List of Excipients in Branded Drug MULTRYS

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
American Regent Inc	MULTRYS	trace elements injection 4	0517-9302	WATER	2041-07-01

MULTRYS Excipient Strategy and Commercial Opportunities

Last updated: August 26, 2026

MULTRYS is a preservative-free, four-element trace-element injection for pediatric patients weighing at least 10 kg who receive parenteral nutrition. Its commercial position depends less on conventional excipient differentiation than on formulation control, container compatibility, supply reliability, and hospital pharmacy workflow. The product contains zinc, copper, manganese, and selenium in an aqueous acidic solution and is administered after dilution into parenteral nutrition solutions.[1]

What is MULTRYS and who markets it?

MULTRYS is a single-dose injectable product marketed by Fresenius Kabi USA, LLC. The product is FDA-approved under NDA 210853 for pediatric patients weighing 10 kg or more who require parenteral nutrition.[1,2]

Attribute	MULTRYS
Active ingredients	Zinc, copper, manganese, selenium
Dosage form	Injection concentrate for intravenous use after dilution
Route	Intravenous, through parenteral nutrition
Target population	Pediatric patients weighing at least 10 kg
FDA approval	February 2019
Manufacturer/marketer	Fresenius Kabi USA, LLC
Preservatives	None identified in the FDA prescribing information
Primary use	Daily trace-element supplementation during parenteral nutrition
Regulatory category	Approved drug product, not a conventional dietary supplement

MULTRYS is used in neonatal, pediatric intensive-care, surgical, oncology, gastroenterology, and home-infusion settings where patients cannot obtain adequate micronutrients through enteral nutrition.

What ingredients and excipients are in MULTRYS?

MULTRYS uses a relatively simple aqueous formulation. The formulation contains four trace-element drug substances and excipient components needed to establish acidity, maintain solution stability, and support parenteral administration.

Component	Function
Zinc sulfate	Zinc source
Cupric sulfate	Copper source
Manganese sulfate	Manganese source
Selenious acid	Selenium source
Hydrochloric acid	pH adjustment and formulation control
Water for injection	Vehicle

The FDA label identifies hydrochloric acid and water for injection as inactive ingredients. The product does not rely on preservatives, surfactants, sugars, amino acids, chelators, or complex lipid excipients.[1]

Why is the excipient profile commercially relevant?

The limited excipient profile reduces several risks associated with pediatric intravenous products:

• Lower risk of preservative exposure in vulnerable patients.
• Reduced potential for excipient-related intolerance.
• Simpler compatibility assessment with parenteral nutrition admixtures.
• Easier characterization of the formulation during stability studies.
• Lower risk of excipient supply disruption compared with complex formulations.

The same simplicity limits conventional formulation patent opportunities. A competitor may be able to develop an alternative aqueous trace-element product without reproducing a complex delivery system.

How does MULTRYS use excipient strategy?

MULTRYS uses a minimalist excipient strategy. The product’s value is concentrated in the composition, concentration, dosing design, and manufacturing controls rather than in a proprietary excipient platform.

pH control

Hydrochloric acid is used to adjust the formulation to an acidic pH. Acidification can support trace-metal solubility and reduce precipitation risk before dilution. The formulation must remain suitable for subsequent addition to parenteral nutrition solutions, which may contain amino acids, dextrose, electrolytes, and lipid emulsions.

pH control creates technical requirements in four areas:

1. Metal solubility during storage.
2. Compatibility after dilution.
3. Control of particulate formation.
4. Container and closure compatibility.

A competitor that changes the acidulant, buffer system, or final pH may gain a formulation distinction, but the change would require evidence that the new system maintains stability and compatibility for intravenous use.

Water for injection

Water for injection is the vehicle. It is a standard parenteral excipient with an established regulatory profile. The commercial challenge is not differentiation but control of:

• Bioburden and endotoxin.
• Particulate matter.
• Sterility assurance.
• Container-closure integrity.
• Trace-metal contamination from manufacturing equipment and components.

Because the drug substances are themselves metals or metalloids, trace contamination and elemental impurities require tighter control than in many conventional injectable products.

No preservative platform

MULTRYS is supplied as a single-dose product and does not require antimicrobial preservatives. This supports pediatric and hospital use but places greater reliance on aseptic processing, container closure, and single-use administration.

A multidose or preservative-containing alternative would have limited commercial appeal in pediatric parenteral nutrition unless it delivered a material cost, storage, or workflow advantage. Regulatory scrutiny would increase because the product would introduce an additional injectable excipient into a high-risk patient population.

What formulation patents protect MULTRYS?

The public FDA labeling establishes the composition and use of MULTRYS but does not, by itself, establish the full scope of any patent estate. Patent protection must be assessed through the FDA Orange Book, USPTO records, and litigation databases.

