When will the MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% patents expire, and when will MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% 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
B Braun	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	mannitol	INJECTABLE;INJECTION	016080-007	Approved Prior to Jan 1, 1982		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

Executive summary

Mannitol 5% with dextrose 5% in sodium chloride 0.12% is an IV combination infusion used for osmotherapy and fluid/electrolyte support. It is widely treated by investors as a “low-IP, high-volume” generic/commodity category unless a specific product line has enforceable formulation, container/closure, or method-of-use IP, or unless supply is constrained. In the absence of a clearly identifiable brand owner patent estate, FDA listed drug exclusivities, and current Orange Book listings tied to a single NDA/BLA, the investment case is driven primarily by (1) manufacturing scale and sterility/QA throughput, (2) contracting and tender wins in hospital systems, (3) wholesaler and GPO pricing dynamics, and (4) regulatory and supply-risk events rather than durable patent-led cash flows.

What is Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12% and what are the typical clinical uses?

This product is an IV solution combining:

Mannitol (osmotic agent; commonly used to increase plasma osmolality and promote diuresis in indications such as elevated intracranial pressure, among other osmotherapy settings).
Dextrose (5%) as an energy source and to balance the osmotic profile of the infusion.
Sodium chloride 0.12% to contribute to isotonicity/tonicity targets relative to specific institutional protocols.

Where value is captured in practice: utilization is often protocol-driven (ICU and perioperative pathways), so buying decisions skew to supply reliability, price stability, and formulary inclusion rather than prescriber-specific brand preference.

What is the dosing form and route?

Route: intravenous infusion.
Strength: mannitol 5% with dextrose 5% and sodium chloride 0.12%.
Packaging: typically sterile infusion containers; exact container type (bag vs bottle; sizes) affects regulatory listing and logistics economics.

What patents protect Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12%?

Answer for investors: In most markets, multi-component IV fluids with mannitol and dextrose are treated as low-patentability products, with protection (when it exists) concentrated in narrow areas:

Specific formulation ratios beyond generic “manifold” combinations
Container-closure compatibility and extractables/leachables
Manufacturing process controls for sterility assurance and stability
Labeling-driven method-of-use claims (less common for commodity fluids)

Commercial implication: absent a named, enforceable patent estate tied to a specific NDA holder, the economic model is closer to generic sterile liquids: margins compress after entry, and differentiation comes from execution.

What is the Orange Book status of Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12%?

The Orange Book (FDA Approved Drug Products with Therapeutic Equivalence Evaluations) is the authoritative source for:

Approved NDA/BLA listings
Patent numbers
Exclusivities and expiration dates

Investment implication: to model exclusivity-led pricing power, investors need:

A specific NDA/BLA anchor for the exact strength and composition
Listed patents (if any) for that NDA
Any periods of exclusivity not yet expired

Without a mapped FDA listing for this exact combination strength, the conservative investment stance is that pricing power is not patent-locked and will track commodity generic behavior.

When does the product lose exclusivity and how do generics enter?

Typical pathway in IV solution categories: after the originator’s regulatory milestones and patent/exclusivity windows end, new entrants file abbreviated submissions where permitted and compete on:

Acquisition price
GPO contract awards
Supply continuity and lead times
Sterile manufacturing capacity

Investment model: revenue durability is usually tied to uninterrupted supply and negotiated pricing, not to long-lived exclusivity.

What generic entry risks exist for Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12%?

Key generic entry risks in this class:

Rapid price deflation once multiple manufacturers supply the same strength
Procurement shocks from tender cycles and bid/award processes
Shortage-driven repricing followed by normalization when additional capacity comes online
Labeling or container-type divergence that delays interchangeability in some formularies

Barriers that still matter even in “commodity” IV fluids:

Sterile manufacturing line availability
Quality system robustness and batch release timelines
Stability and compatibility validation for container systems
Regulatory inspection outcomes

What formulation patents or container-closure IP can still create moat?

Even when active pharmaceutical ingredient concepts are not protectable, sterile infusion products can still have pockets of enforceable advantage, especially if an NDA supports:

Narrowly claimed ratios or solubilization/stability claims
Specific buffer and tonicifying combinations that impact stability and pH
Container-closure innovations that reduce leachables or particulate matter
Manufacturing method claims tied to validated in-process controls

Investment implication: if an investor can tie a moat to a mapped patent family attached to the exact NDA listing, downside risk from generic competition can be materially reduced. Without that mapping, the moat is operational rather than legal.

What is the regulatory pathway in the US (NDA vs ANDA) and what FDA milestones matter?

For investors, the relevant milestones are:

NDA approval and any exclusivity periods
Post-approval supplements (changes in manufacturing site, container, scale-up)
Inspections and facility status changes
Product discontinuations and shortages

Commercial sensitivity: sterile IV injectables can be disrupted by quality events, raw material sourcing problems, or facility downtime. These are “execution risk” drivers that can temporarily improve pricing even in generic categories.

What litigation or Paragraph IV risk affects this category?

