When do the PLEGISOL IN PLASTIC CONTAINER patents expire, and when will PLEGISOL IN PLASTIC CONTAINER go generic?

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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
Hospira	PLEGISOL IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium chloride	SOLUTION;PERFUSION, CARDIAC	018608-001	Feb 26, 1982	AT	RX	Yes	Yes	⤷ 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: August 21, 2026

Plegisol in Plastic Container is an established crystalloid cardioplegic solution used during open-heart surgery. Its commercial profile is driven by cardiac-surgery procedure volumes, hospital formularies, manufacturing reliability and procurement pricing rather than patent exclusivity. Pfizer’s public filings do not disclose Plegisol revenue separately, so product-level sales, margins and market share cannot be verified from public company reporting.

What is Plegisol in Plastic Container used for?

Plegisol is a sterile cardioplegic solution used to induce cardiac arrest and protect the myocardium during open-heart surgery. It is administered into the coronary circulation, generally after being mixed with blood or used according to institutional perfusion protocols. It is not intended for routine intravenous administration.

The solution contains electrolytes designed to alter myocardial membrane excitability and reduce cardiac metabolic activity during surgery. The labeled components include sodium chloride, potassium chloride, magnesium chloride and calcium chloride in water for injection, with pH adjustment as specified in the product labeling.[1]

Product profile

Attribute	Plegisol in Plastic Container
Therapeutic category	Cardioplegic solution
Primary use	Myocardial protection during cardiac surgery
Dosage form	Sterile aqueous solution
Container	Plastic container
Active pharmacology	Electrolyte-mediated cardiac arrest and myocardial protection
Administration setting	Operating room and cardiac perfusion setting
Patient population	Patients undergoing open-heart or related cardiac surgery
Regulatory category	Prescription product
Biologic status	Not a biologic
Biosimilar exposure	None
Principal commercial buyers	Hospitals, health systems and surgical distributors

The product’s value is operational. Hospitals purchase a validated, sterile solution that integrates into perfusion protocols, inventory systems and operating-room workflows.

How large is the cardioplegia-solution market?

The relevant market is the hospital cardioplegia and myocardial-protection segment, not the broader cardiovascular-drug market. Demand tracks cardiac surgical activity, including coronary artery bypass grafting, valve replacement and repair, aortic procedures, congenital-heart surgery and transplant procedures.

Market growth is constrained by several factors:

Cardiac surgery volumes in mature markets are relatively stable or structurally pressured by less-invasive interventions.
Aging populations support demand for valve surgery and complex cardiac procedures.
Increased use of transcatheter procedures diverts some patients away from open surgery.
Hospitals increasingly standardize around preferred cardioplegia protocols.
Supply continuity is critical because substitutions require pharmacy, perfusion and surgical approval.
Contract purchasing and group purchasing organizations place pressure on unit pricing.

Plegisol competes in a procurement market where product availability can matter as much as clinical differentiation. A hospital may retain a product because switching requires changes to perfusion protocols, staff training, inventory specifications and quality controls.

What are the main competitors to Plegisol?

Plegisol competes with both crystalloid and blood-based cardioplegia products. The most relevant alternatives include del Nido cardioplegia, Custodiol HTK and institutionally prepared solutions.

Product or approach	General positioning	Competitive effect on Plegisol
Plegisol	Conventional crystalloid cardioplegia	Baseline product for established protocols
del Nido cardioplegia	Often used for single-dose or extended-interval protection	Can reduce repeat dosing and perfusion workflow
Custodiol HTK	Long-duration crystalloid cardioplegia	Used in selected adult, pediatric and complex procedures
Blood cardioplegia	Blood-based myocardial protection	Strong alternative where perfusion teams prefer blood-containing protocols
St. Thomas-type solutions	Conventional crystalloid cardioplegia	Regional and institutional substitute
Compounded hospital solutions	Customized or local formulations	Potentially lower-cost but dependent on pharmacy capacity and quality systems

The principal competitive threat is protocol migration. A hospital that adopts del Nido or Custodiol HTK may reduce Plegisol purchases even if Plegisol remains clinically acceptable.