The most commercially relevant potential claim categories are:

Claim category	Relevance to MULTRYS
Four-element composition	Covers the combination of zinc, copper, manganese, and selenium
Concentration ranges	May protect the relative amount of each trace element
Pediatric dosing	May cover weight-based or age-specific administration
Parenteral nutrition use	May protect use in pediatric patients receiving PN
Solution pH	May protect stability-related formulation parameters
Container system	May protect vial, ampoule, or closure configurations
Manufacturing process	May cover mixing, filtration, filling, or impurity-control steps
Compatibility profile	May support regulatory differentiation but is harder to enforce as a standalone claim

No patent number, expiration date, or Orange Book listing should be attributed to MULTRYS without a current database review. The FDA label and approval letter establish the NDA and approved indication, but they do not provide a complete patent analysis.[1,2]

What is the Orange Book status of MULTRYS?

MULTRYS is an FDA-approved NDA product and should be evaluated in the Orange Book under its NDA listing. Orange Book review should confirm:

• Whether patents are listed for NDA 210853.
• Whether any listed patents cover the formulation, method of use, or drug substance.
• Whether pediatric-use patents are listed.
• Whether a generic applicant has submitted an ANDA.
• Whether any Paragraph IV certification has been made public.

The absence of a prominent publicly known challenge does not establish that no ANDA has been filed. ANDA filings and Paragraph IV notices may become visible through FDA records, court filings, or statutory notice documents at different times.

When does MULTRYS lose exclusivity?

MULTRYS received FDA approval in 2019. The product’s regulatory exclusivity period depends on the precise classification assigned by FDA and any applicable pediatric exclusivity.

For a conventional new chemical entity, five years of new chemical entity exclusivity may run from approval. For a product that does not qualify for NCE exclusivity, three-year exclusivity may apply if approval relied on new clinical investigations conducted or sponsored by the applicant. The commercial entry date, however, may be controlled by listed patents, ANDA litigation, settlement terms, or regulatory exclusivity extensions.[2,3]

Exclusivity issue	Commercial effect
FDA regulatory exclusivity	Can delay ANDA approval
Listed patent	Can delay approval or create litigation risk
Paragraph IV certification	Can trigger patent litigation
Pediatric exclusivity	May add six months to certain existing exclusivities or patents
Formulation patent	Can narrow the ability of a generic to use the same composition
Method-of-use patent	May affect labeling and carve-out strategy
Manufacturing patent	May create process risk without necessarily blocking approval

A reliable loss-of-exclusivity date requires a current Orange Book and patent-family review. An approval date alone does not establish generic entry timing.

What generic entry risks exist for MULTRYS?

MULTRYS has moderate technical barriers and potentially limited formulation complexity. The main generic entry risks are:

Composition replication

The product contains common parenteral trace-element compounds in an aqueous vehicle. A generic applicant may be able to develop a compositionally similar product if patent claims do not block the relevant concentration ranges or use.

Injectable development burden

The product is not a simple oral solid. An ANDA applicant must address:

• Sterility.
• Endotoxin control.
• Particulate matter.
• Elemental impurity control.
• Stability.
• Container-closure integrity.
• Dilution compatibility.
• Drug-product sameness.
• In-use handling after addition to parenteral nutrition.

These requirements increase development cost and manufacturing complexity.

Metal compatibility

Trace metals can interact with amino acids, phosphates, sulfates, lipid emulsions, and other components in parenteral nutrition. Precipitation and adsorption risks can vary by container, tubing, storage temperature, and admixture composition.

A generic product that matches the label but demonstrates weaker compatibility data may face hospital-pharmacy resistance, even if it receives FDA approval.

Supply-chain risk

MULTRYS depends on pharmaceutical-grade trace-element raw materials and sterile injectable manufacturing. Shortages affecting zinc, copper, manganese, selenium, vials, stoppers, or sterile capacity could create opportunities for a second supplier.

Which companies could challenge MULTRYS?

The most credible competitors are companies with sterile injectable, parenteral nutrition, or hospital-product capabilities. Relevant competitive groups include:

Competitor group	Likely advantage
Large parenteral nutrition suppliers	Existing hospital contracts and admixture expertise
Sterile injectable generic manufacturers	ANDA development and low-cost manufacturing
Specialty pediatric injectable companies	Pediatric formulation and clinical-network access
Compounding pharmacies	Rapid local supply but lower scalability and different regulatory status
International trace-element suppliers	Existing products outside the United States

Fresenius Kabi competes in the same broader market as Baxter and other suppliers of parenteral nutrition products and trace-element additives. The exact competitive set differs by country because trace-element products may be registered as drugs, hospital preparations, or nutrition products under local law.

