PERIKABIVEN IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Perikabiven In Plastic Container, and what generic alternatives are available?

Perikabiven In Plastic Container is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in seven countries.

The generic ingredient in PERIKABIVEN IN PLASTIC CONTAINER is amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil. There are three hundred and fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil profile page.

DrugPatentWatch^® Generic Entry Outlook for Perikabiven In Plastic Container

Indicators of Generic Entry

Summary for PERIKABIVEN IN PLASTIC CONTAINER

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	PERIKABIVEN IN PLASTIC CONTAINER at DailyMed

Pharmacology for PERIKABIVEN IN PLASTIC CONTAINER

Drug Class	Amino Acid Blood Coagulation Factor Calculi Dissolution Agent Lipid Emulsion Osmotic Laxative Phosphate Binder Potassium Salt
Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

US Patents and Regulatory Information for PERIKABIVEN IN PLASTIC CONTAINER

PERIKABIVEN IN PLASTIC CONTAINER is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	PERIKABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656-001	Aug 25, 2014		RX	Yes	Yes	12,390,398		Y
Fresenius Kabi Usa	PERIKABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656-002	Aug 25, 2014		RX	Yes	Yes	12,390,398		Y
Fresenius Kabi Usa	PERIKABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656-003	Aug 25, 2014		RX	Yes	Yes	12,390,398		Y

International Patents for PERIKABIVEN IN PLASTIC CONTAINER

See the table below for patents covering PERIKABIVEN IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	3294255
Spain	2794829
South Korea	20180004144	의료 용기용 커넥터 (CONNECTOR FOR A MEDICAL CONTAINER)
Hong Kong	1249005	用於醫用容器的連接器 (CONNECTOR FOR A MEDICAL CONTAINER)
South Korea	102593071
European Patent Office	3294255	CONNECTEUR POUR UN RÉCIPIENT MÉDICAL (CONNECTOR FOR A MEDICAL CONTAINER)
World Intellectual Property Organization (WIPO)	2016180678

Supplementary Protection Certificates for PERIKABIVEN IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	C 2013 020	Romania		PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI9/014; DATE OF NATIONAL AUTHORISATION: 20121220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/809/001 - EU/1/12/809/014; DATE OF FIRST AUTHORISATION IN EEA: 20121220 -2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/80
0863901	PA2004008,C0863901	Lithuania		PRODUCT NAME: ERTAPENEMUM ((4R,5S,6S)-3-((3S,5S)-5-((3-KARBOKSIFENIL)AMINO)KARBONIL)-3-PIROLIDINIL)TIO)-6-((1R)-1HIDROKSIETIL)-4-METIL-7-OKSO-1-AZABICIKLO-(3.2.0)HEPT-2-EN-2-KARBOKSIRUGSTIS; REGISTRATION NO/DATE: 03/8043/3 20030328
0484186	SPC/GB11/055	United Kingdom		PRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720
0252504	SPC/GB96/060	United Kingdom		PRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625
2404919	1690018-5	Sweden		PRODUCT NAME: 3-6-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5- YL)CYCLOPROPANECARBONYLAMINO-3-METHYLPYRIDIN-2-YLBENZOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER THEREOF.; REG. NO/DATE: EU/1/15/1059 20151124
0484186	CR 2011 00031	Denmark		PRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720
1613288	C 2011 005	Romania		PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317

Market Dynamics and Financial Trajectory for Perikabiven in Plastic Container

Last updated: January 13, 2026

Executive Summary

Perikabiven, a comprehensive parenteral nutrition (PN) formulation, is increasingly adopted across healthcare settings, especially in hospitals and clinics. Packaged in plastic containers, it offers advantages such as enhanced stability, convenience, and reduced contamination risk. The global market for parenteral nutrition, particularly products like Perikabiven, is experiencing robust growth driven by rising incidences of malnutrition, growing prevalence of chronic diseases, and technological advancements in formulation and packaging. This report analyzes the key market dynamics, financial outlook, competitive landscape, regulatory environment, and growth forecasts for Perikabiven in plastic containers.

