When do the LIPOSYN III 20% patents expire, and when will LIPOSYN III 20% go generic?

Sponsor	Phase
Pennington Biomedical Research Center	Early Phase 1
The Cleveland Clinic	Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	LIPOSYN III 20%	soybean oil	INJECTABLE;INJECTION	018970-001	Sep 25, 1984		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: August 3, 2026

LIPOSYN III 20% is an intravenous soybean-oil lipid emulsion used as a calorie source and source of essential fatty acids in parenteral nutrition. Its commercial position is mature and largely commodity-based. The product has limited differentiation, no meaningful publicly disclosed product-level revenue, and faces competition from Intralipid, Nutrilipid, Clinolipid, SMOFlipid, and hospital-compounded or institutionally sourced lipid emulsions.

The principal commercial risks are product availability, hospital formulary substitution, manufacturing reliability, and procurement pricing rather than patent litigation. The core product technology is old, and the relevant composition and formulation protections are unlikely to create a material barrier to generic or alternative-source competition.

What is LIPOSYN III 20% and how is it used?

LIPOSYN III 20% is a 20% lipid injectable emulsion for intravenous administration. It is used in total parenteral nutrition and other parenteral nutrition regimens when oral or enteral nutrition is inadequate or impossible.

Product characteristic	LIPOSYN III 20%
Active lipid source	Soybean oil
Concentration	20%
Energy density	Approximately 2 kcal/mL
Route	Intravenous infusion
Primary use	Parenteral nutrition
Key excipient system	Egg phospholipids, glycerin, water for injection
Therapeutic category	Intravenous nutritional product
Main institutional customers	Hospitals, infusion centers, critical-care units, home-infusion providers
Prescription status	Prescription hospital-use product

The emulsion supplies calories and essential fatty acids. It is not a treatment for a molecular disease target, which limits opportunities for premium pricing, biomarker-based positioning, or indication expansion.

The product carries clinically important administration constraints. Risks include infection, fat overload syndrome, hypersensitivity reactions, hypertriglyceridemia, and complications associated with intravenous nutrition. The soybean-oil and egg-phospholipid components are relevant to patients with hypersensitivity to those materials. Product selection is often determined by nutrition protocols, lipid composition, triglyceride monitoring, patient age, and institutional purchasing contracts.

What is the FDA regulatory status of LIPOSYN III 20%?

LIPOSYN III is an FDA-approved lipid injectable emulsion associated with NDA 018449 in FDA public drug records. The product has historically been marketed by Hospira, which became part of Pfizer in 2015. FDA labeling identifies the product as a soybean-oil intravenous emulsion for parenteral nutrition.[1][2]

The regulatory status should be separated into three issues:

Historical FDA approval.
Current commercial availability.
Active FDA-listed marketing status for specific package configurations.

An approved NDA does not establish that every listed presentation remains commercially available. Hospital products may be discontinued, transferred, relabeled, or supplied intermittently without generating the same public commercial disclosure found for major outpatient drugs.

FDA regulatory milestones

Milestone	Regulatory significance
Original NDA approval	Established FDA approval for the lipid emulsion product
Later labeling updates	Reflected safety, dosing, administration, and manufacturing information
Hospira ownership period	Placed the product within Pfizer’s hospital-product portfolio
Current market assessment	Requires review of FDA listing, manufacturer status, and wholesaler availability by package size

LIPOSYN III should not be analyzed as a conventional branded pharmaceutical with an active promotional franchise. It is better classified as an established hospital nutritional product whose value depends on reliable supply and institutional purchasing access.

When does LIPOSYN III 20% lose exclusivity?

LIPOSYN III’s meaningful commercial exclusivity has likely expired. The product was approved decades ago, and any original composition, process, or formulation patents would generally have reached expiration long before the current market period.

For a product of this age, the principal exclusivity mechanisms are historical rather than current:

Exclusivity type	Current commercial relevance
New chemical entity exclusivity	Expired
Original formulation patents	Expected to be expired
Manufacturing patents	Any relevant early patents expected to be expired
Pediatric exclusivity	No material current effect identified
Orphan-drug exclusivity	Not applicable to the product’s nutritional use
Reference-product exclusivity	No meaningful current barrier identified
Market exclusivity from active patents	No material barrier identified in the public record reviewed

The product’s commercial protection is therefore based on manufacturing capability, regulatory compliance, purchasing relationships, and supply continuity. It is not based on a live patent moat.

