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	5,840,757

International Patents for CLINOLIPID 20%

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

Country	Patent Number	Title	Estimated Expiration
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
Portugal	88087	PROCESSO PARA A PREPARACAO DE UMA EMULSAO LIPIDICA DESTINADA A NUTRICAO PARENTERAL OU ENTERAL
Austria	65024
Netherlands	980014

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	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	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

Market Dynamics and Financial Trajectory for CLINOLIPID 20%

Last updated: July 28, 2025

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Introduction

CLINOLIPID 20% is a proprietary formulation of soybean oil-based lipid emulsion predominantly used in parenteral nutrition (PN) to manage malnutrition, especially in critical care and perioperative settings. The global parenteral nutrition market is projected to expand significantly due to rising incidences of malnutrition among hospitalized patients, increasing prevalence of chronic diseases, and advancements in infusion technology. Understanding the market dynamics and financial trajectory of CLINOLIPID 20% offers critical insights for healthcare stakeholders, pharmaceutical companies, and investors.

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Market Landscape and Key Drivers

Growing Incidence of Malnutrition and Disease Burden

Malnutrition affects approximately 45% of hospitalized patients worldwide, with higher rates in intensive care units (ICUs) and oncology settings (WHO). Undernourished patients experience longer hospital stays, increased complications, and higher mortality. CLINOLIPID 20% addresses this need by providing essential fatty acids and calories, thereby supporting recovery. The expanding patient base fuels demand for lipid emulsions like CLINOLIPID 20%.

Shift Toward Parenteral Nutrition

With the global shift to personalized medicine, parenteral nutrition is gaining acceptance over traditional nutritional approaches, especially in postoperative, oncologic, and critical care. Regulatory approvals for lipid emulsions with improved safety profiles bolster this trend, and CLINOLIPID 20% is positioned as a reliable lipid component in PN formulations.

Regulatory Environment and Approvals

Stringent regulatory regimes by FDA, EMA, and other agencies influence market entry and expansion. CLINOLIPID 20% has decades-long approval histories, with continuous updates for safety and efficacy. Such regulatory clarity encourages market adoption, especially in developed regions.

Innovation and Product Differentiation

Developments in lipid emulsions, such as structured triglycerides or alternative lipid sources, influence competitive dynamics. CLINOLIPID 20% maintains its market share through consistent quality, safety profile, and manufacturing excellence.

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Market Challenges

Pricing and Reimbursement Policies

Cost considerations significantly impact procurement decisions, especially in low- and-middle-income countries. Reimbursement policies vary, often limiting access to premium lipid emulsions like CLINOLIPID 20%.

Competition and Patent Landscape

Market entrants include other soybean oil-based emulsions (Intralipid), fish oil-based formulations (Omegaven), and newer lipid technologies. The commoditization of soybean oil emulsions pressures pricing and margins.

Supply Chain and Raw Material Variability

Dependence on soybean oil introduces vulnerability to agricultural supply disruptions, price volatility, and quality variability, influencing production costs and product availability.

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Financial Trajectory and Market Projections

Historical Performance and Revenue Streams

While specific sales figures for CLINOLIPID 20% are proprietary, the global parenteral nutrition market has exhibited steady growth. The market size was valued at approximately USD 8 billion in 2022 and expected to grow at a CAGR of 6-8% through 2030 (Grand View Research). Lipid emulsions account for a significant share, driven by clinical demands and technological evolution.

Forecasted Market Growth

The expanding prevalence of conditions requiring parenteral nutrition—such as cancer, burns, and gastrointestinal disorders—alongside increasing hospital admissions, supports a positive financial trajectory. Companies producing CLINOLIPID 20% can anticipate compounded revenues aligned with the overall PN market’s growth.

Revenue Drivers and Strategic Opportunities

• Geographic Expansion: Emerging markets, particularly Asia-Pacific and Latin America, demonstrate burgeoning healthcare infrastructure and rising malnutrition cases, representing lucrative growth zones.
• Product Line Extension: Developing adjunct formulations or enhanced safety profiles may add value.
• Partnerships and Contract Manufacturing: Collaborations with healthcare providers and OEMs can ensure steady demand and operational scalability.

Risks and Mitigation Strategies

• Market Competition: Differentiation through quality and regulatory compliance is paramount.
• Regulatory Changes: Proactive engagement with regulatory bodies ensures ongoing compliance.
• Raw Material Dependence: Diversification of sources and investment in supply chain security mitigate risks.

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Regulatory and Commercial Outlook

Continued regulatory clarity and increasing adoption in clinical protocols underpin a favorable outlook. The integration of CLINOLIPID 20% into standard PN formulations, alongside growing hospital budgets and global health initiatives, can catalyze revenue growth over the next five years.

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Conclusion

The market dynamics for CLINOLIPID 20% are driven by an increasing global disease burden necessitating parenteral nutrition, technological advancements, and evolving clinical practices. While competition and regulatory demands pose challenges, the overall financial trajectory remains optimistic due to expanding demand, geographic growth opportunities, and product stability. Strategic positioning, innovation, and supply chain resilience will be critical in capitalizing on this trajectory.

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Key Takeaways

• Growing Demand: Increasing prevalence of malnutrition and chronic illnesses fuels global demand for lipid emulsions, including CLINOLIPID 20%.
• Market Expansion: Emerging markets offer significant growth opportunities driven by expanding healthcare infrastructure.
• Competitive Landscape: Differentiation through safety, regulatory clearance, and supply chain management remains crucial.
• Financial Outlook: Expect sustained revenue growth aligned with the CAGR of the parenteral nutrition market, with potential upside from product innovation and geographic expansion.
• Risks to Monitor: Regulatory changes, raw material costs, and market competition require strategic oversight to preserve profit margins.

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FAQs

1. What role does CLINOLIPID 20% play in clinical nutrition?
   CLINOLIPID 20% serves as a lipid component in parenteral nutrition, providing essential fatty acids and calories for critically ill or malnourished patients who cannot meet nutritional needs orally or enterally.

2. Which markets offer the most growth opportunities for CLINOLIPID 20%?
   Emerging economies in Asia-Pacific, Latin America, and the Middle East present substantial growth potential due to expanding healthcare infrastructure and rising malnutrition prevalence.

3. What are the primary competitors to CLINOLIPID 20%?
   Key competitors include other soybean oil-based emulsions like Intralipid and alternative formulations such as fish-oil-based or structured triglyceride emulsions.

4. How do regulatory policies impact the sales of CLINOLIPID 20%?
   Regulatory approvals facilitate market entry and confidence, while complex approval processes or restrictions can delay adoption and impact revenues.

5. What strategic measures can companies take to maximize the financial potential of CLINOLIPID 20%?
   Companies should focus on quality assurance, broadening market access through strategic partnerships, investing in product innovation, and ensuring supply chain stability.

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References

[1] Grand View Research. (2022). Parenteral Nutrition Market Size, Share & Trends Analysis Report.
[2] World Health Organization. (2018). Malnutrition Fact Sheet.