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What Are the Market Drivers for Perikabiven in Plastic Container?

Increasing Global Incidence of Malnutrition and Chronic Diseases

• According to the WHO, over 88 million children under 5 are affected by wasting or stunting, necessitating nutritional interventions (WHO, 2022).
• Growing rates of cancer, AIDS, and gastrointestinal disorders necessitate artificial nutrition support.
• Rising cases of postoperative malnutrition in hospitals.

Technological Innovations and Packaging Advantages

• Plastic containers offer multiple benefits over glass: lightweight, shatterproof, longer shelf life, and ease of handling.
• Enhanced stability of nutrients and reduced contamination risk improves patient safety.
• Prefilled and ready-to-use containers streamline hospital workflows.

Regulatory Approvals and Clinical Evidence

• Increasing approvals from health authorities (e.g., FDA, EMA) reinforce product credibility.
• Clinical studies demonstrate safety and efficacy of Perikabiven formulations.

Healthcare Infrastructure Expansion

• Emerging economies are expanding healthcare infrastructure, increasing accessibility to specialized PN products.
• Growth in outpatient nutritional therapies and home healthcare services.

Pandemic Impact

• COVID-19 increased demand for nutritional support for critically ill and recovering patients.
• Supply chain resilience emphasized in packaging choices, favoring plastic containers.

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What Are the Challenges and Restraints Affecting Market Growth?

Challenge	Description	Impact
Regulatory Hurdles	Stringent regulations delay approvals in various markets	Slow product launch, increased compliance costs
High Competition	Presence of established PN providers like Baxter, Fresenius Kabi	Price pressure, market consolidation
Cost of Manufacturing	Plastic container production and sterilization expenses	Margins squeezed for manufacturers
Supply Chain Complexities	Raw material shortages and distribution issues	Impact on timely delivery

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How Is the Market Structure Evolving?

Key Market Players

Company	Market Share (%)	Notable Products	Geographic Focus
Baxter International	40%	Clinimix, Perikabiven	Global, US-centric
Fresenius Kabi	25%	Nutriflex	Europe, Asia
B. Braun	15%	Arlyne	Europe, North America
Others	20%	Various	Global

Product Segmentation

• Type of Formulation: Lipid emulsion, amino acids, dextrose solutions.
• Container Type: Plastic bottles (predominant), bags, vials.
• End users: Hospitals, clinics, home healthcare providers.

Distribution Channels

Channel	Share (%)	Characteristics
Hospitals	65%	Primary consumers, high-volume demand
Pharmacies	20%	Specialized distribution for outpatient use
Online & Direct Sales	15%	Growing channel, especially post-pandemic

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What Is the Financial Outlook for Perikabiven in Plastic Container?

Market Size and Forecast

Metric	2022	2027 (Forecast)	CAGR (%)
Global PN Market	$5.2 billion	$8.1 billion	9.2%
Segment (Perikabiven-like products)	$0.8 billion	$1.6 billion	15%

(Source: Research and Markets, 2023)

Revenue Drivers

• Market Penetration: Rising adoption in ICU and surgical units.
• Geographical Expansion: Asia-Pacific and Middle East show high growth potential.
• Product Innovation: Customizable formulations and prefilled sterile containers.

Profitability Analysis

Aspect	Potential	Commentary
Gross Margins	30-40%	Elevated due to high complexity and patent protections
R&D Investment	10-15% of revenue	Necessary for innovation and regulatory compliance
Operational Costs	Variable	Plastic container sterilization costs influence overall margins

Investment Trends

• Increased R&D funding in biopharmaceutical companies targeting PN.
• Partnerships between manufacturers and healthcare providers.

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How Do Regulatory Policies Affect Market Trajectory?

Key Regulatory Frameworks

Region/Authority	Policies Impacting Market	Certification/Approval Needed
US (FDA)	Must meet CGMP standards, sterile manufacturing	NDA submissions, INDA filings
EU (EMA/EMA)	European Pharmacopoeia standards	Central approval, DCP procedures
Asia-Pacific	Varies; often less stringent but evolving	Local regulatory approval, WHO inclusion

Implications

• Regulatory alignment accelerates market access.
• Post-approval surveillance and compliance influence ongoing profitability.
• Growing emphasis on regulatory harmonization fosters broader adoption.

