When will the POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER patents expire, and when will generic POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	019708-001	Sep 29, 1989		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: July 13, 2026

Potassium Chloride 0.037% in Sodium Chloride 0.9% in Plastic Container: Investment Scenario and Patent/Regulatory Fundamentals

Potassium Chloride 0.037% in Sodium Chloride 0.9% in plastic container is a generic-oriented sterile IV electrolyte product with modest unit economics and high substitution risk. The investment case depends on (1) securing manufacturability and sterility/quality performance at scale, (2) winning or maintaining market access through FDA approval pathways and payer formularies, and (3) navigating a narrow but material IP barrier mix that typically favors generic entry once exclusivity and key patents lapse. The near-to-mid term market outlook is driven by hospital IV electrolyte utilization, supply reliability, and acquisition of shelf space rather than premium innovation economics.

Bottom line: treat this as an execution and compliance play with limited patent duration upside. Value creation comes from manufacturing yield, regulatory speed, supply continuity, and contracting leverage, not from durable branded moat.

What is potassium chloride 0.037% in sodium chloride 0.9% in plastic container used for?

Featured snippet answer: It is an IV admixture-like electrolyte replacement solution used to correct or prevent hypokalemia while maintaining isotonic fluid delivery, administered in hospital settings where controlled potassium supplementation is needed.

Clinical and care setting drivers

Target use: potassium supplementation with chloride counter-ion support during IV fluid therapy.
Setting: acute care hospitals, infusion centers, and perioperative protocols where clinicians titrate electrolytes.
Operational driver: nursing workflow preference for premixed ready-to-use electrolyte solutions to reduce compounding time and contamination risk.

Product differentiation that can impact demand

Container type: plastic container affects handling, compatibility, and availability.
Ready-to-use format: reduces compounding variability versus pharmacy-mixed alternatives.
Electrolyte concentration precision: supports titration protocols and standardized order sets.

What is the FDA regulatory status for potassium chloride 0.037% in sodium chloride 0.9% in plastic container?

Featured snippet answer: As a solution product in a conventional IV format, it is typically marketed as an FDA-approved drug product with an NDA and listed in the Orange Book, making generic approvals possible via ANDA once exclusivity/patents expire.

Common regulatory pathway dynamics for this category

Generics: most entrants pursue ANDA for the same route, dosage form, strength, and container.
Reference product identification: investors should assume competition clusters around the same Orange Book “listed drug” (RLD) and container configurations.
Exclusivity: the practical risk is usually patent listings (and any remaining exclusivity) rather than non-approval.

Manufacturing and CMC gating items that determine timeline risk

Sterile manufacturing controls: bioburden, endotoxin, sterility assurance.
Container-closure integrity: leachables and extractables testing relevant to plastic systems.
Assay and content uniformity: strict electrolyte concentration specifications.
Compatibility: stability and chemical compatibility with the declared container system.

What patents protect potassium chloride 0.037% in sodium chloride 0.9% in plastic container?

Featured snippet answer: For established IV electrolyte solutions, protection typically concentrates in (1) composition or concentration-specific claims, (2) container/closure or manufacturing process claims, and (3) sometimes method-of-use or stability-oriented claims. In practice, a portfolio often has limited remaining life and becomes generic-favorable over time.

Typical patent estate structure for sterile IV electrolyte generics

Composition/strength claims: potassium chloride concentration ranges tied to sodium chloride background.
Manufacturing method claims: sterile filling, mixing order, in-process controls, or specific parameter windows.
Stability and container claims: requirements to keep potency and appearance within spec through shelf life.
Use-related claims: less common than composition and manufacturing for simple electrolyte products.

Investment implication

Patent screening matters more than innovation strategy: this category is usually dominated by generic entrants once key listed patents expire.
“Listed drug” and container match drive legal exposure: a generic can be blocked or delayed if its ANDA is not “same as” the RLD in container configuration or strength mapping to a relevant patent claim.

When does potassium chloride 0.037% in sodium chloride 0.9% lose exclusivity and patent protection?

Featured snippet answer: Exclusivity and patent end dates, not clinical adoption, are the time anchors for generic entry. For IV solutions, the remaining exclusivity window is usually short or already passed for older strengths, leaving patents as the primary gating item.

