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			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			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			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
China	107820421	用于医用容器的连接器 (CONNECTOR FOR A MEDICAL CONTAINER)
European Patent Office	3294255	CONNECTEUR POUR UN RÉCIPIENT MÉDICAL (CONNECTOR FOR A MEDICAL CONTAINER)
Spain	2794829
Hong Kong	1249005	用於醫用容器的連接器 (CONNECTOR FOR A MEDICAL CONTAINER)
South Korea	102593071
South Korea	20180004144	의료 용기용 커넥터 (CONNECTOR FOR A MEDICAL CONTAINER)
Poland	3294255

Supplementary Protection Certificates for PERIKABIVEN IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0925294	SPC/GB07/047	United Kingdom		PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
0925294	SZ 56/2007	Austria		PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
0812190	SPC/GB05/042	United Kingdom		PRODUCT NAME: MESYLATE, ESYLATE OR SULFATE SALTS OF N-PROPARGYL-1(R)-AMINOINDAN (RASAGILINE); REGISTERED: UK EU/1/04/304/001 20050221; UK EU/1/04/304/002 20050221; UK EU/1/04/304/003 20050221; UK EU/1/04/304/004 20050221; UK EU/1/04/304/005 20050221; UK EU/1/04/304/006 20050221; UK EU/1/04/304/007 20050221
0641330	SPC/GB04/034	United Kingdom		PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
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
0392059	0290025-6	Sweden		PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0147850	SPC/GB98/042	United Kingdom		PRODUCT NAME: 2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT AND/OR OPTIONALLY IN THE FORM OF AN ENANTIOMER, IN PARTICULAR (S)(+)-2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3; REGISTERED: UK EU/1/98/076/001 19980817; UK EU/1/98/076/002 19980817; UK EU/1/98/076/003 19980817; UK EU/1/98/076/004 19980817; UK EU/1/98/076/005 19980817; UK EU/1/98/076/006 19980817; UK EU/1/98/076/019 19980817; UK EU/1/98/076/020 19980817; UK EU/1/98/076/021 19980817; UK EU/1/98/076/013 19980817; UK EU/1/98/076/014 19980817; UK EU/1/98/076/015 19980817; UK EU/1/98/076/016 19980817; UK EU/1/98/076/017 19980817; UK EU/1/98/

Last updated: July 2, 2026

Perikabiven in Plastic Container Market Dynamics and Financial Trajectory (2026)

Perikabiven in plastic container is a parenteral nutrition (PN) product with market dynamics driven by hospital PN protocols, supply continuity for large-volume sterile liquids, and competitive pressure from alternative multichamber PN systems and amino-acid/dextrose/lipid combinations. Financial trajectory hinges on (1) continued inpatient demand for PN, (2) pricing in tender-based public procurement, (3) reimbursement and hospital formulary access, (4) competitive substitution toward newer PN and admixture formats, and (5) the ability to maintain compliant manufacturing and distribution in plastic-container form.

Because “perikabiven in plastic container” is a specific presentation, the financial picture is presentation-linked. Market performance typically tracks the number of PN-using beds, case-mix acuity, and protocol shifts in ICU, oncology, and surgical pathways. Commercial outcomes are usually measured by regional tender pricing (EU-centric in many PN lanes), hospital contracts, and channel stability rather than “launch-driven” growth.

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What is Perikabiven (plastic container) and what market does it serve?

Featured snippet answer: Perikabiven in plastic container is a parenteral nutrition product used to provide amino acids, glucose, and lipids for patients who cannot take enteral nutrition. Sales concentrate in inpatient settings where PN protocols are standardized and procurement is tender-driven.

Therapeutic role driving demand

• Indication class: PN support for adults and pediatric patients depending on the specific product authorization.
• Typical clinical users: ICU, perioperative surgery, oncology, GI disease, short bowel syndrome pathways, and patients with contraindications to enteral feeding.
• Consumption pattern: repeat hospital use tied to patient admissions and length-of-stay where PN is required.

Why the plastic container format matters commercially

Plastic PN containers can reduce handling steps versus older glass/adapter-intensive workflows and can fit standardized compounding workflows. Format continuity supports:

• Hospital procurement consolidation
• Nursing and pharmacy standardization
• Reduced risk of operational variability during admixture preparation and administration

Commercial impact is usually indirect but material. Hospitals often prefer established supply formats for workflow reliability and inventory management.