In many sterile IV fluid combinations, Paragraph IV challenges are less prominent than for branded, high-sales small molecules because the category often behaves as generic from early in its life cycle. Where litigation exists, it is typically driven by:

Patent disputes about specific formulation/process claims
Disagreements about equivalence and labeling
Orange Book listing disputes tied to narrow patents

Investment implication: absent a mapped patent dispute environment tied to the exact combination strength, litigation-driven settlements are not the base-case revenue driver.

Which companies manufacture and sell Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12%?

A credible investment screen requires a manufacturer list tied to the exact FDA strength/composition and dosage form. That mapping depends on the Orange Book “active ingredient” and “strength” matching the precise label.

Business reality: market participants are usually contract sterile manufacturers and GxP-focused generics with mature IV lines, plus distributors selling under their own label.

How does this product compare with other osmotic diuretic IV fluids (e.g., mannitol-only or dextrose-saline regimens)?

Competitive substitution: clinicians may choose among:

Mannitol-only products (osmotic agent without dextrose)
Dextrose-containing IV fluids (for energy and fluid balance)
Saline-only options adjusted to institutional tonicity targets

Investment impact: substitution elasticity is dictated by protocol. If protocols specify the mixed composition, volume is stickier. If not, the product competes more directly on availability and price.

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

Demand drivers

Hospital and ICU admission volumes
Perioperative case volume and neurosurgical/trauma protocols using osmotherapy
Inventory management cycles and substitution practice

Pricing and margin dynamics

Competitive bidding and GPO-driven contracting
Multi-manufacturer pressure leading to margin compression
Temporary margin lift during supply disruptions

Investor read-across: this category typically resembles other sterile, multi-source IV solutions where revenue is stable but profit is capped unless supply constraints or operational advantages persist.

What supply chain and manufacturing risks matter for investors?

Sterile IV products are exposed to:

Single-site manufacturing dependencies
Quality system disruptions after deviations or sterility assurance failures
Sterile line utilization and downtime
Commodity input costs (salts, dextrose feedstocks) and packaging costs (bags, closures)

Fundamentals lens: an investor benefits more from producer selection and manufacturing execution than from patent tracking.

Investment scenario framework: three base cases for this product class

Base case 1: Generic commodity with multiple suppliers

Revenue growth aligns with market demand and formulary penetration
Pricing declines with entry count
EBITDA margin largely tied to manufacturing yield, scrap, and compliance costs

Base case 2: Limited supply due to manufacturing constraints

Short-term pricing uplift during shortages
Risk of revenue volatility due to capacity restoration
Higher valuation for producers with validated extra capacity

Base case 3: Niche differentiation via mapped IP or formulation exclusivity

If an identifiable NDA/patent estate blocks interchangeable approvals, downside risk reduces
Requires concrete evidence of enforceable patents/Orange Book listings tied to the exact strength

What due diligence should drive an investment decision (without relying on patent-led narratives)?

For this specific product, the most actionable diligence items are:

Confirm the exact FDA listing for the strength and composition and identify the holder(s)
Map approval history and any manufacturing changes tied to site moves
Identify current market supplier concentration by container size and label configuration
Track quality inspection history and any recalls/discontinuations impacting allocation
Quantify contracting exposure to major IDNs and GPOs

Key Takeaways

This IV combination is a sterile, protocol-driven commodity category; durability typically hinges on manufacturing execution and supply stability rather than long-lived patent protection.
Patent strength and Orange Book status must be mapped to the exact FDA listing for this precise strength; without that anchor, the base-case is generic competition and margin compression.
Investment edge is most often operational: sterile capacity, yield, batch release performance, and contract award velocity.

FAQs

1) How should investors model revenue for sterile IV solutions like mannitol-dextrose-saline combinations?
Use utilization and formulary penetration for volume, then tie pricing to GPO/contract cycles and multi-source supply dynamics; margin follows yield and compliance cost.

2) What are the fastest signals that supply constraints could lift pricing for this category?
Facility capacity downtime indicators, batch release delays, retailer allocation changes, and sudden discontinuation notices for the same strength/container configuration.

3) Does container choice (bag vs bottle) change interchangeability and procurement?
Yes; procurement systems and conversion protocols can treat container/size variations as distinct SKUs affecting switching speed.

4) What quality events most often hit sterile injectable IV fluids financially?
Inspection outcomes, sterility assurance deviations, particulate/clarity issues, and packaging seal/leaker problems that trigger hold/reject and revalidation costs.

5) Are method-of-use or stability patents relevant for investors in IV fluid combinations?
They can be relevant only if tied to an enforceable, mapped FDA listing; otherwise the market behaves as generic and differentiation is operational.

References (APA)

FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% Drug Patent Profile

Which patents cover Mannitol 5% W/ Dextrose 5% In Sodium Chloride 0.12%, and what generic alternatives are available?

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Questions you can ask:

Summary for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

US Patents and Regulatory Information for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

Investment Scenario and Fundamentals Analysis for Mannitol 5% With Dextrose 5% in Sodium Chloride 0.12% (IV Infusion)