How to think about the exclusivity timeline (investor lens)

First wave: formulation or composition patents expire, triggering ANDA filing readiness.
Second wave: remaining manufacturing or container-closure patents can still delay final approval or launch.
Practical launch readiness: even when approvals occur, supply chain and batch-release timing can move revenue by months.

What patent litigation affects potassium chloride 0.037% in sodium chloride 0.9% in plastic container?

Featured snippet answer: IP disputes in this category most often arise via Paragraph IV ANDA challenges targeting Orange Book-listed patents tied to the RLD.

Litigation patterns for sterile generics

Settlement-driven entry: many cases resolve through “carve-out” timing agreements and stipulations on launch dates.
Court scheduling risk: delays can result from appeal cycles and stays.
Regulatory timing interaction: an ANDA can be approved but blocked in practice pending injunction or settlement terms.

Competitive impact

Delay creates temporary pricing power: a single launch delay can matter because hospital formularies re-optimize on tender cycles.
Multiple challengers: when more than one ANDA filer exists, outcomes can diversify across competitors even with similar patent narratives.

Which companies are challenging patents with Paragraph IV for this product category?

Featured snippet answer: The challengers in sterile IV electrolyte spaces typically include mid-tier and large generic manufacturers that file ANDAs for multiple electrolyte strengths and containers, aiming to win contracted hospital distribution lanes.

Entry behavior that shapes investor expectations

Portfolio filing strategy: companies treat electrolytes as a recurring CMO/plant utilization opportunity.
Price competition: tender-driven pricing compresses margins after at least one successful generic launch.
Supply reliability as differentiator: bidders who can consistently deliver win even when price is close.

What formulations are protected, and does container matter for IP and ANDA approval?

Featured snippet answer: Container and closure configuration can matter because listed patents can be claim-linked to stability or compatibility conditions tied to a specific plastic system.

Key investor-relevant formulation/IP variables

Strength match: 0.037% potassium chloride and 0.9% sodium chloride must map to claim language and regulatory label.
Container type: plastic container integrity and leachables can be legally and regulatorily relevant.
Fill volume and overage: minor spec changes can affect both CMC and patent claim coverage in some estates.

How does potassium chloride 0.037% in sodium chloride 0.9% compare with other IV potassium and saline electrolyte solutions?

Featured snippet answer: Competitive substitutes include other premixed IV saline solutions with potassium chloride at different strengths and other isotonic/electrolyte formulations used for hypokalemia correction.

Substitution matrix for demand risk

Same-strength substitution: direct generics of the same labeled concentration and container.
Therapeutic substitution: clinicians switch to alternative potassium strengths or compounding when premixed products are unavailable.
Hospital policy substitution: formulary and order-set protocols decide whether a substitution requires pharmacy compounding.

What generic entry risks exist for potassium chloride 0.037% in sodium chloride 0.9%?

Featured snippet answer: The primary entry risk is not technical feasibility but patent/listing timing, settlement injunctions, and CMC batch-release quality. For investors, the risk is margin compression after launch rather than failure to gain approval.

Risk checklist investors should map to their scenario model

IP clock risk: unresolved listed patents or active litigation stays.
ANDA approval-to-launch gap: delays from site readiness or stability data release.
Supply continuity risk: sterile products can face stoppages due to deviations or equipment downtime.
Tender cycle risk: a launch can miss the highest-volume contract window.

What are the commercial fundamentals: pricing, demand, and margin structure?

Featured snippet answer: Demand is stable and driven by hospital electrolyte utilization. Pricing is tender-based, and margins are thin after multiple generic launches.

Revenue model drivers

Hospital purchase contracts: annualized and quarterly tender windows.
Formulary position: prefilled premixed solutions reduce compounding workload, supporting institutional adoption.
Compounding substitution: if premixed supply tightens, pharmacies may temporarily compound, reducing premixed demand but increasing it when stability improves.

Margin and cost drivers

Sterile manufacturing cost structure: compliance-driven fixed costs.
Quality-release costs: sterility testing timelines and deviations.
Logistics: container compatibility, shipping temperature needs (usually low variability for saline solutions but still material).

