Last Updated: May 11, 2026

MAGNESIUM SULFATE IN PLASTIC CONTAINER Drug Patent Profile


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When do Magnesium Sulfate In Plastic Container patents expire, and what generic alternatives are available?

Magnesium Sulfate In Plastic Container is a drug marketed by Amneal, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland, Hospira, Hq Spclt Pharma, Milla Pharms, and Mylan Labs Ltd. and is included in eight NDAs.

The generic ingredient in MAGNESIUM SULFATE IN PLASTIC CONTAINER is magnesium sulfate. There are one hundred and forty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Magnesium Sulfate In Plastic Container

A generic version of MAGNESIUM SULFATE IN PLASTIC CONTAINER was approved as magnesium sulfate by FRESENIUS KABI USA on September 8th, 1986.

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Summary for MAGNESIUM SULFATE IN PLASTIC CONTAINER
Recent Clinical Trials for MAGNESIUM SULFATE IN PLASTIC CONTAINER

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SponsorPhase
Queen Savang Vadhana Memorial Hospital, ThailandNA
Assiut UniversityPHASE1
Hennepin Healthcare Research InstitutePHASE1

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US Patents and Regulatory Information for MAGNESIUM SULFATE IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 216597-001 Feb 15, 2023 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hq Spclt Pharma MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 207350-001 Dec 6, 2017 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Milla Pharms MAGNESIUM SULFATE IN PLASTIC CONTAINER magnesium sulfate INJECTABLE;INJECTION 209642-002 Nov 8, 2021 AP RX 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

Market Dynamics and Financial Trajectory for Magnesium Sulfate in Plastic Container

Last updated: April 25, 2026

What is the product and how is it typically sold?

Magnesium sulfate in plastic container is an injectable magnesium salt product used for indications that include seizure prophylaxis and treatment in obstetric care, acute hypomagnesemia, and selected cardiology uses (protocol-driven). The “plastic container” qualifier typically refers to ready-to-administer parenteral presentations in plastic (e.g., flexible) containers rather than glass vials.

From a market-structure perspective, magnesium sulfate is a mature, high-volume hospital drug. Demand is driven by:

  • Hospital admissions and protocol adherence (especially obstetrics and critical care)
  • Formulary decisions and group purchasing organization (GPO) contracting
  • Direct procurement by health systems with tendering cycles
  • Regulatory availability and supply continuity

How do pricing and purchasing mechanics shape revenue?

Pricing for magnesium sulfate is usually characterized by:

  • Competitive, commodity-like pricing across manufacturers and labeled strengths
  • Tender- and contract-driven procurement at hospital systems and distributors
  • Margin compression due to mature alternatives and biosimilar-style competition dynamics (though not biosimilars here, the same “single molecule, multiple sources” pressure applies)

Revenue drivers

Revenue trajectories for magnesium sulfate formulations in plastic containers typically depend on:

  1. Unit volume (doses) multiplied by contracted net price
  2. Share of supply in accounts with preference for a given container type
  3. Regulatory and supply continuity (interruptions raise short-term price but hurt sustained share)

Cost and margin drivers

  • Manufacturing scale and fill-finish efficiency dominate unit economics
  • Container supply chain (plastic container availability, resin/film costs, and supplier capacity) can swing gross margin
  • Distribution logistics can improve or worsen landed cost depending on container geometry and shipping density

What market dynamics govern demand stability?

Magnesium sulfate demand tends to be stable-to-defensive because use is anchored to acute care pathways. The primary market-dynamics variables are:

Indication mix and utilization

  • Obstetric utilization: magnesium sulfate use tracks births and higher-risk pregnancy protocols.
  • Hospital acuity: critical care admissions can increase use even outside obstetrics.
  • Treatment protocol inertia: once protocols embed magnesium sulfate, switching tends to be slower than in elective markets.

Substitution and therapeutic equivalence

Because magnesium sulfate is the same active ingredient:

  • Switching between suppliers is common when formularies permit.
  • Container type can influence purchasing decisions (handling, packaging preference, supply reliability), but it rarely enables premium pricing at scale.

Supply chain and manufacturing capacity

For injectable generics and hospital drugs, revenue trajectory often hinges on:

  • Availability windows: shortages can move volume to whichever suppliers can deliver.
  • Regulatory approvals and batch release: delays can cause revenue displacement.
  • Container continuity: if plastic container inputs tighten, the entire finished dosage availability can lag even when API supply is sufficient.

What is the competitive landscape for magnesium sulfate in plastic containers?

The competitive set is typically organized by:

  • Authorized generic and branded generic manufacturers
  • Formulation variants (concentration, volume, container geometry, and whether it is single-dose or multi-dose)
  • Tender performance (delivery reliability, contract compliance, pharmacovigilance documentation)

In mature injectable markets, competition compresses pricing, so winners usually gain by:

  • Sustained supply reliability
  • Better contracting terms
  • Favorable container handling logistics for hospital procurement teams

How do container choice and packaging influence adoption?

Plastic container adoption can affect adoption rates via operational attributes:

Operational decision factors

  • Handling and administration workflow in ED, ICU, and labor and delivery units
  • Storage and shelf management (space efficiency and stacking)
  • Safety and usability perceptions (e.g., reduced breakage risk relative to glass)
  • Nursing and pharmacy preferences in high-throughput settings

Commercial impact

In most cases, container type influences:

  • Account-level switching and distribution preference more than it changes molecule-level demand.
  • The financial trajectory shifts through share-of-account gains or losses rather than pricing power.

