SODIUM ACETATE Drug Patent Profile

When do Sodium Acetate patents expire, and what generic alternatives are available?

Sodium Acetate is a drug marketed by Amneal, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc. and is included in seven NDAs.

The generic ingredient in SODIUM ACETATE is sodium acetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sodium Acetate

A generic version of SODIUM ACETATE was approved as sodium acetate by HOSPIRA on May 4^th, 1983.

Summary for SODIUM ACETATE

US Patents:	0
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	230
Drug Prices:	Drug price information for SODIUM ACETATE
What excipients (inactive ingredients) are in SODIUM ACETATE?	SODIUM ACETATE excipients list
DailyMed Link:	SODIUM ACETATE at DailyMed

See drug prices for SODIUM ACETATE

Pharmacology for SODIUM ACETATE

Drug Class	Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM ACETATE

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for SODIUM ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	218469-003	Mar 2, 2026	AP	RX	No	No
Somerset Theraps Llc	SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	219826-002	Sep 18, 2025	AP	RX	No	No
Hikma	SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	216920-001	Mar 15, 2024	AP	RX	No	No
Extrovis	SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	220274-001	Apr 17, 2026	AP	RX	No	No

Sodium Acetate Pharmaceutical Market Dynamics and Financial Trajectory

Last updated: August 4, 2026

Sodium acetate is a mature, low-margin pharmaceutical ingredient sold primarily as an injectable electrolyte concentrate and as a component of parenteral nutrition. Its commercial trajectory is driven by hospital demand, manufacturing capacity, supply interruptions, raw-material costs, and contract purchasing rather than by patent exclusivity. Public companies generally do not report sodium acetate revenue separately, so a defensible product-level market size or revenue forecast is unavailable. The financial profile is best characterized as stable but low growth, with episodic price increases during shortages.

What is the pharmaceutical market for sodium acetate?

Sodium acetate is used mainly as an intravenous source of sodium and acetate. Injectable products are administered after dilution and are used in fluid and electrolyte replacement, parenteral nutrition, and selected clinical situations requiring an alkalinizing sodium source. Sodium acetate is also used in dialysis solutions, laboratory reagents, food production, and industrial applications, although those markets are outside the pharmaceutical product market.

Market characteristic	Assessment
Primary pharmaceutical form	Sterile sodium acetate injection or concentrate
Main users	Hospitals, infusion pharmacies, compounding facilities, parenteral nutrition providers
Therapeutic role	Electrolyte replacement, sodium supplementation, acetate-based alkalinization, parenteral nutrition
Product maturity	Mature, off-patent, generic market
Demand growth	Low single-digit or lower in established markets
Pricing power	Limited under normal supply conditions
Main commercial risk	Manufacturing interruption and hospital shortage
Patent dependence	Minimal
Biosimilar exposure	None
Revenue disclosure	Generally not reported separately by manufacturers

Sodium acetate is not a branded growth product. It competes in a procurement-driven market where hospitals typically evaluate price, availability, concentration, container configuration, and vendor reliability.

What FDA regulatory status applies to sodium acetate injection?

Sodium acetate injection is regulated as a prescription sterile injectable product. U.S. product labeling identifies sodium acetate injection as a source of sodium for addition to large-volume intravenous fluids and for clinical uses requiring sodium replacement or acetate administration. The product must be diluted before administration according to labeling and clinical protocols. FDA labeling also identifies risks associated with sodium loading, hypernatremia, fluid overload, and metabolic complications.[1]

FDA status differs by manufacturer and presentation. Products may be marketed under approved abbreviated new drug applications, legacy approval pathways, or, in some cases, regulatory categories requiring careful product-specific verification. A sodium acetate product’s National Drug Code does not by itself establish that every presentation has the same approval pathway.

What are the main sodium acetate injection presentations?

Commercial presentations generally include:

Presentation	Typical commercial role
2 mEq/mL injection	Concentrated hospital electrolyte product
Small-volume vial	Pharmacy-controlled dilution and compounding
Ampule or single-dose container	Institutional administration and emergency stock
Pharmacy bulk package	Large-volume pharmacy preparation, where authorized
Sodium acetate in parenteral nutrition	Component supplied through compounded or commercial nutrition systems

Container closure, concentration, preservative status, single-dose labeling, and pharmacy bulk-package status can materially affect hospital purchasing decisions.

What is the Orange Book status of sodium acetate?

Sodium acetate does not have the commercial profile of an innovator drug with an extensive Orange Book patent estate. The active ingredient is an old inorganic salt, and market protection is not based on a new chemical entity patent.