What patents protect LIPOSYN III 20%?

No material active patent estate is publicly associated with LIPOSYN III 20% as a product. The underlying technology consists of a conventional intravenous lipid emulsion using soybean oil, phospholipids, glycerin, and water. These components have been used in parenteral nutrition products for many years.

Patent categories relevant to LIPOSYN III

Composition patents

Any early claims covering soybean-oil lipid emulsions or their basic component ratios would be expected to have expired. The composition is not a modern proprietary active pharmaceutical ingredient.

Formulation patents

Potential formulation claims could address:

Emulsion droplet size
Physical stability
Sterilization
Phospholipid concentration
Infusion compatibility
Container systems
Storage conditions

These features can matter operationally, but they do not appear to create a current, high-value patent barrier around LIPOSYN III itself.

Manufacturing patents

The most defensible technical know-how may involve sterile emulsification, homogenization, filtration, filling, terminal sterilization, and quality-control specifications. Manufacturing know-how can remain commercially useful after patents expire, but it is difficult to enforce against a properly approved competitor unless protected by trade secrets or a separate active patent.

Method-of-use patents

No meaningful current method-of-use patent position is associated with the routine use of LIPOSYN III for parenteral nutrition. Its use is established and broadly described in FDA labeling.

What is the Orange Book status of LIPOSYN III 20%?

LIPOSYN III does not appear to have a commercially significant Orange Book patent-listing strategy. The Orange Book is most relevant to small-molecule prescription products for which listed patents can support Paragraph IV litigation. An established intravenous nutritional emulsion typically has limited practical exposure to that framework.

The absence of an active patent strategy has several consequences:

A generic applicant would not face a meaningful patent-based launch injunction risk.
Competition is more likely to proceed through abbreviated or alternative approval pathways, depending on the product’s regulatory classification.
The principal approval risk is pharmaceutical equivalence, bioequivalence or comparative performance, sterility, container compatibility, and manufacturing validation.
Patent settlements are unlikely to be a material feature of this market.

Which companies compete with LIPOSYN III 20%?

LIPOSYN III competes in a hospital market with multiple lipid-emulsion products. The most important competitors differ in fatty-acid composition, indication emphasis, age-group labeling, institutional familiarity, and supply reliability.

Product	Company or supplier association	Lipid profile	Competitive position
Intralipid	Fresenius Kabi	Soybean oil	Long-established reference competitor
Nutrilipid	Baxter	Soybean oil	Direct hospital and parenteral-nutrition competitor
Clinolipid	Baxter	Olive oil and soybean oil	Alternative mixed-oil formulation
SMOFlipid	Fresenius Kabi	Soybean, medium-chain triglyceride, olive, and fish oils	More differentiated mixed-lipid product
LIPOSYN III	Hospira/Pfizer historical association	Soybean oil	Mature conventional lipid emulsion

Intralipid and Nutrilipid are the closest commercial substitutes because they are also soybean-oil-based products used in parenteral nutrition. Clinolipid and SMOFlipid compete through formulation differentiation rather than direct compositional identity.

How does LIPOSYN III compare with SMOFlipid?

SMOFlipid has a more diversified lipid composition that includes fish oil and medium-chain triglycerides. That formulation can support clinical differentiation in selected nutrition protocols, particularly where institutions prefer mixed-oil emulsions.

LIPOSYN III has a simpler conventional formulation. Its potential advantages are familiarity, established handling procedures, and compatibility with existing nutrition protocols. Its disadvantages are limited differentiation and greater exposure to substitution when hospitals prioritize newer lipid profiles.

How does LIPOSYN III compare with Intralipid?

The products occupy similar clinical and procurement positions because both are conventional soybean-oil emulsions. Competition is likely to be determined by:

Contract price
Available bag or bottle sizes
Wholesaler inventory
Shortage history
Institutional formulary preference
Manufacturer reliability
Labeling and operational familiarity

This competitive relationship reduces pricing power for an individual product unless it has a dependable supply advantage.

What is the market size and financial trajectory for LIPOSYN III?

Public filings do not generally disclose revenue for LIPOSYN III as a standalone product. Pfizer reports at business-segment and portfolio levels, not by individual mature hospital nutrition product. No reliable public figure establishes current LIPOSYN III sales, gross margin, or EBITDA contribution.

