LIPOSYN III 30% Drug Patent Profile

Which patents cover Liposyn Iii 30%, and when can generic versions of Liposyn Iii 30% launch?

Liposyn Iii 30% is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in LIPOSYN III 30% is soybean oil. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the soybean oil profile page.

Summary for LIPOSYN III 30%

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIPOSYN III 30%
DailyMed Link:	LIPOSYN III 30% at DailyMed

Recent Clinical Trials for LIPOSYN III 30%

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

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

See all LIPOSYN III 30% clinical trials

US Patents and Regulatory Information for LIPOSYN III 30%

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 30%	soybean oil	INJECTABLE;INJECTION	020181-001	Jan 13, 1998		DISCN	No	No

International Patents for LIPOSYN III 30%

When does loss-of-exclusivity occur for LIPOSYN III 30%?

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

Argentina

Australia

Brazil

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

Poland

Russian Federation

South Korea

Spain

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 LIPOSYN III 30% around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	090632	PORTADOR DE CARTUCHO E INYECTOR DEL TIPO DE BOLIGRAFO
Australia	2013247058	Cartridge holder and pen-type injector
Brazil	112014025232	suporte de cartucho

Last updated: June 26, 2026

Liposyn III 30% market dynamics and financial trajectory: pricing, demand drivers, competition, and exclusivity

Executive summary: Liposyn III 30% (an IV fat emulsion used in parenteral nutrition) is a niche hospital-only product with demand driven by total parenteral nutrition (TPN) utilization, neonatal and critical-care prescribing, and formulary access. Financial trajectory is typically constrained by (1) limited population size, (2) clinician preference for specific lipid platforms and omega-3/omega-6 composition, (3) hospital pharmacy contracting dynamics, and (4) inventory and supply-chain stability for sterile injectables. Detailed, drug-specific financials (US net sales, unit volumes, segment revenue impact), exclusivity/Orange Book status, and patent expiration dates cannot be produced from the provided information.

What can be stated from drug-class mechanics (TPN lipid emulsion market):

• Demand is inelastic within clinical protocols. When patients require TPN, lipid emulsions are part of standardized nutrition regimens, but hospitals rotate among lipid products based on cost, availability, and lipid composition.
• Pricing is contract-driven, not list-driven. Net price is typically determined through hospital group purchasing organizations, pharmacy benefit-like contracting for institutions, and narrow tender processes.
• Competition is typically by formulation and national account access. Substitutes often include other lipid emulsions (e.g., soybean oil-based, MCT/LCT mixes, olive oil/omega-3-based, and newer structured emulsions), not “therapeutic class” competition in the broad consumer sense.
• Supply continuity affects outcomes. For injectable sterile nutrition products, shortages can shift demand temporarily and create short-term revenue variability for the available suppliers.

What drives Liposyn III 30% demand in the hospital parenteral nutrition market?

Featured snippet answer: Demand for Liposyn III 30% is driven by hospital and NICU/ICU utilization of TPN, clinical need for IV lipid calories, and formulary inclusion tied to cost, compatibility, and supply reliability.

Which patient segments use 30% lipid emulsion most?

• Neonates and pediatrics (including NICU). Lipid emulsions are used to meet essential fatty acid requirements and calorie goals when enteral nutrition is insufficient.
• Critical care and surgical patients. TPN is used during perioperative periods, severe malabsorption, or contraindications to enteral feeding.
• Long-stay and malnutrition risk populations. Oncology, short-bowel syndrome, and chronic GI dysfunction can extend TPN duration.

What clinical protocol factors influence use of a specific lipid brand?

• Essential fatty acid adequacy and dosing schedules.
• Tolerance and safety outcomes observed with the institution’s lipid platform.
• Compatibility and administration workflow in pharmacy and nursing practice.
• Availability during shortages, which can reallocate volume even without preference shifts.

How do pricing and contracting mechanics shape Liposyn III 30% financial performance?

Featured snippet answer: Net revenue is dominated by institutional contracting terms, tender timing, and discounting, so financial trajectory tracks hospital budget cycles and group purchasing outcomes.

What determines net price for sterile IV injectables?

• National account and GPO contracts that set tiered pricing by volume.
• Tender bids and re-bids every 6 to 36 months.
• Shortage allocations that can increase short-term revenue but also reduce predictability.
• Freight and distribution terms for wholesalers and hospital pharmacies.

What does “market share” mean in this category?

• Share is measured by units infused per eligible patient, not prescriptions in the outpatient sense.
• A hospital can switch lipid products based on product evaluations, adverse event trends, or supply disruptions.

What competitive forces threaten Liposyn III 30% revenue growth?

Featured snippet answer: Competitive pressure comes from alternative lipid emulsion platforms (cost, lipid composition, and safety perception) and from formulary switching driven by hospital procurement.

What are the main substitution pathways?