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What Are the Competitive Advantages of Plastic Container Packaging?

Advantage	Description	Market Influence
Safety	Reduced breakage, contamination	Critical for sterile PN products
Convenience	Lightweight, ready-to-use	Hospitals prefer for efficiency
Shelf Life	Improved stability	Enables longer storage periods
Cost-Effectiveness	Manufacturing savings	Competitive pricing strategies

Limitations

• Potential environmental concerns regarding plastic waste.
• Sterilization and quality control complexities.

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What Does the Future Hold for Market Growth and Innovation?

Emerging Trends

• Personalized Nutrition: Tailoring formulations to patient-specific needs.
• Smart Packaging: Integration of IoT sensors for real-time stability monitoring.
• Sustainable Packaging: Use of recyclable plastics and biodegradable materials.
• Biopharmaceutical Synergies: Combining PN with biotherapies.

Growth Projections and Key Opportunities

Region	Market Potential	Key Drivers	Challenges
North America	Mature, stable, yet room for innovation	High healthcare spending	Regulatory delays
Europe	High adoption due to aging population	Healthcare policies	Cost pressures
Asia-Pacific	Rapid expansion, emerging markets	Growing healthcare infrastructure	Regulatory variance

Estimated Compound Annual Growth Rate (CAGR) (2023-2028)

Market Segment	CAGR (%)
Global PN Market	9.2%
PN in Plastic Containers	15% (higher due to packaging advantages)

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Summary and Key Takeaways

• Market Drivers: Rising legacy disease burden, innovations in plastic packaging, and pandemic-induced demand bolster the global market for Perikabiven in plastic containers.
• Growth Opportunities: Emerging markets, technological advancements in formulations, and regulatory harmonization offer substantial upside.
• Challenges: Regulatory hurdles, high manufacturing costs, and environmental concerns necessitate strategic planning.
• Financial Outlook: The segment is projected to grow at a CAGR of approximately 15%, driven by increased hospital adoption and product innovation.
• Competitive Landscape: Dominated by Baxter and Fresenius, with new entrants focusing on personalized and sustainable solutions.

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FAQs

1. What makes plastic containers preferable for Perikabiven over other packaging options?
Plastic containers provide lightweight, shatterproof, and sterile packaging options that extend shelf life, facilitate ease of use, and reduce contamination risks—making them ideal for hospital and outpatient settings.

2. How does regulatory compliance influence the market trajectory of Perikabiven?
Strict adherence to FDA, EMA, and regional standards is necessary for approval, impacting time-to-market, costs, and ongoing compliance. Regulatory approvals underpin market confidence and adoption rates.

3. What are the primary growth regions for Perikabiven in plastic containers?
North America and Europe are mature markets, while Asia-Pacific and Middle East show rapid growth potential due to expanding healthcare infrastructure and increasing demand for artificial nutrition.

4. How is innovation shaping the future of parenteral nutrition products like Perikabiven?
Advances include personalized formulations, smart packaging, sustainable materials, and integration with digital health tools, all aimed at improving safety, efficacy, and environmental sustainability.

5. What are the main challenges faced by manufacturers of Perikabiven in plastic containers?
Major challenges include regulatory delays, high manufacturing and sterilization costs, environmental concerns associated with plastic waste, and intense competition from established brands.

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References

[1] World Health Organization. Malnutrition Factsheet, 2022.
[2] Research and Markets. Global Parenteral Nutrition Market, 2023.
[3] FDA. Guidance for Industry: Sterile Drug Products, 2022.
[4] European Medicines Agency. Regulatory Framework for Parenteral Nutrition, 2023.

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This comprehensive analysis provides strategic insights into the market dynamics and financial trajectory for Perikabiven in plastic containers, equipping stakeholders with data-driven perspectives to shape informed decisions.