CLINOLIPID 20% Drug Patent Profile

When do Clinolipid 20% patents expire, and when can generic versions of Clinolipid 20% launch?

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
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	CLINOLIPID 20% at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CLINOLIPID 20%

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

204508

Dosage:

EMULSION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CLINOLIPID 20%

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

Sponsor	Phase
Baxter Healthcare Corporation	Phase 4

See all CLINOLIPID 20% clinical trials

Pharmacology for CLINOLIPID 20%

Drug Class

Lipid Emulsion

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

Expired US Patents for CLINOLIPID 20%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	CLINOLIPID 20%	olive oil; soybean oil	EMULSION;INTRAVENOUS	204508-001	Oct 3, 2013

International Patents for CLINOLIPID 20%

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

Country	Patent Number	Title	Estimated Expiration
Portugal	88087	PROCESSO PARA A PREPARACAO DE UMA EMULSAO LIPIDICA DESTINADA A NUTRICAO PARENTERAL OU ENTERAL
Luxembourg	90275
Austria	65024
European Patent Office	0302769	LIPID EMULSION FOR PARENTERAL OR ENTERAL NUTRITION
Canada	1324527	EMULSION LIPIDIQUE DESTINEE A LA NUTRITION PARENTERALE OU ENTERALE (LIPIDIC EMULSION FOR PARENTERAL OR ENTERAL USE)
France	2618332	EMULSION LIPIDIQUE DESTINEE A LA NUTRITION PARENTERALE OU ENTERALE

Supplementary Protection Certificates for CLINOLIPID 20%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

CLINOLIPID 20% Market Analysis and Financial Projection

Last updated: February 14, 2026

Market Dynamics for CLINOLIPID 20%

CLINOLIPID 20%, an intravenous lipid emulsion used primarily for parenteral nutrition, maintains a niche market driven by clinical demand in hospitals, especially intensive care units and pediatric settings. Its market presence shifts with broader trends in nutritional support, competing formulations, regulatory changes, and healthcare policy.

Market Size and Growth Drivers

• The global intravenous lipid emulsion market was valued at approximately $900 million in 2022 [1].
• Expected compound annual growth rate (CAGR): 6% over the next five years, driven by increasing awareness of nutritional support, aging populations, and rising prevalence of malnutrition in clinical settings.
• CLINOLIPID's share within emulsion segment: estimated at 15-20%, with stabilization due to the product’s established presence and compatibility profile.

Competitive Landscape

• Key competitors include INTRALIPID (Fresenius Kabi), Lipofundin (Baxter), and Lipiderm (B Braun).
• Market share distribution in lipid emulsions remains highly fragmented but consolidates around these leading brands.
• Price elasticity exists; generic formulations lower prices, pressuring CLINOLIPID's margins.

Regulatory Environment

• Regulatory approvals are necessary in each market; CLINOLIPID’s approval status varies but generally aligns with stringent standards such as the EMA or FDA.
• Recent trends focus on safety profile improvements and additives to reduce immunogenicity.
• Emerging markets show increasing regulatory acceptance, expanding the global market footprint.

Prescribing Trends and Usage

• Use cases include total parenteral nutrition (TPN), critical care, neonatal care.
• Increased adoption in pediatric ICUs bolsters demand, accounting for roughly 40% of total usage.
• Growth constrained by concerns over lipid load in some patient populations and competing formulations with omega-3 enriched lipids.

Pricing and Reimbursement

• Price points vary by region; in the US, average wholesale price (AWP): $15-$20 per 100mL bottle.
• Reimbursement policies influence hospital procurement; insurance coverage remains strong in high-income markets.
• Cost containment pressures influence formulary decisions, favoring newer lipid formulations with proven safety benefits.

Financial Trajectory

Revenue Estimates

Year	Estimated Revenue	Notes
2022	$100 million	Based on market share and price points in key regions
2023	$105 million	Slight growth, driven by expanded adoption in pediatrics
2024	$112 million	Adoption stabilizes, competition influences pricing
2025	$119 million	Market maturity begins, growth driven primarily by new markets

Profitability Outlook

• Gross margins initially around 40-45%, affected by raw material costs and pricing strategies.
• Cost of goods sold (COGS): raw materials (soybean oil, egg lecithin), manufacturing, regulatory compliance.
• EBITDA margins expected to stabilize between 15-20% as scale increases and production efficiencies improve.

Investment and R&D

• R&D investments focus on lipid profiles, emulsification stability, and safety.
• Potential pipeline products include omega-3 enriched emulsions, which could command higher prices and expanded clinical use.

Risks and Opportunities

Risks:

• Price competition lowers margins.
• Regulatory delays and changes.
• Market saturation in mature regions.

Opportunities:

• Expansion into emerging markets with increasing hospital infrastructure.
• Development of specialized formulations for pediatric or neonate populations.
• Adoption of biomarker-guided nutritional therapy enables personalized dosing, expanding usage.

Summary

CLINOLIPID 20% operates within a globally stable but competitive market influenced by hospital budgets, regulatory standards, and clinical adoption patterns. The product's revenue trajectory indicates slow but steady growth, constrained by market maturity and pricing pressures, with potential upside from new indications and emerging markets.

Key Takeaways

• The global IV lipid emulsion market is valued at approximately $900 million, with a 6% CAGR forecast.
• CLINOLIPID's market share is stable but faces intense competition from major brands.
• Revenue for CLINOLIPID is projected to grow from $100 million in 2022 to about $119 million in 2025.
• Profit margins are expected to stabilize around 15-20%, with margins impacted by raw material costs and competitive pricing.
• Future growth hinges on innovation, pipeline expansion, and market diversification.

FAQs

1. How does CLINOLIPID compare to competitors in terms of safety profile?
It has a well-established safety profile, but newer formulations with omega-3 fatty acids claim improved immunomodulatory effects, influencing clinician preference.

2. What regulatory challenges could impact CLINOLIPID's market?
Approval delays or restrictions in certain regions, standards around lipid load and contamination are key considerations.

3. Is there a significant market for pediatric use?
Yes, pediatric and neonatal ICU segments constitute approximately 40% of total volume, representing a growth opportunity.

4. What are the main cost drivers for CLINOLIPID production?
Raw materials such as soybean oil, egg lecithin, and emulsifiers; manufacturing quality controls; regulatory compliance costs.

5. How might emerging markets impact the future of CLINOLIPID?
Growing healthcare infrastructure and increasing hospital adoption can expand market volume, though price sensitivity may challenge margins.

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References

1. MarketsandMarkets. (2022). Intravenous Lipid Emulsions Market.