Last Updated: July 27, 2026

KLOR-CON M10 Drug Patent Profile


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When do Klor-con M10 patents expire, and what generic alternatives are available?

Klor-con M10 is a drug marketed by Upsher Smith Labs and is included in one NDA.

The generic ingredient in KLOR-CON M10 is potassium chloride. There are two hundred and forty drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Klor-con M10

A generic version of KLOR-CON M10 was approved as potassium chloride by ACTAVIS LABS FL INC on April 10th, 2002.

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Questions you can ask:
  • What is the 5 year forecast for KLOR-CON M10?
  • What are the global sales for KLOR-CON M10?
  • What is Average Wholesale Price for KLOR-CON M10?

US Patents and Regulatory Information for KLOR-CON M10

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs KLOR-CON M10 potassium chloride TABLET, EXTENDED RELEASE;ORAL 074726-002 Aug 9, 2000 AB1 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
Last updated: July 22, 2026

KLOR-CON M10 market dynamics and financial trajectory

KLOR-CON M10 (potassium chloride extended-release capsules/tablets; “M10” denotes 10 mEq strength) is a mature, off-patent potassium supplement with a commoditized US market structure. Revenue trajectory is primarily driven by (1) generic availability and price compression, (2) guideline and adherence dynamics for hypokalemia and potassium replacement, (3) payer formulary positioning for oral potassium salts, and (4) competitive substitution among potassium chloride ER products and alternative formulations (mixes, powders, liquid, and different ER matrices). Near-term growth is constrained because the active ingredient is long established and most incremental value is captured through contracting and mix-shift rather than premium pricing.

Below is a market-and-money view of KLOR-CON M10 dynamics, the competitive forces shaping sales, and the practical financial implications for revenue, margins, and future demand.


Is KLOR-CON M10 a high-revenue brand or a commoditized potassium supplement?

Answer: KLOR-CON M10 behaves like a commodity within the oral potassium replacement category. The active ingredient (potassium chloride) is not associated with brand-style monopoly pricing. The commercial profile in practice is that branded “workhorse” oral electrolyte products face sustained generic substitution and contract pricing pressure.

Category economics that cap “brand-style” revenues

Oral potassium replacement products typically compete on:

  • Net price after payer rebates and wholesaler discounting
  • Formulary tier placement (preferred vs non-preferred)
  • Patient tolerability (GI irritation profiles differ by formulation)
  • Dosing convenience (pill burden, ER release profile, titration flexibility)
  • Cost per mEq rather than cost per unit

Because potassium chloride is widely generic, incremental revenue growth usually comes from supply chain reliability, channel penetration, and formulary wins, not from patent exclusivity or differentiated clinical value.


What market dynamics drive demand for KLOR-CON M10 in hypokalemia treatment and prevention?

Answer: Demand is linked to chronic and recurrent hypokalemia risk drivers that sustain potassium replacement across populations.

Primary demand drivers

  1. Diuretic use
    • Loop and thiazide diuretics increase potassium loss, driving ongoing potassium supplementation in a subset of treated patients.
  2. Cardiometabolic comorbidity
    • Heart failure, hypertension, and metabolic syndrome increase electrolyte monitoring and replacement needs.
  3. Renal and medication interplay
    • Patients on regimens that affect potassium handling (including some antihypertensives and other agents) increase the frequency of potassium monitoring, and replacement when levels fall.
  4. Laboratory monitoring cycles
    • CKD and chronic cardiovascular management create steady laboratory-driven initiation and adjustments.

Substitution pressure within oral potassium salts

Even if a prescriber prefers potassium chloride ER, substitution happens at multiple levels:

  • Other potassium chloride ER products (different manufacturers and dosage forms)
  • Alternative potassium salts (less common but clinically relevant in certain tolerability contexts)
  • Different dosing architectures (powders/liquids vs solid ER)

How do generic pricing and formulary contracting affect KLOR-CON M10 revenue?

Answer: Net sales typically compress toward generic-equivalent pricing levels, with branded revenue depending on contracting outcomes and patient/channel retention.

What to expect in a commoditized environment

  • Mid-single-digit to low single-digit volume changes often matter more than price.
  • Annual net price declines tend to occur when new generics gain traction or when payers switch preferred products.
  • Wholesaler and PBM contracting cadence can create step-downs in net revenue.

Where KLOR-CON M10 still can matter

Even with generics available, some branded or “branded generic-adjacent” products can maintain share when they:

  • Win preferred tiers for oral potassium chloride ER
  • Have lower substitution rates due to packaging, dosing familiarity, or pharmacy workflows
  • Maintain reliable supply during generic churn

What competitive landscape includes KLOR-CON M10 and oral potassium chloride ER products?

Answer: The competitive set is mainly other oral potassium chloride ER SKUs (multiple manufacturers) competing on net price and formulary positioning.

Competitive “buckets” for prescribers and payers

  1. Potassium chloride ER capsules/tablets (same salt, different ER matrix)
  2. Potassium chloride immediate-release (less common for long-term ER use due to GI tolerability)
  3. Liquid and powder potassium chloride preparations
  4. Alternative potassium salts (market exists but is smaller and more dependent on tolerability or formulary rules)

Why ER formulations are sticky but still substitute-able

ER products are favored for adherence and GI tolerability. However, within ER, pharmacy substitution still occurs unless a product is locked by payer rules.


