When will the KLOR-CON M15 patents expire, and when will generic KLOR-CON M15 be available?

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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
Upsher Smith Labs	KLOR-CON M15	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	074726-003	Jun 6, 2003	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 14, 2026

KLOR-CON M15 (potassium chloride extended-release) investment scenario and patent/regulatory fundamentals analysis

KLOR-CON M15 is an FDA-approved potassium chloride extended-release (ER) solid oral electrolyte replacement product (active ingredient: potassium chloride). The investment case is driven by (1) low patent intensity typical of commodity electrolyte salts, (2) generic price compression risk, and (3) channel and supply strength rather than new-drug differentiation. For patent-backed exclusivity, formulation and method-of-use coverage is usually the only plausible residual protection for branded ER potassium chloride, but commercial pull-through is typically constrained by established generic competition.

Commercial anchor assumptions used for the scenario model

Product type: potassium chloride ER tablet (mix of strengths and modified-release platform variants across the KLOR-CON franchise).
Typical market economics for electrolyte ER: high generic penetration, thin margins, and frequent wholesaler stocking of low-cost SKUs.
Key revenue sensitivities: ingredient cost pass-through, ER formulation supply capacity (tableting/coat process yields), and pharmacy benefit manager (PBM) contracting.

What matters most for investors: KLOR-CON M15 should be treated like a “distribution and execution” asset unless a verifiable, enforceable exclusivity barrier exists in Orange Book and current litigation records for the exact M15 SKU (strength, release profile, and listed patents).

What patents protect KLOR-CON M15 (potassium chloride ER M15) and how strong is the patent estate?

A complete strength assessment requires Orange Book patent listings tied to the exact KLOR-CON M15 NDA/strength and the corresponding unexpired claims (drug product vs. method-of-use vs. manufacturing). With potassium chloride, branded estates often have limited incremental IP after initial approvals, and generics commonly clear on chemistry-identical formulations.

Featured-snippet answer: For commodity electrolyte ER salts, the protection pattern is typically weak and late-stage dependent on formulation or packaging-specific claims, with generic entry risk high once any Orange Book barriers expire or are weakened through settlements or court outcomes.

Patent estate construction for ER potassium chloride brands

In practice, investors evaluate three IP buckets:

Drug substance/route patents (often long expired for potassium chloride salts).
Drug product formulation patents
- matrix/coat composition and release-rate controls
- excipient systems that govern ER dissolution
- compression, coating, and granulation process variables that affect dissolution profile
Method-of-use patents
- typically not common for potassium chloride unless tied to specific clinical claims (e.g., potassium maintenance regimens)

Investment implication: unless KLOR-CON M15 has active, listed Orange Book drug product patents with remaining enforceable life, the valuation should discount heavily for generic competition.

What is the Orange Book status of KLOR-CON M15 and which patents are listed for the exact M15 strength?

Orange Book status determines whether a branded SKU still has regulatory exclusivity protection (listed patents) and whether it faces paragraph IV certification risk.

Featured-snippet answer: The existence and expiration timing of Orange Book patents for the exact KLOR-CON M15 strength is the gating variable for investor underwriting. If the Orange Book list is empty or fully expired, the SKU functions like a de facto generic product.

How to underwrite Orange Book listings for this SKU

For KLOR-CON M15, the underwriting checklist is:

NDA number and label strength for M15
Orange Book “drug product” vs “drug substance” vs “method of use” classifications
Patent expiration dates and whether any have terminal disclaimers
Provisions for pediatric exclusivity or Hatch-Waxman exclusivity periods, if any
Whether any patents have been the subject of ANDA paragraph IV notices

Fundamentals lens: Orange Book listings map directly to probability-weighted generic entry dates and expected erosion of branded ASP.

When does KLOR-CON M15 lose exclusivity, and what are the key expiration dates that drive generic launch timing?

The generic launch timeline for an ER potassium chloride brand is generally determined by:

patent expiration of the last listed Orange Book patent (with respect to the specific dosage form)
any regulatory exclusivity (if tied to the NDA)
any litigation stay outcomes

Featured-snippet answer: For potassium chloride ER brands, exclusivity loss is usually fast and deterministic once the last listed patent or exclusivity period ends. That makes date accuracy critical to scenario modeling.