The financial trajectory is best characterized as mature, low-growth, and supply-sensitive.

Financial driver	Expected effect on LIPOSYN III
Unit demand	Stable to modestly declining in a mature parenteral-nutrition category
Price	Constrained by hospital contracts and competing products
Gross margin	Sensitive to soybean oil, phospholipid, energy, labor, and sterile-manufacturing costs
Sales force requirement	Low relative to specialty pharmaceuticals
Regulatory cost	Ongoing but manageable for an established product
Patent contribution	Minimal or absent
Supply-chain exposure	High
Product-line value	Portfolio and contract value rather than innovation value

The product can remain commercially relevant even with limited growth because hospitals require dependable access to intravenous nutrition. Revenue erosion can occur through product substitution, supply interruption, wholesaler delisting, or conversion to mixed-oil emulsions.

What drives revenue for mature intravenous lipid emulsions?

Revenue depends on administered volume rather than high per-patient pricing. Key demand variables include:

Number of hospitalized patients requiring parenteral nutrition
Intensive-care admissions
Surgical and gastrointestinal patient volume
Neonatal and pediatric nutrition demand
Home-parenteral-nutrition utilization
Hospital inventory policies
Shortage-driven purchasing
Relative pricing against competing lipid emulsions

Demand is less discretionary than outpatient prescription demand, but product-level loyalty is also weaker. A hospital can often substitute among approved lipid emulsions when clinical protocols and supply conditions permit.

What generic entry risks exist for LIPOSYN III 20%?

Generic entry risk is high in economic terms, although the regulatory route may not be identical to that used for a conventional oral generic tablet. The product is a sterile injectable emulsion, so approval requires more than demonstrating active-ingredient identity.

A competing applicant may need to address:

Pharmaceutical equivalence
Emulsion droplet-size distribution
Physical and chemical stability
Sterility and particulate control
Container-closure integrity
Extractables and leachables
Infusion compatibility
Manufacturing consistency
Comparative clinical or pharmacologic requirements under the applicable FDA pathway

The absence of meaningful live patents lowers litigation risk. It does not eliminate development risk. Injectable emulsions are technically demanding, and manufacturing failures can lead to recalls, shortages, or FDA warning actions.

Generic launch scenarios

Base case

The product remains available in a mature, price-competitive market. Revenue declines gradually as hospitals substitute toward competing soybean-oil or mixed-oil emulsions.

Downside case

Commercial availability becomes intermittent or ends. Customers transition to Intralipid, Nutrilipid, or another approved lipid emulsion. The value of the LIPOSYN III label and supply relationships falls sharply.

Supply-disruption case

A shortage affecting a competing product temporarily increases demand for LIPOSYN III or another substitute. This can produce short-term volume gains without creating durable pricing power.

Re-entry case

A manufacturer or licensee restores or transfers the product to serve institutional demand. Re-entry would require validated sterile manufacturing, regulatory maintenance, commercial packaging, and dependable distribution.

What patent litigation and Paragraph IV challenges affect LIPOSYN III?

No material current patent litigation or Paragraph IV settlement activity is publicly associated with LIPOSYN III 20%. The product’s commercial age and conventional formulation make patent-driven litigation less likely than regulatory and supply-chain competition.

The most relevant legal risks are operational:

FDA manufacturing compliance
Product liability
Sterility failures
Labeling disputes
Distribution and supply contracts
Hospital procurement terms
Product discontinuation and transition obligations

A Paragraph IV challenge would have limited strategic value unless a new, unexpired patent were later listed for a specific formulation, container, manufacturing process, or use. No such active patent position is central to the current LIPOSYN III market assessment.

Does LIPOSYN III have biosimilar risk?

No. Biosimilar regulation is not the relevant framework because LIPOSYN III is a non-biologic lipid emulsion rather than a therapeutic protein or other biological product.

The competitive risk is generic, follow-on, substitutable, or alternative-source competition. The closest commercial threats come from other FDA-approved lipid injectable emulsions and manufacturers with validated sterile-emulsion capacity.

What manufacturing and geographic barriers affect LIPOSYN III?

The main barrier is not geographic patent coverage. It is the ability to manufacture and distribute a sterile injectable emulsion consistently across regulated markets.