The relevant Orange Book questions are product-specific:

1. Whether a particular sodium acetate injection has an approved NDA or ANDA.
2. Whether that approval has any listed patents.
3. Whether the listed presentation is therapeutically equivalent to another approved product.
4. Whether the product is included in current FDA reference-product and therapeutic-equivalence records.

FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, is the controlling source for product-level approval, patent, exclusivity, and therapeutic-equivalence information.[2] DailyMed provides manufacturer labeling but is not a substitute for the Orange Book when determining approval status or patent listings.[3]

What patents protect sodium acetate products?

No meaningful composition-of-matter patent protects sodium acetate as an active pharmaceutical ingredient. The salt has been known and used for decades. Any remaining intellectual-property risk is more likely to arise from a specific product configuration or process.

What formulations are protected by sodium acetate patents?

Potentially relevant rights could involve:

• Sterile manufacturing and aseptic processing.
• Container-closure systems.
• Premixed intravenous solutions.
• Stability-enhancing formulations.
• Parenteral nutrition combinations.
• Automated compounding systems.
• Manufacturing controls for concentration, pH, endotoxin limits, or particulate reduction.
• Packaging designed to reduce breakage or improve storage.

These rights would not normally prevent competition with the active ingredient itself. They could affect a particular presentation, manufacturing process, or combination product.

The practical patent assessment is therefore:

Patent category	Commercial significance
Sodium acetate composition patent	Essentially none
New chemical entity exclusivity	None
Basic injectable formulation patent	Generally weak or expired
Container or device patent	Possible, but presentation-specific
Manufacturing-process patent	Possible, with limited blocking power
Parenteral-nutrition combination patent	Relevant only to the claimed combination
Method-of-use patent	Limited opportunity because uses are established
Trade secret and quality systems	More important than patent exclusivity

When does sodium acetate lose exclusivity?

Sodium acetate has no meaningful remaining new-drug exclusivity period. It is an established generic electrolyte product, and the principal commercial protections associated with new chemical entities, orphan drugs, pediatric extensions, or novel clinical indications do not drive this market.

The relevant market-entry timing is controlled by:

• FDA approval of a competing injectable.
• Availability of sterile fill-finish capacity.
• Drug shortage conditions.
• Hospital formulary conversion cycles.
• Contracting windows with group purchasing organizations.
• State and federal procurement requirements.
• Product-specific manufacturing validation.

There is no single, commercially decisive sodium acetate patent expiration date comparable to those for protected branded drugs.

Which companies compete in the sodium acetate market?

The U.S. market has historically included large generic injectable manufacturers and hospital-supply companies. Manufacturer participation can change as products are discontinued, acquired, transferred, or temporarily unavailable.

Companies associated with the broader generic injectable and electrolyte market include:

• Pfizer and Hospira.
• Fresenius Kabi.
• Baxter International.
• Hikma Pharmaceuticals.
• Sagent Pharmaceuticals, now part of Nichi-Iko’s former U.S. commercial landscape in relevant product categories.
• Smaller 503B outsourcing facilities and regional compounders.
• Contract manufacturers supplying hospital and nutrition companies.

The existence of a manufacturer in this category does not establish current availability of every sodium acetate presentation. FDA’s National Drug Code Directory, DailyMed, manufacturer labeling, and shortage records must be reconciled for current commercial status.[3,4]

What patent litigation affects sodium acetate?

Sodium acetate has no well-known patent-litigation profile comparable to high-value branded pharmaceuticals. Litigation risk is more likely to involve:

• Product liability.
• Sterility failures.
• Contamination or particulate claims.
• Contract disputes.
• Manufacturing or supply agreements.
• Compounding-facility compliance.
• Antitrust or shortage-related commercial conduct.

Paragraph IV litigation is not a central feature of the market. A generic applicant could theoretically file a Paragraph IV certification against a listed patent associated with a specific approved product, but the old active ingredient and limited patent estate make such a dispute commercially less significant than in markets involving protected formulations or methods of use.

What generic entry risks exist for sodium acetate?

Generic entry risk is structurally high because:

• The active ingredient is old and inexpensive.
• Clinical use is well established.
• The product is generally simple from a pharmaceutical perspective.
• There is no meaningful biological-comparability barrier.
• Hospital buyers often have experience switching between equivalent electrolyte products.
• Competing products can be sourced from multiple regions.

The main barrier is sterile manufacturing, not intellectual property. Injectable products require validated aseptic processes, reliable raw materials, environmental controls, container-closure testing, particulate control, endotoxin testing, and regulatory inspection readiness.

How do manufacturing barriers affect competition?