When does KLOR-CON M10 face patent and exclusivity loss risks, and are they relevant to near-term commercialization?

Answer: For KLOR-CON M10, commercialization is driven more by generic market structure than by active patent exclusivity. For mature potassium chloride products, “near-term exclusivity risk” is usually low because relevant exclusivities for original brand launches are long expired.

Practical exclusivity implications for revenue

  • Revenue risk is structural: competition exists now and continues through contract cycles.
  • Entry timing depends on generic filings, approvals, and launch readiness, not on brand exclusivity events.

What FDA status and Orange Book listing patterns apply to KLOR-CON M10?

Answer: KLOR-CON M10’s FDA regulatory reality typically reflects an ANDA-accessible, established drug substance class with multiple entries for potassium chloride ER.

What matters commercially in FDA listings

Even without premium exclusivity, FDA and Orange Book status influences:

  • Number of authorized generic manufacturers
  • Availability stability
  • Switching behavior based on what is in stock and what pharmacies prefer under contracts

How does KLOR-CON M10 compare with other oral potassium chloride ER strengths and formulations?

Answer: ER strength variants compete within a dosing ladder. “M10” competes with other mEq doses (e.g., 8 mEq, 10 mEq, 15 mEq, 20 mEq depending on the product line) and with different ER product architectures.

What affects share between ER strengths

  • Prescriber dosing habits tied to titration and patient tolerance
  • Pill burden tradeoffs: fewer mEq per pill can shift demand
  • Formulary equivalents: payers often list preferred ER strengths and mandate step therapy or substitution

What generic entry risks exist for KLOR-CON M10?

Answer: The principal generic entry risk is incremental market-share erosion when additional potassium chloride ER SKUs launch or when a competitor becomes preferred on a major formulary.

Generic launch risk pathways

  1. New ANDA entrants increase authorized supply
  2. Manufacturing capacity shifts pricing
  3. PBM formularies re-rank preferred status

What would cause revenue shocks

  • Sudden preferred-tier change on a large payer
  • Channel supply disruptions that temporarily force substitutions
  • Broad net price resets after competitive tendering

How do wholesaler inventory cycles and supply reliability affect KLOR-CON M10 sales performance?

Answer: In mature oral generics and commodity medicines, sales can be volatile due to inventory management rather than demand changes.

Typical commercial mechanics

  • Short-term stockouts can transfer prescriptions to substitutes
  • Restocks can temporarily boost sales volume but do not eliminate share loss
  • Manufacturer lead time reliability influences which SKU pharmacies reorder

What is KLOR-CON M10’s expected margin profile and financial trajectory drivers?

Answer: Margin profile typically trends downward as net prices compress and competition increases. Financial trajectory is dominated by net price, contracting, and mix rather than premium differentiation.

Revenue decomposition framework (how executives should view the P&L)

  • Unit volume: driven by patient counts and adherence plus substitution dynamics
  • Net price: driven by PBM rebates, payer contracts, and competitive tender pressure
  • Mix: strength and formulation mix across the broader potassium chloride ER portfolio can move gross-to-net differently

In a commodity category, long-run performance often mirrors the category, with brand share drifting downward unless there are packaging or formulary advantages.


What are the revenue exposure scenarios for KLOR-CON M10 across the next 3–5 years?

Answer: Revenue exposure is mostly downside from incremental generic preference shifts and price resets, offset partially by persistent hypokalemia replacement demand.

Scenario map

  • Base case (most likely): modest volume stability or small declines; net price continues to compress slowly; profitability remains constrained.
  • Downside: payer tier downgrades plus competition for the same ER strength causes share loss; net revenue declines faster.
  • Upside (limited): retention of preferred status on key formularies and improved supply reliability stabilizes volume; net price stabilizes with contract renewals.

Key Takeaways

  • KLOR-CON M10 functions as a commoditized oral potassium chloride ER product where net contracting and generic substitution drive revenue more than clinical differentiation.
  • Demand persists due to diuretic-related hypokalemia risk and routine laboratory monitoring, but price compression and formulary switching cap long-run brand-like growth.
  • Financial trajectory is primarily shaped by gross-to-net dynamics, payer preferred-tier changes, and availability/supply reliability rather than exclusivity events.
  • The largest commercial risk is incremental share erosion when additional potassium chloride ER products become preferred or when PBMs reset preferred lists.

FAQs

  1. What patient populations most consistently drive sales of oral potassium chloride ER products like KLOR-CON M10?
    Patients at risk of hypokalemia, especially those on chronic diuretic therapy and those requiring ongoing electrolyte monitoring.

  2. Do ER formulations materially change switching behavior versus immediate-release potassium chloride?
    ER products improve tolerability/adherence, but pharmacies still substitute within ER product classes if payer and contract rules allow.

  3. How do PBM formulary tier moves typically impact commodity drug net revenue?
    Tier downgrades tend to reduce dispensing share and can cause net price resets at contract renewal.

  4. What supply-chain events most often create short-term KLOR-CON M10 sales swings?
    Stockouts, manufacturing capacity constraints, and restock timing that shift prescriptions toward available alternatives.

  5. Is KLOR-CON M10 competing against other potassium salts or mostly against potassium chloride ER generics?
    Mostly against other potassium chloride ER products of different manufacturers and strengths, with some competition from alternative formulations based on tolerability and formulary rules.


References (APA)

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA Orange Book database).

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