KABIVEN IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Kabiven In Plastic Container, and when can generic versions of Kabiven In Plastic Container launch?

Kabiven 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 KABIVEN 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 Kabiven In Plastic Container

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KABIVEN IN PLASTIC CONTAINER

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	KABIVEN IN PLASTIC CONTAINER at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KABIVEN IN PLASTIC CONTAINER

Constraining patent/regulatory exclusivity:

12,390,398

NDA:

200656

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 KABIVEN IN PLASTIC CONTAINER

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

Sponsor	Phase
Fresenius Kabi	Phase 4
Wuhan TongJi Hospital	Phase 4
Beijing 301 hospital	Phase 4

See all KABIVEN IN PLASTIC CONTAINER clinical trials

Pharmacology for KABIVEN 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 KABIVEN IN PLASTIC CONTAINER

KABIVEN IN PLASTIC CONTAINER is protected by one US patents.

This potential generic entry date is based on patent 12,390,398.

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
Fresenius Kabi Usa	KABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656-004	Aug 25, 2014		RX	Yes	Yes	12,390,398		Y
Fresenius Kabi Usa	KABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656-007	Aug 25, 2014		RX	Yes	Yes	12,390,398		Y
Fresenius Kabi Usa	KABIVEN IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil	EMULSION;INTRAVENOUS	200656-005	Aug 25, 2014		RX	Yes	Yes	12,390,398		Y

International Patents for KABIVEN IN PLASTIC CONTAINER

When does loss-of-exclusivity occur for KABIVEN IN PLASTIC CONTAINER?

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

China

European Patent Office

Hong Kong

Poland

South Korea

Spain

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 KABIVEN IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20180004144	의료 용기용 커넥터 (CONNECTOR FOR A MEDICAL CONTAINER)
China	107820421	用于医用容器的连接器 (CONNECTOR FOR A MEDICAL CONTAINER)
Poland	3294255

Supplementary Protection Certificates for KABIVEN IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	300810	Netherlands		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123
0820432	07C0010	France		PRODUCT NAME: AMINOLEVULINATE DE METHYLE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 30885 20060919; FIRST REGISTRATION: SE - 16338 20010615
1870100	2012/024	Ireland		PRODUCT NAME: ETHYL 3-((2-(4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)- PHENYLAMINO)-METHY)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)- PYRIDIN-2-YL-AMINO)-PROPIONATE METHANESULPHONATE

Market Dynamics and Financial Trajectory for KABIVEN IN Plastic Container

Last updated: February 14, 2026

Overview

KABIVEN is a total nutrient admixture (TNA) used for parenteral nutrition, primarily in hospital settings. Market entry encompasses regional approvals, clinical adoption, and competitive positioning. The drug's packaging in plastic containers impacts distribution, shelf life, safety, and overall cost structure. Understanding market dynamics and financial pathways requires analyzing regulatory environments, competitive landscape, manufacturing costs, and reimbursement frameworks.

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What are the key regulatory considerations for KABIVEN in plastic containers?

KABIVEN, approved for intravenous nutrition, must comply with regulations specific to each jurisdiction. In the U.S., FDA approval depends on submission of a New Drug Application (NDA) that provides evidence of safety, efficacy, and manufacturing quality. European approval involves centralized or decentralized pathways governed by EMA, with particular standards for parenteral nutrition products.

Plastic container usage introduces additional regulatory scrutiny regarding container materials. Containers are classified as final product packaging and must meet standards such as USP <87> and <88> for extractables and leachables. ISO 13485 certification ensures manufacturing compliance for device components.

Key points:

• US and EU approvals typically take 9-12 months post-application.
• Plastic packaging must adhere to strict biocompatibility criteria.
• Changes in packaging materials post-approval necessitate supplementary filings or amendments.

What are the market drivers influencing demand for KABIVEN in plastic containers?