Investment scenario mechanics

Investors typically build three timing scenarios:

Base case: last Orange Book patent expires on schedule, no successful late litigation defense
Bull case: delayed generic entry from a favorable court ruling, settlement, or injunction
Bear case: paragraph IV triggers earlier settlements or a pre-expiry commercial switch via authorized generics or launch-at-risk tactics

Fundamentals: Without confirmed, active KLOR-CON M15 listings, the safest underwriting baseline is near-term erosion from generics.

Which companies are challenging KLOR-CON M15 with ANDA paragraph IV certifications and what does that mean for launch-at-risk risk?

Paragraph IV challenges signal that an ANDA applicant considers at least one Orange Book patent invalid, unenforceable, or not infringed.

Featured-snippet answer: If there is any active paragraph IV litigation around KLOR-CON M15 patents, the investment thesis shifts from “generic pricing pressure” to “event-driven litigation and settlement outcome.”

What investors track

ANDA filers and their likely launch dates
whether the case is in Delaware (often), D.C., or another district
whether a 30-month stay applies and for how long it persists
settlement terms (skin-in-the-game affects whether challengers launch immediately at expiry)

What generic entry risks exist for KLOR-CON M15 and how would pricing and market share typically move?

For electrolyte ER tablets, generic entrants compete mainly on:

price
contract terms with wholesalers and PBMs
supply reliability

Featured-snippet answer: If KLOR-CON M15’s Orange Book barriers are expired or thin, generic entry tends to cause swift ASP compression and share transfer, usually within 6 to 18 months of launch.

Erosion model for branded ER electrolytes (typical shape)

Year 0 launch: branded loses incremental share at the margin as payers open formularies to generics
Year 1: cumulative prescriptions shift toward cheapest contracted SKU
Year 2: pricing stabilizes at a lower band tied to generic competition intensity

Investment implication: A branded investor should value the asset as a shrinking cashflow stream unless there is enforceable exclusivity.

How does KLOR-CON M15 compare with competing potassium chloride ER products in patent posture and commercial differentiation?

Investors benchmark against competing ER potassium chloride brands and multisource generics on three axes:

Release profile and dissolution performance
Patent life and Orange Book listings
Payer contracting strength and wholesaler velocity

Featured-snippet answer: In potassium chloride ER, differentiation is usually limited once generics are present; brand advantage is typically contractual and supply-driven rather than clinical superiority.

Competitive set framing

Relevant comparators typically include other KLOR-CON strengths (M10, M20), other ER potassium chloride brands, and approved generics that match release characteristics under FDA bioequivalence expectations.

What formulations are protected by KLOR-CON M15 patents, and are they product-line specific (M15 vs other KLOR-CON strengths)?

For ER tablets, formulation IP can be:

strength-specific (matrix composition tuned to M15 dose load)
platform-specific (same release technology applied across strengths)

Featured-snippet answer: If the only remaining patents are strength-specific to M15, generics may enter other strengths sooner while M15 lags. If the patents are platform-wide, entry delays for the whole KLOR-CON ER family.

Underwriting point for investors

A strength-specific claim set increases the payoff asymmetry if only one SKU is blocked.
A platform-wide claim set increases the value of the broader franchise but also concentrates litigation risk.

What method-of-use or dosing patents could apply to KLOR-CON M15?

Method-of-use IP for electrolyte supplementation is less common than formulation IP but can exist for narrow clinical claims.

Featured-snippet answer: If method-of-use patents exist and remain enforceable, they can slow generic substitution when payers require label-aligned claims.

Likely practical effect

Even when method-of-use patents exist, generic products typically carry the same potassium chloride ER indications, and infringement arguments may turn on label interpretation and prescribing behavior rather than on ability to market.

What patent litigation affects KLOR-CON M15, and what have courts decided in similar potassium chloride ER disputes?

Litigation is the pivot for late exclusivity survival: it can end in a dismissal, loss on validity, a settlement with delayed entry, or a court-enforced injunction.

Featured-snippet answer: For commodity electrolyte salts, litigation is most likely to end in early settlements or rapid generic entry once patents expire, unless there is a strong formulation claim that survives validity challenges.

How to map litigation outcomes to investment decisions

Investors translate litigation to:

probability of generic launch at a specific date
potential authorized generic or settlement entry calendar
expected time horizon for branded revenue erosion

What settlement agreements exist for KLOR-CON M15 and how do they control generic launch dates?

Settlements typically include:

dismissal of claims
licensing terms or covenant-not-to-sue
agreed “no-launch” periods
sometimes revenue or supply arrangements

Featured-snippet answer: In ER potassium chloride, settlements typically extend the commercial lockout only modestly versus hard expiration, but the exact terms control the near-term cashflow path.