• Therapeutic substitution among lipid emulsions used for TPN calories and essential fatty acid needs.
• Formulary substitution based on total nutrition regimen outcomes and budget constraints.
• Clinical switching during shortages when preferred products are unavailable.

How does supply-chain stability affect competitiveness?

• Hospitals prioritize continuity of supply to avoid disruption in TPN schedules.
• A supplier with stable availability can take share even if its price is not the lowest.

When does Liposyn III 30% face generic or biosimilar-like pressure?

Featured snippet answer: Generic pressure depends on whether Liposyn III 30% has a protected formulation or exclusivity status and on whether equivalent products are approved and market-ready. Without Orange Book/exclusivity and patent estate details, a launch timeline cannot be stated.

What signals a category is ready for wider substitution?

• Multiple approved lipid emulsion options with comparable indications and dosing.
• Established procurement preferences that favor cost.
• Regulatory approvals for additional manufacturers that expand supply.

What does the Liposyn III 30% revenue trajectory likely look like by period?

Featured snippet answer: The trajectory is typically lumpy around contract renewals, product availability, and institutional switching cycles rather than showing smooth growth like chronic outpatient drugs.

Typical revenue shape in hospital nutrition injectables

• Pre-contract and re-bid periods: negotiating leverage increases; revenue can flatten.
• Post-contract ramp: volume increases if switching is completed and staff retraining is done.
• Supply events: winners capture temporary demand; losses occur if inventory is constrained.

How does Liposyn III 30% compare with alternative parenteral lipid emulsions on economics?

Featured snippet answer: Cost-per-gram of lipid and total TPN regimen cost drive economics; clinical protocols influence whether switching is acceptable.

What decision levers hospitals use in lipid selection?

• Acquisition cost per unit and per delivered lipid dose.
• Storage and handling complexity in pharmacy.
• Administration workflow (e.g., compatibility with TPN admixtures and line management).
• Clinical preference based on lipid composition and local outcome experience.

What regulatory status affects Liposyn III 30% market access and competition?

Featured snippet answer: Regulatory listing in FDA systems (Orange Book for approved drug products with patents, and labeling/approval history) governs eligibility for legal challenges and new entrants. Drug-specific status cannot be enumerated without listing data.

Key regulatory artifacts that matter for market dynamics

• FDA approval pathway and labeling scope.
• Whether patents are listed in the Orange Book for the exact product/strength.
• Pediatric and exclusivity-related provisions that extend market protection.

What patents protect Liposyn III 30% and how strong is the estate?

Featured snippet answer: Patent estate strength determines how quickly non-authorized competitors can enter; strength cannot be assessed without patent identifiers, assignees, and expiration dates for the exact product/strength.

What patent types commonly show up in this category?

• Formulation patents covering lipid composition and ratios.
• Manufacturing method patents for emulsification, particle size control, stability, and sterilization.
• Method-of-use patents are less common for nutrition lipids but can occur depending on specific clinical claims.

What does Liposyn III 30% litigation activity imply for future market entry?

Featured snippet answer: Patent litigation and settlement terms shape launch timing and can force delayed competition or authorized supply arrangements. Drug-specific litigation cannot be mapped without docket-level inputs.

What to look for in litigation that affects revenue

• Paragraph IV filings and any associated stay/180-day exclusivity mechanics.
• Settlement agreements that define permitted launch dates and design-around constraints.

How many hospitals can actually buy Liposyn III 30%, and what does that mean for scale?

Featured snippet answer: Scale is determined by formulary coverage in hospital systems and by whether wholesalers carry sufficient stock at scale.

Distribution constraints that limit addressable market

• Wholesaler inventory practices for high-turn sterile injectables.
• Hospital formulary exclusions that require exception processes.
• Contract tiering that limits purchases to approved SKUs.

Key Takeaways

• Liposyn III 30% is a hospital TPN lipid emulsion where demand is tied to TPN intensity in NICU/ICU and other inpatient settings.
• Financial trajectory is typically contract- and supply-cycle-driven, with volume changes around re-bids and availability events.
• Competitive pressure comes mainly from other IV lipid emulsion platforms that can win formulary status via total cost and protocol fit.
• Determining generic/entry timelines, patent strength, and Orange Book status requires product-specific FDA listing and patent identifiers, which are not provided here.

FAQs

1. What is Liposyn III 30% used for in hospitals?
2. How do group purchasing organizations influence net pricing for TPN lipid emulsions?
3. What factors cause hospitals to switch from one IV lipid emulsion to another?
4. How do supply shortages impact revenue and market share for sterile injectable nutrition products?
5. What patent and Orange Book mechanisms determine when generic-equivalent lipid emulsions can enter?

References

1. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA. Drugs@FDA database. (Accessed via Drugs@FDA database).
3. FDA. Guidance for Industry: Patent Listing Requirements and Relevant Regulatory Provisions. (Relevant FDA guidance documents).