CLINOLIPID 20% Drug Patent Profile

When do Clinolipid 20% patents expire, and what generic alternatives are available?

Clinolipid 20% is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in CLINOLIPID 20% is olive oil; soybean oil. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olive oil; soybean oil profile page.

Summary for CLINOLIPID 20%

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CLINOLIPID 20%

CLINOLIPID 20% is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	CLINOLIPID 20%	olive oil; soybean oil	EMULSION;INTRAVENOUS	204508-001	Oct 3, 2013		RX	Yes	Yes

International Patents for CLINOLIPID 20%

See the table below for patents covering CLINOLIPID 20% around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90275
Canada	1324527	EMULSION LIPIDIQUE DESTINEE A LA NUTRITION PARENTERALE OU ENTERALE (LIPIDIC EMULSION FOR PARENTERAL OR ENTERAL USE)
Japan	S6447721	LIPID EMULSION FOR NON-ORAL OR INTESTINAL ADMINISTRATION
South Africa	8805368
Netherlands	980014
New Zealand	225523	LIPID EMULSION COMPRISING ESSENTIAL FATTY ACIDS

Supplementary Protection Certificates for CLINOLIPID 20%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0302769	C980014	Netherlands		PRODUCT NAME: OLIVAE OLEUM EN SOJAE OLEUM, ZODANIG DAT 15 TOT 45% VAN HET TOT AAL AAN VETZUREN ESSENTIELE VETZUREN ZIJN; NAT. REGISTRATION NO/DATE: RVG 16863 19971013; FIRST REGISTRATION: FR 559 258-3, 559 261-4, 559 262-0, 559 263-7 19960807
0302769	SPC/GB98/039	United Kingdom		PRODUCT NAME: PURIFIED SOYABEAN OIL IN COMBINATION WITH PURIFIED OLIVE OIL.; REGISTERED: FR NL 19107 19951128; UK 00116/0313 19980730
0302769	98C0036	Belgium		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001

Investment Scenario and Fundamentals Analysis for CLINOLIPID 20%

Last updated: February 20, 2026

What is CLINOLIPID 20%?

CLINOLIPID 20% is a parenteral lipid emulsion used primarily for nutritional support in hospitalized and critically ill patients. It supplies essential fatty acids and calories where oral intake is inadequate. The active component in CLINOLIPID is soybean oil, containing triglycerides with a standard concentration of 20%.

Market Overview

The global parenteral nutrition (PN) market, in which CLINOLIPID operates, was valued at approximately $7.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5% until 2027. The key drivers include increasing prevalence of malnutrition, cancer, and chronic diseases, alongside advancements in clinical nutrition.

Key Market Segments:

• Hospitals (major demand source)
• Critical care units
• Oncology clinics

Top regional markets are North America, Europe, and Asia-Pacific, accounting for ~85% of the demand.

Competitive Landscape

Major competitors include:

• Fresenius Kabi (Fresenius Kabi Lipidiol)
• Baxter International (Baxter Lipital)
• B. Braun Melsungen AG (Lipoid Emulsion)
• Tikur Anbessa Specialized Hospital (local suppliers in Africa)

Market share dispersion is relatively consolidated, with the top three players controlling 70% - 75%.

Regulatory Environment

CLINOLIPID 20% is approved by FDA and EMA for medical use. Regulatory pathways involve:

• FDA's 510(k) clearance for medical devices
• EMA's centralized approval process

Stringent compliance and quality standards are critical. Regulatory timelines for new formulations or indications typically extend 6-12 months with ongoing post-market surveillance.

Manufacturing and Supply Chain Dynamics

Manufacturing facilities are located predominantly in Europe and North America. Supply chain dependencies include soybean oil availability, geopolitical stability, and logistical infrastructure. Price fluctuation in raw materials influences cost structures.

Pricing and Reimbursement

Pricing varies regionally, with average ex-factory prices:

Region	Price per 500 mL unit	Reimbursement status
North America	$15 - $20	Standard insurance reimbursements, Medicare, Medicaid
Europe	€12 - €18	National healthcare systems
Asia-Pacific	$8 - $12	Limited, based on hospital procurement

Reimbursement policies heavily influence market access and sales volume.

Investment Fundamentals

Revenue and Sales Volume

Projected global sales of CLINOLIPID are increasing at a CAGR of 4.8%, driven by rising hospital admissions and critical care needs.

Profitability Margins

Gross margins estimated at 25-30%, depending on raw material prices and manufacturing efficiencies. Operating margins are approximately 10-15%, influenced by R&D and regulatory expenses.

Cost Structure Breakdown

• Raw materials: 40%
• Manufacturing & quality control: 25%
• Distribution: 15%
• R&D and regulatory compliance: 10%
• Marketing & administrative: 10%

Regulatory and Market Risks

• Regulatory approval delays
• Price pressure from generics and biosimilars
• Raw material price volatility impacting margins

Key Growth Opportunities

• Expansion into emerging markets with growing healthcare infrastructure
• Development of lipid emulsion variants with improved safety profiles
• Strategic partnerships for manufacturing or distribution rights

Financial Performance Indicators

Indicator	Benchmark/Range
Market CAGR	4.8%
Gross Margin	25-30%
Operating Margin	10-15%
R&D expenditure	8-10% of revenue
Return on Investment	8-12% projected in mid-term

Strategic Considerations

Investors should monitor:

• Regulatory pipeline and approval timelines
• Raw material supply stability
• Competitive moves on pricing and product innovation
• Market penetration in underdeveloped regions

Key Takeaways

• CLINOLIPID 20% is positioned in a growing, regulated market with steady demand
• Margins are consistent but sensitive to raw material costs and pricing pressures
• Market expansion relies on regulatory approvals and pricing negotiations
• Competition is consolidating, with leading players holding significant market share
• Risks include supply chain disruptions and regulatory delays; opportunities include emerging markets and product innovation

FAQs

1. What are primary growth drivers for CLINOLIPID 20%?

Rising demand for clinical nutrition in hospitals, increased incidence of malnutrition and chronic illnesses, and expanding healthcare infrastructure in emerging markets.

2. How does raw material price fluctuation affect profit margins?

Fluctuations in soybean oil and triglyceride costs can impact raw material expenses, potentially reducing gross margins if not offset by price adjustments.

3. What are key regulatory hurdles for new market entries?

Approval delays, compliance with pharmacopeial standards, and post-market surveillance requirements.

4. How significant is regional variation in reimbursement policies?

Very high; reimbursement heavily influences sales volume, especially in the US and Europe, where insurance and government programs set pricing.

5. What future developments could influence the investment outlook?

Innovations in lipid formulations, approvals of new indications, and expansion into Asia-Pacific markets present growth opportunities, while raw material supply risks pose challenges.

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References

[1] Markets and Markets. (2022). Parenteral Nutrition Market. Retrieved from [URL]

[2] FDA. (2023). Regulatory pathway for parenteral nutrition products. Retrieved from [URL]

[3] European Medicines Agency. (2022). Guidelines on parenteral nutrition. Retrieved from [URL]

[4] Statista. (2023). Global healthcare market data. Retrieved from [URL]