How does Plegisol compare with del Nido cardioplegia?

Plegisol is generally associated with conventional crystalloid cardioplegia protocols. Del Nido protocols are often selected when clinicians seek longer intervals between doses, simplified administration or reduced interruptions during surgery. The choice depends on procedure type, patient age, surgeon preference, perfusion practice and institutional evidence.

Neither product has a universal clinical or commercial advantage. Del Nido adoption can create a material volume risk for conventional cardioplegia products because a protocol change may affect every procedure at a hospital.

What is the FDA regulatory status of Plegisol?

Plegisol is an FDA-regulated prescription cardioplegic solution marketed for use in cardiac surgery. The product is listed in FDA and labeling databases under the cardioplegic-solution category, with Hospira and Pfizer-associated manufacturing and marketing records appearing in historical and current product documentation.[1][2]

The plastic-container presentation is commercially relevant because container integrity, sterility, extractables, leachables and storage conditions are part of the approved product configuration. A change in container system or manufacturing site can require regulatory review even when the formulation remains unchanged.

What is the Orange Book status of Plegisol?

Plegisol’s commercial protection is not meaningfully dependent on an active, enforceable composition patent. It is an older small-molecule electrolyte solution, and the relevant competitive framework is abbreviated or generic-equivalent substitution, manufacturing approval and procurement contracting.

Orange Book treatment must be evaluated by specific NDA, NDC and listing status. Public product-level materials do not establish a current blockbuster-style Orange Book patent estate for Plegisol. The product’s practical barriers are manufacturing, sterility assurance, regulatory compliance and hospital adoption rather than patent exclusivity.

What patents protect Plegisol?

No commercially significant, publicly visible patent estate is associated with the basic Plegisol electrolyte formulation or its plastic-container presentation. Any historical formulation, packaging or manufacturing patents would likely have expired given the product’s long market history.

The remaining intellectual-property issues are more likely to involve:

Manufacturing know-how.
Sterile filling processes.
Container and closure specifications.
Quality-control methods.
Supplier qualification.
Internal production procedures.
Institutional protocols and clinical publications.

These protections do not normally prevent a qualified competitor from developing and marketing a comparable cardioplegic solution.

Are there formulation patents for Plegisol?

The core formulation is an established electrolyte composition. It is unlikely to support meaningful current patent exclusivity. A competitor could pursue a different electrolyte ratio, buffering system, container configuration or dosing protocol, but those differences would create a separate product-development and regulatory pathway rather than extend Plegisol’s original exclusivity.

Are there method-of-use patents?

Plegisol’s use in myocardial protection during cardiac surgery is a mature medical application. No material current method-of-use patent position is publicly associated with the product’s principal labeled indication. Clinical protocols can still influence purchasing, but protocol preference is not equivalent to patent protection.

When did Plegisol lose exclusivity?

Plegisol is a mature product with no meaningful current new-drug exclusivity period. Any original regulatory exclusivity would have expired decades ago. The product is exposed to competition from equivalent cardioplegic solutions, alternative formulations and hospital-compounded approaches.

The relevant commercial timeline is therefore:

Period	Commercial implication
Initial launch period	Product differentiation based on approved formulation and manufacturer
Post-exclusivity period	Entry potential for comparable cardioplegic solutions
Mature-market period	Competition based on price, availability and clinical familiarity
Current market	Low patent risk; elevated supply-chain and protocol-substitution risk

No reliable public source supports a current patent expiration date that would determine Plegisol market exclusivity. The product’s market life has already moved beyond the patent-driven phase.

Which companies are challenging Plegisol?

The principal challengers are manufacturers and suppliers of competing cardioplegia products rather than named Paragraph IV litigants. Relevant competitive pressure comes from companies marketing del Nido, Custodiol HTK, blood-cardioplegia systems and other myocardial-protection products.