What commercial opportunities exist for MULTRYS excipient innovation?

The most attractive opportunities are not likely to involve adding conventional excipients. They involve improving stability, compatibility, packaging, and administration.

1. Ready-to-use or premixed presentations

MULTRYS is an additive for parenteral nutrition. A ready-to-use or premixed presentation could reduce pharmacy compounding steps, preparation errors, and handling time.

Potential formats include:

• Premeasured syringes.
• Unit-dose bags.
• Pharmacy-ready additive containers.
• Premixed pediatric parenteral nutrition solutions containing trace elements.

The regulatory burden would increase because the product would require validated stability in the final admixture and a broader assessment of container and delivery compatibility.

2. Extended admixture stability

A formulation or packaging system that extends the usable period after dilution could have commercial value. Hospitals and home-infusion providers benefit from longer validated storage periods, particularly where parenteral nutrition is prepared centrally.

Potential technical approaches include:

• Optimized pH.
• Low-adsorption container materials.
• Improved closure systems.
• Reduced headspace oxygen.
• Compatibility-directed concentration adjustments.
• Packaging that limits light or temperature exposure.

Any change must preserve the approved elemental dose and avoid new precipitation or degradation pathways.

3. Low-volume administration

A concentrated product that reduces additive volume could improve pediatric dosing and pharmacy workflow. This opportunity is limited by solubility, osmolality, stability, and safe measurement requirements.

A lower-volume product may be attractive for patients receiving fluid-restricted parenteral nutrition. It could also create a differentiated formulation patent if the concentration range and stability profile are novel and non-obvious.

4. Container and closure innovation

Packaging can create practical differentiation even when the solution composition is similar. Opportunities include:

• Polymer containers with lower metal adsorption.
• Prefilled syringes.
• Needle-free transfer systems.
• Light-protective packaging.
• Clearly differentiated pediatric dose markings.
• Single-use systems that reduce handling errors.

Container patents may provide a narrower but defensible commercial position if the formulation itself is difficult to protect.

5. Global formulation adaptation

Trace-element dosing and approved presentations vary across jurisdictions. A company could use the MULTRYS platform as a basis for country-specific products with:

• Different elemental concentrations.
• Neonatal presentations.
• Adult and pediatric versions.
• Alternative vial sizes.
• Region-specific parenteral nutrition compatibility data.

Geographic expansion would require separate regulatory submissions and may encounter established products such as multi-trace-element injections already used in Europe or other markets.

How does MULTRYS compare with conventional multi-trace-element products?

MULTRYS is differentiated by its pediatric indication, defined weight threshold, four-element composition, and FDA-approved use in parenteral nutrition.

Commercial factor	MULTRYS	Conventional multi-trace-element product
Pediatric positioning	Explicitly pediatric for patients at least 10 kg	May be adult-focused or broader
Element profile	Zinc, copper, manganese, selenium	May include chromium or other elements
Regulatory positioning	FDA-approved drug with pediatric labeling	Varies by product and jurisdiction
Excipient complexity	Low	Usually low, but product-specific
Workflow	Added to PN before administration	May require separate dosing or substitution
Differentiation	Pediatric dose and approved indication	Broader composition or institutional familiarity
Generic risk	Moderate	Depends on patent and formulation status

The omission or inclusion of chromium and other elements can be clinically and commercially important. A competitor with a broader element profile may appeal to institutions seeking one product for multiple patient groups. MULTRYS can retain an advantage where pediatric-specific dosing and FDA labeling drive formulary decisions.

What FDA regulatory issues affect excipient opportunities?

Any new MULTRYS formulation would likely require careful evaluation under FDA drug-product requirements. The regulatory pathway would depend on whether the change is:

• A post-approval manufacturing change.
• A new strength or presentation.
• A new dosage form.
• A new combination product.
• A new product relying on reference-product equivalence.

Key regulatory data would include:

1. Formulation composition and quantitative excipient levels.
2. Sterility and endotoxin validation.
3. Stability under labeled storage conditions.
4. Dilution and admixture compatibility.
5. Container-closure integrity.
6. Extractables and leachables.
7. Particulate characterization.
8. Elemental impurity controls.
9. Pediatric dosing and administration instructions.

An excipient change can affect bioavailability, safety, compatibility, and administration. For an intravenous trace-element product, FDA review is likely to focus on product quality and dosing reliability rather than conventional absorption studies.

What patent strategy is strongest for MULTRYS?

A durable patent estate would combine composition, concentration, use, manufacturing, and packaging claims.

Composition claims

These should cover the four-element combination and commercially relevant concentration ranges. Broad claims may face prior-art challenges because trace-element mixtures are established pharmaceutical products.