Investment modeling approach

Base case: settlement leads to an agreed launch date shortly after expiration
Bull case: settlement extends beyond the expected expiration through additional “carve-outs” or alternative switching dates
Bear case: settlement allows earlier authorized generic shipments that accelerate revenue loss

What is the FDA regulatory status of KLOR-CON M15, including bioequivalence and substitution constraints?

KLOR-CON M15 is an approved NDA product. FDA substitution constraints are usually administrative:

FDA-approved generics that meet bioequivalence standards can generally be substituted.
Formulary controls are driven by payer contracting and pharmacy benefit design.

Featured-snippet answer: Regulatory constraints after approval typically do not stop substitution unless patent enforcement or exclusivity blocks entry.

Key regulatory fundamentals investors watch

availability of FDA-approved generic equivalents
whether any “AB-rated” generics exist for the exact strength and dosage form
whether any label changes complicate therapeutic equivalence decisions (rare for potassium chloride)

Commercial revenue exposure for KLOR-CON M15: what drives demand and margin durability?

Demand for potassium chloride ER is linked to:

patient populations with hypokalemia risk or chronic electrolyte maintenance needs
prescribing patterns for ER formulations that reduce GI side effects relative to immediate-release potassium

Margin durability is driven by:

branded vs generic cost positioning
contracting terms with PBMs and large accounts
supply continuity and manufacturing yield

Featured-snippet answer: For an ER electrolyte tablet brand, revenue durability correlates more with payer placement and supply than with new IP creation.

Practical margin and volume drivers

Ingredient cost volatility (potassium chloride commodity price)
Manufacturing costs and scale utilization
wholesaler buy-downs and rebating structures
competitive switching triggered by PBM formulary updates

Which business strategies improve the investment case for a KLOR-CON M15 brand holder or licensee?

Given the asset profile of electrolyte ER products, best-fit strategies typically include:

Contracting and channel lock-in with targeted rebates for formulary tier placement.
Supply reliability to avoid backorders that cause permanent prescriber switching.
Defense of remaining IP only if Orange Book shows active, enforceable patents tied to M15.
SKU bundling across strengths if platform patents exist and if litigation covers the franchise.

Featured-snippet answer: If Orange Book barriers are weak, the viable investment levers are commercial execution and cost control rather than reliance on patent tailwinds.

Investor scenario table: base, bull, bear paths for KLOR-CON M15

Scenario	Core premise	Expected generic entry timing	Branded revenue trajectory	Key underwriting risk
Bear	Orange Book barriers are minimal/expired and generics AB-rate quickly	Near-term to ~12 months post “barrier gone”	Sharp ASP compression, share loss	Unexpected payer switch acceleration
Base	At least one enforceable listed patent delays entry modestly	~12–24 months	Gradual erosion with continued brand resilience	Litigation or settlement changes launch calendar
Bull	Strong, enforceable formulation or method-of-use coverage blocks entry or extends settlement	Beyond expected date	Slower erosion, higher cashflow duration	Patent validity outcomes or design-around by generics

Critical input for scenario selection: exact Orange Book last expiration and any current paragraph IV/litigation/settlement status for the M15 strength.

Key Takeaways

KLOR-CON M15 is a potassium chloride ER tablet asset with fundamentals that typically resemble a commodity defense model: payer contracting, supply execution, and cost control matter more than clinical differentiation once generics enter.
The investment question turns on whether the exact KLOR-CON M15 strength has active, enforceable Orange Book listed patents and whether any current paragraph IV challenges or settlements extend the cashflow window.
If Orange Book barriers are absent or expired, generic entry risk is high and value should be underwritten to rapid branded ASP compression.
If there is meaningful remaining patent life tied to M15’s ER formulation or dosing platform, the thesis shifts to event-driven risk: litigation, settlement terms, and the resulting generic launch calendar.

FAQs

Does KLOR-CON M15 have Orange Book listed patents that can delay generic entry?
How fast do potassium chloride ER branded tablets lose market share after generic launch?
What is the commercial impact of authorized generics versus standard ANDA launches for ER potassium chloride?
Do formulation or manufacturing process patents matter more than method-of-use patents for electrolyte ER products?
What payer levers most affect continued brand uptake for low-innovation commodity therapeutics like potassium chloride ER?

References (APA)

FDA. Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

KLOR-CON M15 Drug Patent Profile

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DrugPatentWatch^® Litigation and Generic Entry Outlook for Klor-con M15

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