Sodium acetate illustrates the difference between low patent risk and high operational risk. A manufacturer may be able to develop the product without major formulation innovation but still face substantial capital and compliance requirements.

Barrier	Effect on market
Sterile fill-finish capacity	Limits the number of reliable suppliers
FDA inspection findings	Can remove capacity quickly
Glass vial or ampule shortages	Interrupts finished-product supply
Raw-material qualification	Delays alternate sourcing
Small market volume	Reduces incentive to add capacity
Hospital contract concentration	Makes winning share difficult
Shortage notification and allocation	Can produce temporary pricing volatility

This structure favors established injectable manufacturers with validated plants and hospital distribution networks.

How does sodium acetate compare with sodium bicarbonate and sodium chloride?

Sodium acetate competes indirectly with other sodium-containing injectable products.

Product	Main role	Competitive relationship
Sodium acetate injection	Sodium and acetate source; alkalinizing use after metabolism	Used when acetate is clinically or operationally preferred
Sodium bicarbonate injection	Direct bicarbonate administration and acid-base management	Alternative in selected alkalinizing indications
Sodium chloride injection	Volume and sodium replacement	Dominant basic electrolyte comparator
Potassium acetate injection	Potassium and acetate replacement	Relevant in parenteral nutrition and electrolyte correction
Sodium phosphate injection	Sodium and phosphate replacement	Used when phosphate replacement is required

Sodium acetate is not a direct substitute for all sodium chloride or sodium bicarbonate demand. Clinical substitution depends on the indication, acid-base status, renal function, electrolyte requirements, concentration, and institutional protocols.

What drives sodium acetate pharmaceutical revenue?

Revenue is primarily determined by volume and supply conditions rather than innovation.

Hospital utilization

Demand comes from intensive-care units, inpatient pharmacies, nutrition-support teams, dialysis programs, and compounding services. Utilization is relatively predictable and linked to hospital admissions, parenteral nutrition volume, and electrolyte-management protocols.

Shortages and allocation

Shortage events can cause sharp temporary changes in price and market share. The FDA Drug Shortages database and the American Society of Health-System Pharmacists shortage resources are important monitoring tools.[4,5] A shortage can increase the value of inventory, but it does not necessarily create durable profitability because hospitals may switch suppliers or use clinically acceptable alternatives.

Group purchasing

Large hospital systems and group purchasing organizations exert strong price pressure. Contracts can concentrate demand among a small number of suppliers while lowering unit margins.

Input costs

The active ingredient is inexpensive, but total cost includes:

• Sterile production.
• Labor and quality control.
• Packaging.
• Freight and storage.
• Regulatory compliance.
• Plant maintenance.
• Inventory carrying costs.
• Recall and shortage-management costs.

For a low-value injectable, fixed manufacturing and compliance costs can be more important than the cost of sodium acetate itself.

What is the financial trajectory for sodium acetate?

There is no reliable public standalone revenue series for sodium acetate injection from major manufacturers. Companies generally include the product within broader generic injectable, hospital products, nutrition, or pharmaceutical-solutions segments.

The likely financial trajectory is:

Period	Expected market condition
Short term	Stable baseline demand with price volatility during supply disruptions
Medium term	Low volume growth, continued generic price pressure, periodic supplier exits
Long term	Mature demand; profitability depends on manufacturing efficiency and supply reliability

A reasonable commercial model is a flat-to-low-growth market in normal conditions, interrupted by temporary revenue spikes during shortages. Those spikes may benefit suppliers with available inventory but can be offset by higher production, quality, freight, and remediation costs.

Sodium acetate is therefore more valuable as part of a broader hospital injectable portfolio than as a standalone growth asset. A supplier can improve economics through portfolio bundling, shared manufacturing infrastructure, dependable distribution, and contract access.

Are licensing deals important for sodium acetate?

Licensing activity is limited compared with patented drugs, biologics, or delivery technologies. The most relevant commercial arrangements are likely to be:

• Contract manufacturing agreements.
• Authorized generic supply arrangements.
• Product transfers between injectable manufacturers.
• Hospital and group-purchasing contracts.
• Distribution agreements.
• Outsourcing arrangements for pharmacy bulk products.
• Parenteral-nutrition supply contracts.

A license involving sodium acetate would generally concern a formulation, device, manufacturing method, or distribution right rather than ownership of the active ingredient.

What is the biosimilar risk for sodium acetate?

There is no biosimilar risk. Sodium acetate is a small-molecule salt, not a biologic. Competition occurs through generic drug approval, therapeutic equivalence, manufacturing capacity, and procurement contracts.

