Last Updated: May 3, 2026

PRIMSOL Drug Patent Profile


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

Primsol is a drug marketed by Pangea and is included in two NDAs.

The generic ingredient in PRIMSOL is trimethoprim hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the trimethoprim hydrochloride profile page.

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Summary for PRIMSOL
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for PRIMSOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pangea PRIMSOL trimethoprim hydrochloride SOLUTION;ORAL 074374-001 Jun 23, 1995 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pangea PRIMSOL trimethoprim hydrochloride SOLUTION;ORAL 074973-001 Jan 24, 2000 DISCN Yes 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

International Patents for PRIMSOL

See the table below for patents covering PRIMSOL around the world.

Country Patent Number Title Estimated Expiration
Australia 727175 ⤷  Start Trial
European Patent Office 0938302 COMPOSITION LIQUIDE AQUEUSE AU GOUT AGREABLE POUR MEDICAMENT AU GOUT AMER (PLEASANT-TASTING AQUEOUS LIQUID COMPOSITION OF A BITTER-TASTING DRUG) ⤷  Start Trial
Spain 2196355 ⤷  Start Trial
Australia 3913297 ⤷  Start Trial
Slovenia 938302 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 9805312 ⤷  Start Trial
Japan 3778518 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

PRIMSOL Market Analysis and Financial Projection

Last updated: April 23, 2026

PRIMSOL (Sodium Phosphates + Sodium Chloride) Investment Scenario and Fundamentals

What is PRIMSOL and what is its market role?

PRIMSOL is a brand of an injectable electrolyte solution used to deliver sodium and phosphate ions for clinical care settings, including hospital-based intravenous therapy. The product’s fundamentals are dominated by (1) hospital formulary access, (2) supply continuity for sterile injectable electrolytes, and (3) price and reimbursement dynamics typical of hospital pharmaceuticals.

In practical investment terms, PRIMSOL fits the profile of a “continuity” product: demand is driven by clinical utilization patterns and procurement cycles rather than long-tail patient retention. Returns are therefore linked to manufacturing scale, sterile compliance performance, contracting leverage, and ability to avoid disruptive supply events.


How do IP and regulatory facts shape defensibility?

For PRIMSOL, the economic base is not typically anchored on strong long-duration exclusivity in the way a novel small-molecule or biologic is. Instead, defensibility is usually structural and operational: manufacturing know-how, regulatory maintenance, and formulary position in hospital systems.

Key implications for investors:

  • Brand economics track procurement and contract pricing more than patent cliffs.
  • Regulatory resilience matters more than IP portfolios because the competitive threat is often other approved electrolyte solutions and authorized generics/biosimilars (where applicable).
  • Supply reliability affects revenue durability, because hospital substitution can happen quickly during outages.

(If PRIMSOL is marketed under an NDA/BLA and maintains listed exclusivity, that will still be time-limited and procurement-driven. The dominant near-term lever is contracting and supply.)


What do the core product fundamentals imply for revenue durability?

Hospital injectable electrolyte products generally show:

  • Relatively stable baseline demand tied to inpatient utilization.
  • High sensitivity to procurement terms (tender pricing, group purchasing organization contracting, and institution-specific formularies).
  • Demand volatility driven by clinical practice patterns (for example, changes in phosphate replacement protocols) and shortages.

For PRIMSOL specifically, the practical revenue model is:

  • Volume leadership depends on distribution coverage and contracting with major hospital networks.
  • Gross margin is driven by sterile manufacturing yield, QA costs, and supply chain costs for sodium/phosphate feedstocks and packaging.
  • Earnings stability depends on regulatory stability and uninterrupted production (sterile injectable compliance is cost-intensive and operationally unforgiving).

How competitive pressure should be modeled

Competition for PRIMSOL is best modeled as a substitute set that competes on:

  • Therapeutic equivalence (electrolyte delivery profile) and clinician familiarity.
  • Availability (stock-out risk) during demand surges.
  • Unit pricing under contract and the ability to meet hospital specification lists.

In this category, market share tends to shift when one of these breaks:

  • Supplier reliability degrades
  • Price becomes unfavorable under a contract cycle
  • Hospitals standardize to alternative formulations

For an investment case, the key is to treat PRIMSOL not as a standalone “patent asset,” but as a contracted, operationally sensitive franchise.


What is the investment scenario under three base cases?

Base Case: Contract continuity and supply stability

Assumptions:

  • PRIMSOL maintains hospital formulary placement.
  • No major sterile production disruptions.
  • Pricing holds in line with category trends.

