated according to its formulation, route of administration, clinical use, and manufacturing process rather than through a biosimilar pathway.

What happened to Oxygent and its developer?

Alliance Pharmaceutical Corporation was the principal developer associated with Oxygent. The company positioned the product as an oxygen therapeutic that could reduce exposure to allogeneic blood and address blood shortages.

Oxygent’s commercial thesis depended on several assumptions:

1. Hospitals would pay a premium to reduce transfusion use.
2. Perflubron emulsions could transport oxygen safely at clinically useful doses.
3. The product could be administered around surgery without creating unacceptable neurologic, cardiovascular, or inflammatory risk.
4. Manufacturing could achieve consistent particle size, purity, stability, and oxygen-loading performance.

The clinical safety profile weakened that thesis. A blood substitute must demonstrate more than oxygen-carrying capacity. It must also avoid vasoconstriction, immune activation, coagulopathy, organ toxicity, and neurologic complications. Oxygent did not establish a regulatory profile sufficient for approval.

Alliance’s financial trajectory reflected this outcome. The company remained dependent on capital markets, licensing discussions, research collaborations, and development funding rather than recurring product revenue. The failure of Oxygent removed the company’s principal value driver and reduced the commercial value of the broader perflubron platform.

What was the financial trajectory of perflubron?

Perflubron has no separately reported, durable product-revenue stream. Financial performance was tied to development-stage funding rather than sales of an approved drug.

Development-stage economics

The commercial model generated costs in four areas:

• Toxicology and formulation work.
• Large clinical trials.
• Specialized emulsion manufacturing.
• Regulatory and quality-control infrastructure.

Those costs were incurred before any recurring product revenue. Because Oxygent did not reach approval, the program did not transition from clinical investment to commercial cash generation.

The financial trajectory can be summarized as follows:

Period	Financial condition	Market implication
Early development	Research and formulation spending	Platform value based on technical claims
Clinical expansion	Rising trial, manufacturing, and regulatory costs	Greater capital requirements and dilution risk
Phase III safety concerns	Program interruption and loss of regulatory momentum	Sharp reduction in asset value
Post-program period	Limited commercial monetization	No durable perflubron revenue base

No robust public-market valuation can be assigned to perflubron as an active marketed drug because there is no current standalone product revenue, prescription volume, or reimbursed market.

How large is the addressable market for a perflubron oxygen carrier?

The theoretical market was substantial but difficult to capture.

Potential customers included:

• Cardiac surgery centers.
• Trauma hospitals.
• Blood banks and transfusion services.
• Military medicine providers.
• Emergency-care systems.
• Countries with chronic blood shortages.

The economic value proposition was strongest where donor blood was scarce, expensive, or logistically difficult to deliver. A successful oxygen carrier could have competed with transfusion services, cell salvage, autologous donation, and restrictive-transfusion protocols.

The barriers were equally significant. Hospitals would require evidence that the product reduced transfusions without increasing mortality, stroke, renal injury, infection, or length of stay. A product used in high-risk surgery would also face intensive pharmacovigilance and procurement scrutiny.

Perflubron’s market was therefore a high-value but high-burden opportunity. It required a safety profile close to that of a conventional intravenous drug while offering a benefit measured against an established clinical intervention.

What patents protect perflubron products?

Perflubron-related intellectual property historically covered more than the molecule itself. Relevant patent categories included:

• Perfluorocarbon emulsions.
• Surfactant systems.
• Particle-size control.
• Sterilization and storage methods.
• Oxygen-loading and delivery techniques.
• Partial liquid ventilation.
• Blood-substitute uses.
• Imaging applications.
• Combination formulations with phospholipids or other excipients.

Does the compound itself retain meaningful patent protection?

The basic compound and early platform patents are old relative to modern pharmaceutical patent terms. For applications filed in the 1980s and 1990s, ordinary U.S. patent terms would generally have expired or approached expiration, subject to patent-specific filing dates, prosecution adjustments, terminal disclaimers, and regulatory extensions.

Later patents could have protected formulations or specific methods of use. Those patents would not necessarily prevent development of a chemically different perfluorocarbon emulsion or a new delivery system.

The practical IP position is therefore weaker than the technical complexity of perflubron might suggest. Manufacturing know-how, formulation stability, sterile processing, and clinical data would likely have been more important barriers than basic composition-of-matter rights.

Is perflubron listed in the Orange Book?

Perflubron does not have a significant current Orange Book listing associated with a marketed reference product. As a result:

• There is no established Orange Book patent-certification strategy.
• Paragraph IV litigation is not a current market event.
• No routine ANDA launch calendar exists.
• Generic entry is not the principal competitive threat.

If a sponsor developed a new perflubron formulation, it would likely seek protection through formulation, manufacturing, delivery, or method-of-use patents. A future approval could create a new reference product, but that would depend on an entirely new clinical and regulatory program.

Which companies are challenging perflubron?

There is no active generic or biosimilar challenge landscape comparable with major commercial drugs. The competitive pressure came from alternative technologies rather than ANDA applicants.