What does the financial trajectory typically look like for this product class?

Magnesium sulfate is a mature injectable with:

  • Limited innovation edge unless the product has special packaging, stability, or regulatory differentiation
  • Low pricing elasticity at the hospital level because clinicians treat acute conditions where alternatives exist but procurement constraints dominate

A typical financial trajectory for magnesium sulfate in plastic containers is:

  • Early period: modest growth tied to new contract wins and distributor penetration; margins are set by initial batch economics and container supply.
  • Mid period: volume growth slows as contracts mature; price declines through competition and tender cycles.
  • Late period: revenue stabilizes or declines slightly with generic erosion, while volume may remain stable if supply is reliable and the product remains in formularies.

Key metrics that determine the trajectory

  • Net price per dose (contracted vs list)
  • Volume shipped (by GPO/distributor and hospital accounts)
  • Gross margin per unit (container costs and manufacturing yield)
  • Share retention after supplier changes or tender refresh cycles
  • Quality and supply events (batch failures can cause abrupt volume loss)

What are the main risks and upside levers to watch?

Downside risks (most common)

  • Tender-driven net price erosion across large accounts
  • Generic supply substitution by alternative suppliers
  • Container supply constraints impacting fill-finish and release schedules
  • Regulatory or manufacturing quality events that force recall or temporary withdrawal

Upside levers (most common)

  • Contract wins in obstetrics and ICU bundles
  • Shortage displacement if competitors face capacity constraints (short-term volume lift)
  • Improved packaging logistics that helps distribution density and reduces handling friction
  • Hospital system standardization around a plastic container format

How should R&D and investment decisions be framed for this target?

For magnesium sulfate in plastic container, the investment thesis generally does not rest on new clinical efficacy. It rests on execution advantages in:

  • Cost-to-serve (manufacturing yield, procurement of container components, packaging line efficiency)
  • Supply reliability (batch release performance and contingency capacity)
  • Commercial access (GPO and IDN contracting capability)
  • Regulatory throughput (fast, stable CMC documentation and batch documentation systems)

If the company has a differentiated manufacturing or packaging capability, the financial path improves by:

  • Reducing unit cost volatility
  • Securing long-term supply agreements
  • Locking accounts before tender pricing compresses margins

What data should be used to model revenue and profit realistically?

Because this is a hospital commodity injectable, modeling should focus on contracted volume and net price, not market “demand growth.” The practical model structure is:

Revenue model (minimum viable)

  • Revenue = (Doses shipped) x (Net price per dose)
  • Doses shipped = (Account penetration) x (Utilization per account) x (Formulary share)

Profit model

  • Gross profit = Revenue - (API + excipients) - (manufacturing conversion) - (plastic container and packaging) - (fill-finish consumables)
  • Operating profit adds: regulatory overhead, quality systems, pharmacovigilance, and distribution expenses

Scenario approach

  • Base case: stable volume with gradual net price compression
  • Downside: tender repricing and container shortages
  • Upside: contract wins plus share gain via supply reliability

What is missing for a specific financial forecast, and what is determinable from market structure?

No company-specific sales figures, unit volumes, pricing history, or container-format market shares are provided here. A numerical forecast for this exact product cannot be produced without those inputs.

What is determinable from market structure:

  • Financial trajectory for mature magnesium sulfate injectables is volume-driven and tender-sensitive
  • Plastic container selection changes account share more than it changes pricing
  • Margins track container cost and manufacturing yields, with swings from supply continuity

Key Takeaways

  • Magnesium sulfate in plastic container is a mature, hospital-led injectable where demand is tied to acute care protocols, not consumer cycles.
  • Revenue is driven mainly by contracted net price and dose volume, with pricing compression as the dominant long-run effect.
  • Plastic container packaging influences operational adoption and account share, but it rarely creates durable pricing power across large tendered accounts.
  • Financial performance hinges on supply reliability, container supply continuity, and fill-finish economics, which determine whether the product gains or loses formulary share during tender refreshes.
  • For modeling and investment decisions, focus on net revenue per dose, dose volume by contract channel, and unit gross margin drivers rather than speculative demand growth.

FAQs

  1. Does plastic packaging increase magnesium sulfate pricing power?
    Usually it does not. It more often affects account preference and supply continuity, which change volume share.

  2. What is the primary demand driver for magnesium sulfate injectables?
    Hospital acute care utilization, especially obstetrics and critical care protocols.

  3. How do tender cycles affect revenue?
    Tender refreshes typically drive net price erosion and can reallocate volume among suppliers based on delivery reliability and contract terms.

  4. What supply-chain factor can most directly disrupt availability?
    Plastic container input and container supplier capacity, which can delay fill-finish even when the API supply is adequate.

  5. Where is the best route to margin improvement in this category?
    Reducing unit manufacturing and packaging costs through yield improvements, efficient fill-finish operations, and stable container procurement.

References

[1] FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ASHP. Drug Shortages. American Society of Health-System Pharmacists. https://www.ashp.org/drug-shortages

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