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Who are the key competitors and what pressures Perikabiven in plastic container?

Featured snippet answer: Competitive pressure comes from alternative PN emulsions and PN combination products sold as ready-to-use multicomponent systems, plus compounded PN options where local policy permits.

Competitive set by substitution logic

1. Ready-to-use multicomponent PN systems
   • Compete on convenience, standardized stability claims, and low administration friction.
2. Alternative PN emulsions and component sourcing
   • Competitors may offer different lipid composition, osmolarity ranges, or calorie-to-nitrogen ratios.
3. Compounding-based PN
   • Some systems allow hospital pharmacy compounding using component bottles. This can compete on flexibility but is challenged by staffing and contamination-control requirements.

Pricing and tender mechanics

• PN procurement is frequently tender-based, with price-per-day or price-per-bag contract economics.
• Reimbursement structures (where applicable) and hospital budget cycles drive contract renegotiation timing.
• Switching risk is lower once hospitals standardize the PN bag format, even if acquisition cost is slightly higher, because of reduced administrative burden.

Supply continuity as a differentiator

Sterile liquid supply shocks can move volume between brands quickly. If Perikabiven’s plastic container supply chain is reliable, it can win “protected volume” in hospitals that avoid disruption risk.

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When does Perikabiven face generic or biosimilar style competition risk?

Featured snippet answer: Perikabiven’s entry-risk profile is dominated by small-molecule PN composition and presentation protections rather than biosimilar frameworks. The generic threat depends on the presence and status of formulation, container, manufacturing, and use-related patents in each jurisdiction.

Patent and exclusivity categories that typically govern PN products

• Formulation patents (amino acid/dextrose/lipid ratios, stabilization systems)
• Emulsion and lipid technology patents (including lipid composition and surfactant systems)
• Container and administration system patents (plastic container-specific features, seals, connectors)
• Manufacturing/process patents (sterilization, emulsion stability controls, hold times)
• Indication or method-of-use patents (less common for PN but can occur for specific patient subsets)

Implication for financial trajectory

• If patent barriers remain, Perikabiven volume is protected by brand continuity and contract lock-in.
• When barriers expire, volume shifts can be swift in tender markets, with price pressure compressing gross margin.

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How do pricing dynamics typically evolve for PN products in plastic containers?

Featured snippet answer: PN pricing typically declines over time due to tender competition, with margin compression offset by volume and contract stickiness in institutions that prefer stable supply and standardized workflows.

Typical margin drivers

• Contract price per bag
• Logistics costs for cold-chain or stability-sensitive distribution (if applicable)
• Manufacturing cost structure tied to plastic container inputs and sterile filling yields
• Mix effects from different strength variants (e.g., calorie density and container sizes)

What changes financial performance

• New procurement cycles after hospital budget resets
• Switching events driven by supply disruptions or clinician preference changes
• Competitive undercutting once patent or regulatory barriers loosen
• Shifts in PN usage protocols (e.g., earlier transition to enteral feeds can reduce PN days and volume)

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What is the Orange Book status of Perikabiven in plastic container, and what does that imply?

Featured snippet answer: Orange Book status is jurisdiction-specific and depends on whether Perikabiven is approved as an NDC-listed product under that US review system and whether patents are listed for that specific strength and dosage form.

Perikabiven is not reliably mapped in public data without a product-specific NDC-to-Orange Book linkage. Under US practice, if patents are listed in the Orange Book for the relevant NDC, they create the legal and timing structure for generic entry (including potential Paragraph IV filings). If no patents are listed, generic competition can be more straightforward at the regulatory approval layer.

No product-specific Orange Book listing data is provided here; a precise Orange Book status statement would be presentation- and NDC-dependent.

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What litigation and settlement risks affect Perikabiven’s commercial continuity?

Featured snippet answer: For PN products, litigation risk typically centers on patent challenges to formulation, manufacturing, or container systems rather than clinical-method-of-use claims alone.

Commercial impact pathways:

• Injunction risk can delay generic substitution in tender lanes.
• Settlement agreements can establish “carve-outs” by product strength, container size, or specific markets and can preserve Perikabiven volume for a defined period.
• Protracted disputes can increase uncertainty for procurement contracting but also enable “protected volume” if entry is blocked.

No Perikabiven-specific docket or settlement terms are provided here; litigation and settlement outcomes are not asserted without docket-level confirmation.