Because Plegisol is a mature nonbiologic solution, the relevant challenges are usually commercial or regulatory:

New abbreviated applications or equivalent product filings.
Hospital formulary conversions.
Distributor substitution.
Contract rebidding.
Compounding by hospital pharmacies.
Procedure-specific adoption of alternative cardioplegia protocols.

Are there Paragraph IV challenges or patent settlements?

No material Plegisol-related Paragraph IV litigation or patent settlement is publicly established as a current driver of the product’s market position. Paragraph IV risk is generally limited because the product lacks a commercially important active patent estate.

The absence of patent litigation does not eliminate competitive risk. A competing product can erode volume through hospital conversion, pricing or supply reliability without challenging a patent.

What litigation affects Plegisol?

No major, publicly established patent litigation appears to determine Plegisol’s current commercial trajectory. Potential legal exposure in this category is more likely to involve:

Product-liability claims.
Sterility or contamination allegations.
Manufacturing deviations.
Labeling and pharmacovigilance matters.
Supply-contract disputes.
Hospital procurement issues.

The absence of a known major case means litigation is not the primary valuation variable. Manufacturing compliance and product availability are more important.

What drives Plegisol revenue?

Plegisol revenue is principally a function of volume, price and supply continuity:

Revenue = cardiac-surgery procedures using Plegisol × units per procedure × realized net price

The major revenue drivers are:

Open-heart procedure volume. Coronary bypass, valve and aortic surgery generate the underlying demand.
Hospital protocol retention. A stable protocol supports recurring purchases.
Formulary access. Contract inclusion determines whether surgeons and perfusion teams can routinely use the product.
Supply reliability. Shortages can cause forced substitution and permanent protocol migration.
Price realization. Generic competition and group purchasing contracts limit pricing power.
Container availability. Plastic-container manufacturing capacity and packaging components can affect shipments.
Geographic penetration. Demand is concentrated in markets with established open-heart surgery infrastructure.

What is Plegisol’s financial trajectory?

Pfizer reports revenue at the segment and portfolio level and does not separately disclose Plegisol sales in its annual reports. As a result, product-specific revenue, gross margin, EBITDA contribution and forecast growth are not publicly quantifiable.[3]

The most supportable financial assessment is qualitative:

Financial variable	Expected position
Revenue scale	Small relative to Pfizer’s major medicines
Growth profile	Mature and procedure-linked
Price power	Low to moderate
Patent-driven upside	Minimal
Margin risk	Manufacturing and procurement dependent
Volume risk	Protocol substitution and open-surgery trends
Supply risk	Material because hospital alternatives may be limited during shortages
Forecast visibility	Moderate at market level, low at product level
Strategic value	Portfolio continuity and hospital account retention

Plegisol is unlikely to be a material Pfizer earnings driver. Its value is more consistent with a mature hospital product that generates recurring but comparatively modest revenue and supports a broader sterile-injectables portfolio.

What generic entry risks exist for Plegisol?

Generic entry risk is structurally high because the formulation is mature and technically straightforward relative to complex biologics or drug-device combinations. Actual entry remains dependent on sterile manufacturing capacity, FDA approval, product testing and hospital contracting.

Key entry barriers

FDA-compliant sterile manufacturing.
Validation of filling and container-closure systems.
Stability data across the approved shelf life.
Control of particulate and endotoxin levels.
Reliable sourcing of electrolyte-grade raw materials.
Distribution into cardiac surgery centers.
Hospital and group purchasing contracts.
Demonstrated supply continuity.

The most important barrier is not intellectual property. It is the ability to provide a consistently sterile, validated product at a price that supports hospital purchasing contracts.

What manufacturing and intellectual-property barriers affect Plegisol?

The plastic container creates manufacturing requirements that may limit short-term competition. A producer must qualify the container, closure and sterilization process and demonstrate that the packaging maintains product quality throughout storage and shipping.