Investment scenario: base case, bull case, bear case

Featured snippet answer: The investment case is mostly about operational execution and competitive timing. Bull/bear outcomes hinge on launch timing versus generic saturation.

Base case (execution + limited IP drag)

One incumbent remains dominant while limited generics are in the market.
Margins normalize to generic sterile levels with steady volume.
Investment focus: manufacturing yield, consistent batch release, and contract rebids.

Bull case (delayed competition or superior supply credibility)

Entrant wins contracts early due to supply reliability.
Fewer competitors than expected slow tender price erosion.
Investment focus: capacity ramp and procurement leverage with distributors/group purchasing organizations.

Bear case (fast generic saturation and pricing compression)

Multiple generic launches converge near the same tender cycles.
Pricing compresses and volume splits across suppliers.
Investment focus shifts to cost-down and securing multi-year supply agreements.

What manufacturing and quality/IP barriers block new entrants?

Featured snippet answer: For sterile IV electrolyte solutions, the barrier is execution quality rather than novel IP. Sterility assurance, container compatibility, and batch-release consistency determine whether entrants sustain supply.

Practical barriers investors should include in diligence

Facility sterility track record: deviations correlate with lost contracts.
Container system validation: leachables/extractables and stability data acceptance.
Scalability: ability to scale without changing critical process parameters.
Regulatory inspection outcomes: warning letters or 483 observations can reset timelines.

Key licensing and partnership dynamics investors should expect

Featured snippet answer: Licensing is common when formulation know-how, container system validation packages, or regulatory dossiers are bundled with a manufacturing site.

Deal structures seen in sterile generics

Distribution agreements: market access through specialty distributors tied to hospital networks.
CMO development agreements: invest in dossier and CMC while outsourcing manufacture until capacity is stable.
Portfolio bundling: deals combine multiple electrolyte strengths to spread risk and optimize plant utilization.

Geographic considerations: where revenue risk is concentrated

Featured snippet answer: The highest risk for this US-specific investment scenario comes from US FDA approval timing, Orange Book listings, and hospital procurement tenders.

What changes by geography

Non-US: regulatory regimes differ, but sterile electrolyte commercialization still faces inspections and quality expectations.
US: Orange Book patent listings and ANDA litigation define the critical exclusivity windows.

How strong is the patent estate for this drug versus typical generic timelines?

Featured snippet answer: For simple IV electrolyte products, the patent estate strength tends to be limited by claim aging and generic predictability. The estate can still matter for delay, but durable brand-like protection is uncommon.

Investor lens: quantify estate impact as delay, not permanence

Model patent end dates as “launch inhibitors.”
Treat manufacturing readiness as a separate factor that can move launches independent of IP.

Key Takeaways

Treat potassium chloride 0.037% in sodium chloride 0.9% in plastic container as a sterile generic-style investment: execution, quality, and contract wins drive outcomes more than enduring IP.
Patent and exclusivity timing typically determines when margin compression begins.
Litigation risk is most often Paragraph IV-related and usually resolves via settlement timing or stays rather than long-term brand protection.
Container-closure and CMC acceptance are material barriers that can delay entry and affect batch-release performance.
Build scenarios around tender cycles and supply reliability, not premium pricing power.

FAQs

How do Orange Book patent listings affect ANDA launch timing for IV saline potassium chloride solutions?
Do container-closure differences between the reference product and an ANDA applicant change legal or regulatory risk for potassium chloride saline products?
What CMC data packages most commonly delay ANDA approvals for sterile electrolyte solutions in plastic containers?
How do hospital tender cycles influence revenue outcomes after a generic launch of IV electrolytes?
What manufacturing quality metrics best predict sustained supply for sterile potassium chloride saline products?

References (APA)

FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
FDA. (n.d.). ANDA (Abbreviated New Drug Application) regulatory information. U.S. Food and Drug Administration.
U.S. Code. (n.d.). 21 U.S.C. § 355(j) (Generic drug approval provisions, including patent certifications and Paragraph IV framework).

US Patents:	0
Applicants:	1
NDAs:	1

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