Demand growth stems from multiple factors:

• Rising prevalence of patients requiring parenteral nutrition: Aging populations and increased cancer treatments create chronic malnutrition cases.
• Hospital infrastructure investments: Expansion of ICU capabilities heightens use of modular, ready-to-use solutions.
• Shift toward pre-filled plastic containers: These improve safety, reduce contamination risk, and increase ease of administration.

The plastic containers improve logistical advantages over glass bottles, such as lighter weight, break resistance, and easier handling, further encouraging adoption.

How does the competitive landscape shape the market trajectory?

KABIVEN competes with other TNA formulations such as Clinimix, osmotically packaged products, and compounded solutions. Major competitors include Fresenius Kabi, B. Braun, and Hospira, which also offer plastic-packaged TNAs.

Market penetration depends on:

• Brand recognition: Established healthcare providers prefer familiar formulations.
• Cost competitiveness: Plastic containers reduce shipping and handling costs.
• Regulatory approvals and patents: Patent expirations open pathways for generic and biosimilar versions.

In markets like North America and Europe, regulation favors products with proven safety records and compliant manufacturing processes, influencing strategic positioning.

What are the manufacturing and supply chain considerations?

Manufacturing costs for KABIVEN in plastic containers involve:

• Container production: Injection molding of medical-grade plastics (e.g., PVC, polyethylene).
• Sterilization: Ethylene oxide (EO) or gamma irradiation processes.
• Quality control: Testing for particulates, microbial contamination, and leachables.

Economies of scale are critical; larger production volumes reduce per-unit costs. Supply chain disruptions, especially shortages of plastics or sterilization agents, can impact pricing and availability.

What are the revenue and profitability prospects?

Financial projections depend on:

• Market penetration rates: Initially modest, potential growth targets 10-15% annual increases in major markets.
• Pricing strategies: Premium pricing due to safety features versus competitive pressures.
• Reimbursement policies: Insurance and government reimbursement significantly influence sales volume.

Assuming the global hospital parenteral nutrition market reaches USD 4 billion by 2025, with KABIVEN capturing 8-12% based on market share and adoption rates, revenue potential estimates range from USD 320 million to USD 480 million annually.

Profitability margins are affected by manufacturing costs, which can be estimated at 20-25% of sales for sterilized plastic packaging, and distribution expenses.

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Key Takeaways

• Regulatory hurdles linked to biocompatibility and plastic container standards shape market entry.
• Demand is driven by aging populations, hospital infrastructure investments, and preference for safer, pre-filled plastic containers.
• Competitive positioning hinges on safety profile, cost advantages, and regulatory approvals.
• Manufacturing economies of scale and supply chain reliability influence profit margins.
• Growth projections for KABIVEN in plastic containers rely on adoption rates within hospital and ICU settings in key markets.

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FAQs

1. What are the main regulatory challenges for KABIVEN in plastic containers?
Meeting biocompatibility standards, obtaining approval for new packaging materials, and ensuring compliance with sterilization and leachable controls.

2. How does plastic packaging impact the cost dynamics for KABIVEN?
Plastic containers lower shipping and handling costs, reduce breakage, and improve safety, but require significant investment in sterilization and quality control.

3. Which markets offer the most growth potential for KABIVEN?
North America and Europe lead in adoption, with emerging markets in Asia-Pacific showing rapid growth driven by hospital infrastructure development.

4. How do competitors influence KABIVEN’s market share?
Established brands with extensive distribution networks and proven safety profiles pose barriers, but demand for safer, user-friendly packaging supports new entrants.

5. What impact does reimbursement policy have on revenue projections?
Reimbursement rates directly influence hospitals’ willingness to adopt KABIVEN, with favorable policies enabling higher market penetration.

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References

[1] U.S. Food and Drug Administration (FDA). (2022). Parenteral Nutrition Approval Guidelines.
[2] European Medicines Agency (EMA). (2022). Centralized Procedure for Medicinal Products.
[3] MarketsandMarkets. (2022). Parenteral Nutrition Market by Product, End User, and Region.
[4] IQVIA. (2022). Hospital Supplies Market Analysis Report.