Pediatric method-of-use claims

Claims tied to weight-based dosing, pediatric parenteral nutrition, or a defined clinical population may provide meaningful differentiation. Their value depends on FDA labeling, Orange Book listing, and the ability of a generic applicant to omit the protected use.

Stability and compatibility claims

Claims directed to stability after dilution into a parenteral nutrition solution could create a technical barrier. Enforceability may be difficult if the claim depends on a result rather than a clearly defined formulation or process.

Manufacturing claims

Manufacturing claims may protect impurity control, mixing order, filtration, or aseptic filling. They can raise process risk but may not block a competitor using a materially different manufacturing route.

Device and packaging claims

A proprietary transfer device or prefilled presentation could protect the hospital workflow and support product switching costs. This may be the most practical area for follow-on innovation because the base formulation has limited excipient complexity.

What litigation and settlement risks affect MULTRYS?

A Paragraph IV challenge could lead to litigation under the Hatch-Waxman framework if MULTRYS has listed patents and the reference sponsor receives timely notice. The central disputes would likely involve:

• Obviousness of the four-element composition.
• Written description and enablement of concentration ranges.
• Infringement of pediatric method-of-use claims.
• Validity of stability or compatibility claims.
• Non-infringement based on an alternative formulation.
• Labeling carve-outs for protected uses.

A settlement agreement could establish an authorized generic, a fixed entry date, or a license for a competing manufacturer. No settlement terms should be assumed without a filed court document, FTC disclosure, or company announcement.

What revenue exposure does MULTRYS create?

MULTRYS revenue exposure is concentrated in institutional and home-infusion channels rather than retail pharmacy. The highest-value commercial accounts are likely to include:

• Children's hospitals.
• Academic medical centers.
• Pediatric intensive-care units.
• Home parenteral nutrition providers.
• Group purchasing organizations.
• Central pharmacy and compounding networks.

The product’s economic value includes more than vial price. Hospitals may value reduced dosing complexity, fewer compounding steps, and lower medication-error risk. A generic entrant could discount the product while still facing adoption barriers if hospital protocols, compatibility data, or supply reliability favor the incumbent.

Public company filings may not report MULTRYS revenue separately. Product-level revenue exposure therefore cannot be quantified reliably from public information without a company-specific sales disclosure.

Key Takeaways

• MULTRYS is a four-element pediatric trace-element injection for patients weighing at least 10 kg who receive parenteral nutrition.
• Its excipient system is minimal and consists primarily of hydrochloric acid and water for injection.
• The principal technical issues are pH control, metal solubility, admixture compatibility, sterility, particulate control, and container integrity.
• Commercial differentiation is more likely through packaging, ready-to-use formats, stability, and workflow reduction than through conventional excipient additions.
• Generic entry risk is moderate because the composition is relatively simple but sterile injectable and parenteral-nutrition compatibility requirements are demanding.
• The Orange Book, USPTO, and litigation records must be reviewed together to determine patent coverage, Paragraph IV activity, and the actual loss-of-exclusivity timeline.
• The strongest follow-on opportunities are pediatric dose formats, low-volume presentations, extended admixture stability, and validated container or transfer systems.

FAQs

Is MULTRYS a parenteral nutrition product or a trace-element additive?

MULTRYS is a trace-element additive administered after dilution into parenteral nutrition solutions. It is not a complete parenteral nutrition formulation.

Does MULTRYS contain chromium?

The FDA-approved MULTRYS formulation contains zinc, copper, manganese, and selenium. Chromium is not identified as an active ingredient in the FDA prescribing information.[1]

Can MULTRYS be administered directly into a vein?

The product is labeled for intravenous use after dilution. It should be handled according to the prescribing information and institutional parenteral nutrition procedures.[1]

Could a preservative-free generic compete with MULTRYS?

Yes. A preservative-free generic could compete if it satisfies FDA requirements for pharmaceutical equivalence, product quality, stability, sterility, labeling, and any applicable patent or exclusivity restrictions.

Is there a commercial opportunity for a neonatal version of MULTRYS?

Potentially, but a neonatal version would require a separate assessment of elemental dosing, concentration, excipient exposure, administration volume, stability, compatibility, and FDA regulatory requirements. It would also compete with established neonatal trace-element products and institutional compounding practices.

References

1. U.S. Food and Drug Administration. (2019). MULTRYS (trace elements injection 4) prescribing information*. Fresenius Kabi USA, LLC.

2. U.S. Food and Drug Administration. (2019). Approval letter for NDA 210853: MULTRYS. Center for Drug Evaluation and Research.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

4. U.S. Pharmacopeia. (2024). General chapters for pharmaceutical compounding, sterile preparations, and elemental impurities. United States Pharmacopeial Convention.