Manufacturing barriers

Specialized high-shear mixing and homogenization
Control of emulsion particle size
Aseptic processing or validated sterilization
Low particulate burden
Stability through shelf life
Reliable soybean-oil and phospholipid sourcing
Container and closure compatibility
Cold-chain or controlled-storage logistics where required
FDA inspection readiness

Geographic coverage

LIPOSYN III’s commercial position is primarily tied to the U.S. hospital market and the regulatory status of specific presentations. Approval in one jurisdiction does not automatically establish market access elsewhere. International markets may use different lipid emulsions, labeling, nutrition guidelines, and procurement systems.

The absence of a strong active patent estate means geographic expansion would depend mainly on regulatory registration, local manufacturing or import compliance, distribution agreements, and reimbursement or hospital purchasing access.

How strong is the LIPOSYN III patent estate?

The patent estate is weak as a current commercial defense.

Patent-estate factor	Assessment
Core composition protection	Expired or commercially immaterial
Active formulation patents	No material public position identified
Method-of-use protection	Minimal
Manufacturing patents	Possible historical relevance, limited current exclusionary value
Orange Book leverage	Limited
Paragraph IV exposure	Low strategic importance
Trade-secret value	Potentially relevant to process execution
Overall patent strength	Low

The product’s value is therefore operational rather than patent-based. A buyer or licensee would assess manufacturing economics, regulatory maintenance, customer contracts, shortage exposure, and portfolio fit more heavily than patent term.

Are there licensing deals for LIPOSYN III?

No major current licensing transaction centered specifically on LIPOSYN III 20% is publicly established in the principal public sources reviewed. The product’s ownership history is more relevant than a current licensing premium. Hospira’s acquisition by Pfizer consolidated the historical Hospira hospital-product portfolio within Pfizer.[3]

Any private supply, distribution, contract-manufacturing, or regional commercialization arrangement would not necessarily be disclosed publicly. Such arrangements would matter commercially if they controlled the product’s NDA, manufacturing site, distribution rights, or hospital contracts.

Key Takeaways

LIPOSYN III 20% is a mature soybean-oil intravenous lipid emulsion used in parenteral nutrition.
Its core composition and use are longstanding and do not support a meaningful current patent moat.
No material active Orange Book, Paragraph IV, or patent-litigation strategy is associated with the product.
The principal competitors are Intralipid, Nutrilipid, Clinolipid, and SMOFlipid.
Revenue is not publicly disclosed at the product level.
The financial profile is likely mature, low-growth, and sensitive to hospital pricing, supply continuity, and substitution.
Generic and alternative-source competition is economically significant, while biosimilar risk is not applicable.
Manufacturing validation, sterility, emulsion stability, and distribution reliability are the main barriers to entry.
Commercial value depends more on regulatory status, supply availability, and institutional contracts than on exclusivity.

FAQs About LIPOSYN III 20%

Is LIPOSYN III 20% still commercially available?

Availability can vary by package configuration, manufacturer status, wholesaler inventory, and hospital distribution channel. Historical FDA approval does not establish continuous commercial supply.

Is LIPOSYN III the same as Intralipid?

Both are conventional soybean-oil lipid emulsions used in parenteral nutrition, but they are separate products with different labeling, manufacturers, presentations, and commercial supply arrangements.

Can hospitals substitute SMOFlipid for LIPOSYN III?

Substitution depends on the patient population, institutional nutrition protocol, clinician judgment, product labeling, and available supply. SMOFlipid has a different mixed-lipid composition and should not be treated as compositionally identical.

Does LIPOSYN III require a patent license for generic manufacture?

No material current product patent license requirement is publicly associated with LIPOSYN III. A manufacturer would still need the applicable FDA approval, validated sterile manufacturing, and compliant distribution.

What is the main investment risk associated with LIPOSYN III?

The main risk is loss of commercial relevance through discontinuation, supply instability, hospital substitution, or price erosion. Patent expiration is not the principal risk because the product’s meaningful exclusivity is already historical.

References

U.S. Food and Drug Administration. (n.d.). LIPOSYN III 20%: Soybean oil injection, emulsion prescribing information. FDA labeling records.
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: LIPOSYN III, NDA 018449. https://www.accessdata.fda.gov/scripts/cder/daf/
Pfizer Inc. (2015). Pfizer completes acquisition of Hospira. Pfizer investor and corporate materials.
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research.
DailyMed. (n.d.). Lipid injectable emulsion product labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	4
DailyMed Link:	LIPOSYN III 20% at DailyMed

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