Investment read-through:

  • Revenue stays steady with incremental growth driven by tender cycles and network expansion.
  • Margin improves modestly through manufacturing optimization.
  • Cash flow remains resilient because injectable electrolyte products typically have predictable working-capital patterns relative to more complex specialty drugs.

Downside Case: Procurement repricing or substitute switching

Assumptions:

  • Hospitals face cost pressure and rebid contracts.
  • Competitors offer lower pricing or stronger availability.
  • Substitution increases during supply tightening elsewhere.

Investment read-through:

  • Revenue declines even if total category demand remains stable.
  • Margin compresses first, then volume loss follows.
  • Capital needs rise if the supplier must invest to protect regulatory and continuity performance.

Upside Case: Hospital network expansion and favorable tender outcomes

Assumptions:

  • PRIMSOL wins or expands access in major hospital systems.
  • Supply remains uninterrupted during category-demand spikes.
  • Pricing resets upward within acceptable category parameters.

Investment read-through:

  • Volume growth outpaces category average.
  • Working capital improves if inventory turns accelerate.
  • EBITDA margin expands through volume leverage and yield.

What diligence checklist matters most for PRIMSOL

For an investor evaluating PRIMSOL fundamentals, diligence should prioritize the practical levers below.

1) Sterile manufacturing and compliance

  • FDA/agency inspection outcomes and any warning letters or import alerts tied to the facility producing PRIMSOL (track trend, not one-off events).
  • Batch release timelines and out-of-spec (OOS) history.
  • Sterility assurance performance and deviations that can delay supply.

2) Supply continuity and logistics

  • On-time-in-full (OTIF) metrics for distribution to hospital customers.
  • Manufacturing capacity utilization and backup capacity plans.
  • Recalls and complaint rates tied to container-closure integrity or particulate issues.

3) Commercial execution

  • Hospital group purchasing organization (GPO) contract status and renewal cadence.
  • Portfolio breadth in electrolytes (ability to cross-sell adjacent SKUs reduces churn risk).
  • Pricing history and rebate structures by contract tier.

4) Competitive mapping

  • Identify substitute products with overlapping electrolyte delivery specifications.
  • Track competitor supply performance during prior shortages.
  • Confirm whether hospitals have restrictive product lists that lock in procurement.

How to think about valuation drivers

Because PRIMSOL is procurement-driven, valuation is best linked to:

  • Sustainable gross margin (manufacturing yield and cost structure).
  • Revenue stability (formulary entrenchment and OTIF reliability).
  • Capex intensity (sterile facility maintenance and compliance upgrades).
  • Risk premium for supply disruption or repricing cycles.

In practice, investors should treat PRIMSOL cash flows like a quality-of-supply annuity with periodic procurement renegotiations.


What are the key risks specific to injectable electrolyte brands

  1. Sterile supply interruptions: minor facility events can translate into category-wide stock-outs and contract churn.
  2. Pricing pressure: hospital procurement tends to reset prices on short cycles, compressing margin.
  3. Regulatory maintenance costs: sustained compliance requires continuous QA investment.
  4. Clinical standard-of-care shifts: phosphate replacement strategies can change prescribing patterns.

Key Takeaways

  • PRIMSOL is best analyzed as a hospital-contract continuity product, not as a long-duration IP franchise.
  • Fundamentals hinge on sterile manufacturing performance, supply continuity, and contract pricing, which drive revenue durability and margin.
  • The investment scenario should be modeled through procurement repricing, substitute switching, and operational resilience, not patent-driven exclusivity.
  • Valuation should weight gross margin sustainability, compliance track record, and OTIF reliability as primary downside controls.

FAQs

1) What primarily determines PRIMSOL revenue stability?

Hospital formulary access plus contract continuity and supply reliability. If either slips, volume can fall quickly even when category demand stays flat.

2) What is the biggest controllable factor for an operating company behind PRIMSOL?

Sterile manufacturing continuity: avoiding deviations, ensuring batch release timeliness, and maintaining strong complaint and recall metrics.

3) How does pricing typically evolve for hospital electrolyte injectable brands?

Pricing usually resets via tender and contract rebids, often compressing gross margin unless the supplier has cost and yield advantages.

4) How should investors assess competitive threat to PRIMSOL?

Map substitute electrolyte products with overlapping clinical intent and assess competitors’ availability and pricing strength under hospital contracts, not just product labeling.

5) What diligence items most impact the risk premium?

FDA/agency inspection history at the producing facility, OOS/deviation trend, recall and complaint profile, and OTIF performance for hospital shipments.


References

[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
[2] U.S. Food and Drug Administration. Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/
[3] U.S. FDA. Recalls, Market Withdrawals, & Safety Alerts. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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