The relevant regulatory risks are generic-drug and sterile-manufacturing risks, including:

• ANDA review.
• Product-specific bioequivalence or quality requirements.
• Sterility assurance.
• Drug Master File qualification.
• FDA inspection outcomes.
• Labeling and container-closure compliance.

What geographic markets matter?

The United States is commercially important because hospitals rely heavily on injectable generic suppliers and shortage conditions can affect national procurement. Europe, Canada, Japan, and emerging markets also use sodium acetate in hospital and nutrition settings, but regulatory classifications, reimbursement, purchasing structures, and product availability differ.

Geographic coverage depends on:

• Local registration requirements.
• Pharmacopeial standards.
• Import controls.
• Sterile manufacturing location.
• Regional distribution.
• Hospital tender systems.
• Local compounding rules.

A manufacturer with only one qualified sterile plant has greater geographic and supply-chain exposure than a company with redundant sites.

What generic launch scenarios are most likely?

Base case

Existing suppliers maintain production, demand remains stable, and prices trend downward or remain flat under hospital contracting. Revenue grows little, if at all.

Shortage-driven upside

A competitor experiences a plant shutdown, inspection issue, raw-material problem, or packaging interruption. Available suppliers gain temporary volume and may obtain higher prices.

New entrant scenario

A new manufacturer enters after securing FDA approval and validated sterile capacity. The entrant captures share through reliable supply, competitive pricing, or a differentiated package configuration.

Downside scenario

A major supplier exits, but hospitals respond by substituting sodium bicarbonate, sodium chloride, potassium acetate, or compounded alternatives where clinically appropriate. The market contracts in the affected presentation even if total electrolyte demand remains stable.

How strong is the sodium acetate patent estate?

The patent estate is weak as a commercial barrier. The active ingredient is old, generic, and not protected by meaningful new-chemical-entity rights. The stronger barriers are operational:

1. FDA-compliant sterile manufacturing.
2. Consistent product quality.
3. Hospital purchasing access.
4. Reliable inventory.
5. Shortage-response capability.
6. Validated packaging and distribution.
7. Manufacturing redundancy.

For investors and licensing teams, sodium acetate is best assessed as a supply-chain and manufacturing asset, not as a patent-protected pharmaceutical franchise.

Key Takeaways

• Sodium acetate is a mature generic injectable electrolyte product.
• Its active ingredient has no meaningful remaining composition-of-matter exclusivity.
• Orange Book and approval status must be evaluated by manufacturer and presentation.
• Paragraph IV litigation and biosimilar competition are not central market risks.
• Sterile manufacturing capacity is the main barrier to entry.
• Revenue is not publicly reported as a standalone product category.
• Normal-market growth is likely limited, while shortage periods can create temporary price and share volatility.
• Commercial value depends on hospital contracts, product availability, quality systems, and manufacturing redundancy.
• The product is more strategically useful within a broader injectable or parenteral-nutrition portfolio than as an independent high-growth asset.

FAQs About Sodium Acetate Pharmaceutical Market and Exclusivity

Is sodium acetate injection an FDA-approved drug?

Some sodium acetate injection products are marketed under FDA-regulated approval pathways, but approval status is product-specific. The applicable source is the FDA product record for the particular manufacturer, strength, container, and NDC.

Does sodium acetate have an Orange Book patent?

Sodium acetate itself is not protected by a meaningful active ingredient patent. Any Orange Book patent listing would have to be assessed against a specific approved product and presentation.

Can hospitals substitute sodium bicarbonate for sodium acetate?

Substitution depends on the clinical indication, electrolyte requirements, acid-base status, renal function, concentration, and institutional pharmacy policy. The two products are not universally interchangeable.

Why can a low-cost sodium acetate product experience shortages?

The active ingredient is inexpensive, but sterile manufacturing, vial or ampule supply, quality-control capacity, and regulatory compliance can constrain production. A single plant interruption can affect a large share of supply.

Is sodium acetate a good pharmaceutical licensing target?

It is generally a low-value standalone licensing target. Its commercial attractiveness improves when combined with sterile injectable capacity, hospital distribution, parenteral-nutrition products, or a differentiated container and supply platform.

References

1. DailyMed. (n.d.). Sodium acetate injection, USP prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

3. U.S. National Library of Medicine. (n.d.). DailyMed: Official labeling for marketed drugs. https://dailymed.nlm.nih.gov/dailymed/

4. U.S. Food and Drug Administration. (n.d.). Drug shortages. https://www.accessdata.fda.gov/scripts/drugshortages/

5. American Society of Health-System Pharmacists. (n.d.). Drug shortages. https://www.ashp.org/drug-shortages