Potential manufacturing failure points include:

Container seal integrity.
Particulate contamination.
Electrolyte concentration variability.
In-process microbial control.
Shipping-temperature excursions.
Raw-material supply interruptions.
Site-transfer validation.

These barriers can produce temporary supply advantages for an incumbent even without patent protection. They do not create durable legal exclusivity unless supported by enforceable patents or regulatory exclusivity.

What generic launch scenarios exist for Plegisol?

Base case

Plegisol remains a mature, low-growth product used in established cardiac-surgery protocols. Revenue declines gradually with procedure mix and competitive substitution, offset by recurring demand and hospital familiarity.

Downside case

A sustained manufacturing interruption or hospital shortage forces conversion to del Nido, Custodiol HTK or blood cardioplegia. Once clinicians validate the replacement protocol, Plegisol may not recover its prior volume.

Upside case

The product retains or expands hospital contracts because of reliable supply, low unit cost and clinician familiarity. Revenue increases modestly through procedure growth or share retention, but significant price expansion is unlikely.

What is the geographic coverage of Plegisol?

Plegisol’s strongest commercial relevance is in the United States, where FDA-approved hospital products, cardiac-surgery centers and group purchasing arrangements shape demand. International availability depends on country-specific registrations, distributors and local hospital procurement.

Global sales should not be inferred from the U.S. product label. Pfizer’s public reporting does not provide a country-by-country Plegisol sales breakdown or a separate international revenue series.

How strong is the Plegisol patent estate?

The patent estate is weak as a current commercial defense. Plegisol has several non-patent advantages:

Long clinical familiarity.
Established operating-room workflows.
Hospital formulary presence.
Known storage and handling requirements.
Potential distributor relationships.
Manufacturing experience.

Those advantages can support retention but do not block competitors. The product has low legal protection and moderate operational stickiness.

Key Takeaways

Plegisol in Plastic Container is a mature crystalloid cardioplegic solution used during open-heart surgery.
Its demand follows cardiac-surgery procedure volumes and hospital cardioplegia protocols.
Pfizer does not separately report Plegisol revenue, so product-level financial forecasts cannot be verified from public filings.
Patent exclusivity is not the central commercial issue; the product is long past its original exclusivity period.
The main competitors are del Nido cardioplegia, Custodiol HTK, blood cardioplegia and hospital-prepared solutions.
Generic entry is legally feasible, but sterile manufacturing, FDA compliance and hospital contracting remain practical barriers.
Supply interruptions create disproportionate risk because forced substitutions can become permanent protocol changes.
Plegisol is unlikely to be material to Pfizer’s consolidated financial results but may retain value as a recurring hospital product.

FAQs

Is Plegisol a generic drug?

Plegisol is a branded mature cardioplegic solution. It competes in a market where comparable cardioplegic solutions and alternative formulations can function as substitutes, although clinical protocols and regulatory status differ by product.

Is Plegisol administered intravenously?

No. Plegisol is used for cardiac perfusion and myocardial protection during surgery. It is not a routine intravenous medicine.

Does Plegisol have biosimilar competition?

No. Plegisol is a nonbiologic electrolyte solution and is not subject to the biosimilar pathway.

Can hospitals compound a substitute for Plegisol?

Some institutions may use pharmacy-prepared or blood-based cardioplegia protocols, subject to applicable pharmacy, quality and institutional requirements. Such substitution depends on hospital capability and clinical policy.

Is Plegisol likely to be discontinued?

Public company filings do not establish a confirmed discontinuation trajectory. Commercial continuity depends on manufacturing, demand, regulatory compliance and the company’s portfolio decisions.

References

U.S. Food and Drug Administration. (n.d.). Plegisol cardioplegic solution prescribing information. DailyMed.
National Library of Medicine. (n.d.). Plegisol: Drug labeling and product information. DailyMed.
Pfizer Inc. (2024). 2023 annual report. Pfizer Investor Relations.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	PLEGISOL IN PLASTIC CONTAINER at DailyMed

Drug Class	Blood Coagulation Factor Calculi Dissolution Agent 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

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