Last Updated: August 10, 2026

PASKALIUM Drug Patent Profile


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

Paskalium is a drug marketed by Glenwood and is included in one NDA.

The generic ingredient in PASKALIUM is potassium aminosalicylate. There are two hundred and forty drug master file entries for this compound. Additional details are available on the potassium aminosalicylate profile page.

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Summary for PASKALIUM
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 133
Patent Applications: 6
DailyMed Link:PASKALIUM at DailyMed

US Patents and Regulatory Information for PASKALIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenwood PASKALIUM potassium aminosalicylate CAPSULE;ORAL 009395-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glenwood PASKALIUM potassium aminosalicylate TABLET;ORAL 009395-003 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 12, 2026

PASKALIUM (potassium bicarbonate and potassium chloride) Market Dynamics and Financial Trajectory: Sales, Pricing, Uptake, and Competitive Risk

PASKALIUM is a potassium-based electrolyte product positioned for correction of potassium loss and related conditions. Public market and financial trajectory visibility depends on jurisdictional approvals, payer coverage, and whether the product is sold as an authorized brand or dispensed through hospital/wholesale channels. Without reliable, citable public data on (1) branded sales, (2) net price and reimbursement, and (3) launch timing by country and formulation, a complete market-dynamics and revenue trajectory analysis cannot be produced to a litigation- or investment-grade standard.

What is PASKALIUM and what product form drives prescribing and hospital uptake?

PASKALIUM is marketed as a potassium replenishment therapy using potassium salts. Market adoption typically hinges on three commercial levers: formulation convenience (oral vs. other dosage forms), dosing flexibility, and compatibility with hospital electrolytes workflows.

Dosage form and administration: what matters commercially

  • Route and administration: products with ease of dosing and stable preparation are adopted faster in acute care settings.
  • Electrolyte substitution fit: alignment with standard potassium replacement protocols affects formulary decisions.
  • Storage and handling: logistics and shelf-life influence hospital contracting.

Indication and guideline alignment

Adoption accelerates when a product:

  • matches guideline-based potassium targets for hypokalemia management,
  • reduces need for intensive monitoring,
  • fits into emergency department and inpatient order sets.

How does pricing and reimbursement typically affect PASKALIUM sales trajectory?

A potassium replenishment brand’s sales curve is usually shaped by:

  • wholesale acquisition cost (WAC) and contract price dispersion across institutional accounts,
  • payer reimbursement classification (brand drug vs. pharmacy benefit vs. medical benefit),
  • therapeutic interchangeability with generics (which compresses margins after coverage is granted).

Commercial pattern for electrolyte brands

  • Early phase: higher net price relative to later periods when contracting and therapeutic substitution take hold.
  • Mid phase: volume growth concentrates in large hospital systems that standardize on a formulary electrolyte product.
  • Late phase: margin pressure if lower-cost generics or alternative potassium salt formulations gain preferred status.

What market dynamics influence competitive share for potassium replenishment products?

PASKALIUM competes in a basket of potassium replacement options that may include:

  • potassium chloride generic tablets and solutions,
  • alternative potassium salts (where available),
  • multi-electrolyte infusions and bundled electrolyte products.

Key competitive drivers

  • Formulary inclusion at hospital group level.
  • Contract pharmacy and GPO pricing.
  • Clinician familiarity and substitution policies.
  • Supply continuity and batch availability.

Substitution risk

For electrolyte therapies, therapeutic substitution is common once payers and institutions consider multiple potassium products clinically interchangeable. This dynamic usually limits sustained unit-price expansion unless there is clear formulation or outcome differentiation.

When does PASKALIUM face exclusivity loss or generic entry risk?

A structured exclusivity and patent-loss timeline requires Orange Book listings, patent family data, and jurisdictional regulatory exclusivity grants. Without verifiable patent numbers, filing dates, and approval dates tied to specific countries, a credible “loss of exclusivity” timeline cannot be computed.

What patents protect PASKALIUM and how strong is the patent estate?

Patent-strength assessment requires:

  • confirmed active ingredient and formulation scope,
  • listed patents by jurisdiction,
  • remaining term by claim set,
  • any litigation that narrows enforcement.

No patent estate dataset for PASKALIUM is provided in the prompt, and a defensible estate analysis cannot be created without citable, drug-specific patent identifiers.

How do FDA pathway status and Orange Book listings affect PASKALIUM commercialization?

Orange Book status and FDA pathway determine:

  • whether PASKALIUM is tied to NDA exclusivity,
  • whether listed patents block generic approval,
  • whether the product is eligible for 505(b)(2) or other pathways that alter exclusivity and method-of-use risk.

No FDA label, NDA/BLA number, or Orange Book listing is provided for PASKALIUM, preventing a factual status mapping.

What patent litigation or Paragraph IV challenges affect PASKALIUM market access?

Paragraph IV litigation timing and outcome materially affect:

  • generic launch date certainty,
  • settlement terms and “at-risk” launch posture,
  • revenue volatility for the reference product.

No PASKALIUM-specific litigation docket or settlement records are provided, so litigation-driven market dynamics cannot be quantified.

Which companies are competing with PASKALIUM and how does PASKALIUM compare on efficacy and dosing?

A competitive landscape needs:

  • named branded comparators in the same route and strength,
  • generic competitors by formulation and dosage,
  • payer preference signals (tender winners, formulary tier placement),
  • substitution policies.

Without a country-specific competitor list and dosage mapping, a defensible comparison cannot be compiled.

What commercial metrics best track the financial trajectory of PASKALIUM?

For electrolyte and replacement products, financial trajectory is typically tracked via:

  • units dispensed/sold at retail or hospital level,
  • net revenue vs. list price (rebates, contracts),
  • gross margin (formulation cost and supply terms),
  • share of hospital formularies,
  • tender awards and seasonal usage.

To produce a trajectory, these must be linked to consistent time-series data.

Revenue exposure scenarios: what happens to PASKALIUM if generics enter or price cuts accelerate?

A robust exposure model needs:

  • baseline revenues by jurisdiction,
  • historic contract pricing cadence,
  • generic penetration milestones,
  • elasticity estimates by setting (hospital vs. retail).

No such inputs are present, so scenario modeling cannot be executed to a decision-grade level.

Key Takeaways

  • PASKALIUM’s market and financial trajectory is highly dependent on country-specific regulatory status, formulary inclusion, contract pricing, and generic substitution risk.
  • A complete exclusivity, patent, litigation, and revenue trajectory analysis requires drug-specific regulatory identifiers and citable sales/price data. Those inputs are not available in the provided material.
  • For potassium replenishment products, sustained pricing power is typically limited by therapeutic interchangeability once lower-cost alternatives become preferred.

FAQs

  1. How quickly do hospital formularies adopt new potassium replenishment brands?
  2. What reimbursement designations most affect net price for electrolyte replacement drugs?
  3. Which factors drive tender-based switching in inpatient electrolytes procurement?
  4. How do patent listings in Orange Book influence generic launch timing for electrolyte products?
  5. What indicators signal impending generic substitution for potassium salts?

References

No sources were provided in the prompt, and no PASKALIUM-specific regulatory, patent, sales, or payer documentation is available in the provided material to cite.

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