Relevant alternatives include:

Alternative	Competitive advantage	Limitation
Donor red blood cells	Established oxygen transport and reimbursement	Supply, storage, infection, and compatibility constraints
Cell salvage	Reduces donor-blood exposure in surgery	Limited by procedure and blood loss conditions
Hemoglobin-based oxygen carriers	Direct oxygen transport concept	Toxicity and regulatory barriers
Albumin and crystalloid solutions	Widely available volume expansion	Do not provide equivalent oxygen transport
Restrictive transfusion protocols	Reduce unnecessary blood use	Do not replace transfusion when oxygen capacity is inadequate
Synthetic or engineered carriers	Potentially scalable and standardized	Long development timelines and safety risks

Perflubron’s strongest competitors were therefore clinical practice and other oxygen-carrier platforms, not generic manufacturers.

What generic launch risks exist for perflubron?

Generic launch risk is currently low because there is no established approved reference product with significant commercial demand. The more relevant risk for a new sponsor would be non-patent competition and regulatory failure.

A new perflubron product would face five main barriers:

1. Clinical safety: neurologic, cardiovascular, renal, inflammatory, and coagulation risks.
2. Manufacturing complexity: reproducible emulsion size, sterility, oxygen capacity, and shelf life.
3. Clinical positioning: proof of benefit against transfusion, not only proof of oxygen carriage.
4. Hospital adoption: integration into surgical protocols and blood-management systems.
5. Reimbursement: a payment mechanism that recognizes reduced transfusion use or improved blood availability.

Even if legacy patents are expired, these barriers would limit rapid entry.

How strong is the perflubron patent estate?

The estate is best characterized as technically specialized but commercially weak.

IP factor	Assessment
Basic compound protection	Likely expired or commercially immaterial
Formulation patents	Potentially relevant to specific emulsions
Method-of-use patents	May protect narrow clinical applications
Manufacturing know-how	Potentially important and difficult to replicate
Orange Book leverage	Minimal in the current market
Paragraph IV exposure	Not currently material
Freedom to operate	Requires review of surviving formulation and process claims
Litigation risk	Low in the absence of an active commercial product

Patent strength would improve only if a sponsor established a new product with distinct formulation claims, clinical-use claims, or manufacturing advantages.

What licensing deals affected perflubron?

The principal commercial development model involved Alliance Pharmaceutical’s internal development and collaboration strategy. Publicly visible licensing activity did not produce a durable global product launch or a major pharmaceutical commercialization partnership.

That absence is commercially important. Large pharmaceutical companies generally require a clear approval path, differentiated clinical value, scalable manufacturing, and predictable reimbursement before committing to a global license. Oxygent’s clinical setbacks impaired each of those conditions.

There is no evidence of a current major licensing transaction supporting perflubron sales. Any contemporary valuation would therefore focus on residual patents, formulation know-how, research applications, or redevelopment potential rather than forecast prescription revenue.

What is the outlook for perflubron?

Perflubron is more likely to remain a specialty research platform than return as a broad systemic drug. Potential redevelopment could occur in narrowly defined applications where its physical properties provide a clear advantage, such as localized oxygen delivery, imaging, or specialized respiratory research.

A commercially viable redevelopment would require:

• A new clinical indication with a measurable benefit.
• A formulation that avoids the safety issues associated with earlier programs.
• A defined hospital or specialty-care customer.
• A defensible formulation or process patent position.
• A sponsor with sufficient capital for late-stage trials.

Without those conditions, perflubron has limited commercial value beyond research use and platform licensing.

Key Takeaways

• Perflubron is a perfluorocarbon drug candidate, not an established mass-market pharmaceutical.
• Its main commercial program, Oxygent, failed to reach FDA approval after clinical safety concerns.
• There is no meaningful current perflubron prescription revenue base.
• Orange Book, Paragraph IV, and biosimilar risks are not material at present.
• Legacy composition patents are unlikely to provide substantial market exclusivity.
• Formulation, manufacturing, and clinical data would be more important than basic molecule patents.
• The strongest commercial alternatives are donor blood, cell salvage, blood-management protocols, and other oxygen-carrier technologies.
• Any future value would depend on a new indication, improved safety profile, and proprietary formulation.

FAQs about perflubron market prospects

Is perflubron currently sold as an FDA-approved blood substitute?

No. Perflubron has not established a current FDA-approved blood-substitute franchise.

Is Oxygent still a commercial product?

No. Oxygent did not complete a successful path to commercialization after clinical development was halted over safety concerns.

Can a generic company launch perflubron?

There is no active generic-launch pathway tied to a widely marketed perflubron reference product. A future sponsor would likely need to develop and clinically validate a new formulation.

Is perflubron the same as perflexane?

No. Perflubron is perfluorooctyl bromide, also called PFOB. Perflexane is a different perfluorocarbon associated with separate imaging development.

Does perflubron have biosimilar competition?

No. Perflubron is a small-molecule chemical compound, not a biologic, so biosimilar regulation does not apply.

References

1. Alliance Pharmaceutical Corporation. (Various years). Annual reports and securities filings. U.S. Securities and Exchange Commission.

2. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

3. Riess, J. G. (2005). Understanding the fundamentals of perfluorocarbons and perfluorocarbon emulsions relevant to in vivo oxygen delivery. Artificial Cells, Blood Substitutes, and Biotechnology, 33(1), 47-63.

4. Spahn, D. R. (1999). Blood substitutes: Artificial oxygen carriers: Perfluorocarbon emulsions. Critical Care, 3(4), R93-R97.

5. U.S. Securities and Exchange Commission. (n.d.). EDGAR company filings. U.S. Securities and Exchange Commission.