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What regulatory events shape volume and revenue for Perikabiven in plastic containers?

Featured snippet answer: Market access and unit sales for PN products shift with regulatory renewals, manufacturing site approvals, and variations affecting stability, container compatibility, and labeling.

Key regulatory event categories:

• Variation approvals affecting container seals, closure systems, or shelf-life
• Manufacturing site changes with comparability requirements
• Label updates tied to safety communications or use instructions
• Distribution authorization and storage condition updates
• Pediatric labeling changes that can expand or restrict target patient volumes

Regulatory timing impacts financial trajectory by affecting:

• Ability to ship uninterrupted
• Hospital confidence in supply reliability
• Contract award eligibility in tender frameworks requiring compliant documentation

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What is the revenue trajectory likely to look like under three market scenarios?

Featured snippet answer: PN revenues usually follow a pattern of steady baseline demand with periodic step-changes from procurement cycles and substitution risk. Three scenarios capture typical outcomes: protected-brand steady growth, tender-driven plateau with margin compression, and step-down during generic entry.

Scenario A: Protected-brand continuity

• Drivers: strong hospital formulary presence, stable supply, limited substitution.
• Revenue pattern: stable-to-moderate growth tied to admissions, hospital expansions, and contract renewals.
• Margin: pressured but survivable; cost offsets and mix improvements matter.

Scenario B: Tender pressure without substitution breakthrough

• Drivers: competitive pricing in tenders; incremental substitution among buyers but not wholesale switching.
• Revenue pattern: volume may hold; revenue per bag declines.
• Margin: compresses; company levers include improved manufacturing yield, logistics optimization, and value-based contracting.

Scenario C: Substitution step-change after entry barriers weaken

• Drivers: loss of legal/presentation protection, regulatory approvals for equivalent PN, or aggressive price tenders.
• Revenue pattern: step-down with potential partial rebound if new contracts or mix favors remaining strengths.
• Margin: sharp compression unless the company defends with supply reliability, differentiated formulation, or contract structure.

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How does Perikabiven compare with alternative PN systems on commercialization levers?

Featured snippet answer: The strongest commercial levers in PN are supply continuity, workflow fit (bag size, connector compatibility), and tender pricing. Differentiation is often less about clinical breakthrough claims and more about operational reliability and procurement acceptance.

Comparison framework

• Contract stickiness: Hospitals standardize PN bags to reduce pharmacy and nursing variability.
• Formulation differentiation: Different caloric density and lipid composition can create clinician preference in specific patient groups.
• Operational fit: Container handling, infusion time compatibility, and compatibility with administration sets influence adoption.
• Supply reliability: Backorders and disruptions drive temporary volume migration even when prices are less favorable.

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Key takeaways

• Perikabiven in plastic container is positioned in a mature, tender-driven PN market where revenue is driven by inpatient PN days, hospital formulary adoption, and supply continuity more than by “brand hype.”
• Competitive pressure typically compresses margins first; a larger revenue step-change occurs when substitution barriers weaken and equivalent products gain tender share.
• The financial trajectory is presentation-specific and depends on contract structure, pricing resets, and regulatory/manufacturing stability.
• Litigation and patent-driven delay matter if and only if jurisdiction-specific barriers exist for the relevant NDC/strength/container system; without product-specific listing data, those effects cannot be asserted here.

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FAQs

1) What drives hospital purchasing decisions for parenteral nutrition bag brands?

Tender price, pharmacy workflow compatibility, supply reliability, and product strength availability drive adoption more than minor clinical formulation differences.

2) What happens to PN product volumes during hospital tender renewals?

Volume usually redistributes at contract award dates, with partial retention for standardized workflows and rapid switching when supply continuity improves or pricing is materially lower.

3) Do plastic-container PN products face operational adoption barriers?

Adoption barriers are usually low once hospitals standardize on a container/connector workflow; initial pharmacist and nursing training and procurement paperwork create first-cycle friction.

4) How can patent expiration affect PN revenues in tender markets?

It can trigger swift substitution in contract tenders, with price-per-bag reductions and loss of protected volume, especially for standardized strengths.

5) What regulatory factors most often delay PN shipments or sales?

Manufacturing site changes, stability/labeling variations, and distribution or storage condition updates can create shipment gaps that affect contract fulfillment and hospital confidence.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. EMA. (n.d.). European public assessment reports and variations. European Medicines Agency. https://www.ema.europa.eu/