List of Excipients in Branded Drug KLOR-CON M

Generic Drugs Containing KLOR-CON M

Company	Ingredient	NDC	Excipient
Upsher-Smith Laboratories LLC	potassium chloride	0245-5317	CELLULOSE, MICROCRYSTALLINE
Upsher-Smith Laboratories LLC	potassium chloride	0245-5317	CROSCARMELLOSE SODIUM
Upsher-Smith Laboratories LLC	potassium chloride	0245-5317	ETHYLCELLULOSE
NCS HealthCare of KY Inc dba Vangard Labs	potassium chloride	0615-7862	CELLULOSE, MICROCRYSTALLINE

What are the Most Frequently-Used Excipients in KLOR-CON M?

# Of NDCs	Excipient
9	CELLULOSE, MICROCRYSTALLINE
9	CROSCARMELLOSE SODIUM
7	ETHYLCELLULOSE
2	ETHYLCELLULOSES

KLOR-CON M Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 6, 2026

KLOR-CON M is an extended-release potassium chloride tablet marketed in 10 mEq and 20 mEq strengths. Its commercial position depends less on active-ingredient exclusivity than on controlled-release performance, gastrointestinal tolerability, tablet manufacturability, supply reliability, and regulatory equivalence. The strongest opportunities are differentiated extended-release platforms, swallowability improvements, excipient optimization, and private-label or regional generic supply.

What is KLOR-CON M and how does its formulation work?

KLOR-CON M contains potassium chloride, an inorganic salt used to prevent or treat hypokalemia. The product is designed to release potassium gradually rather than deliver the full dose immediately. The tablets must be swallowed whole because crushing, chewing, or dissolving can accelerate drug release and increase gastrointestinal exposure.[1]

Product characteristic	KLOR-CON M position
Active ingredient	Potassium chloride
Dosage form	Extended-release tablet
Commercial strengths	10 mEq and 20 mEq
Primary use	Prevention and treatment of potassium depletion
Regulatory category	Small-molecule prescription drug
Key formulation issue	Controlled release of a locally irritating electrolyte
Main competitive risk	Generic potassium chloride extended-release tablets
Biosimilar exposure	None
Primary commercial channels	Retail pharmacy, hospital, long-term care, mail order, specialty distribution

The formulation uses a matrix or coated-tablet approach intended to control potassium release through a combination of insoluble or slowly permeable excipients, binder systems, lubricants, and film-coating materials. The precise composition and process parameters are commercially important because the therapeutic risk is linked to release behavior and gastrointestinal exposure.

What excipients are used in KLOR-CON M?

Public labeling identifies inactive ingredients for the marketed product, but exact excipient quantities and manufacturing parameters generally remain confidential. The label identifies excipient classes that can include cellulose-based fillers, film-forming polymers, binders, lubricants, and coating components.[1]

Potentially relevant excipient categories include:

Excipient category	Likely technical function	Strategic relevance
Microcrystalline cellulose	Diluent, compressibility aid, matrix support	Controls tablet hardness, porosity, and production yield
Ethylcellulose	Release-controlling polymer or coating component	Limits water penetration and potassium diffusion
Hypromellose	Binder, film former, release-control polymer	Adjusts hydration, gel formation, and release rate
Povidone or related binder	Granulation and mechanical strength	Affects granule formation and content uniformity
Magnesium stearate	Lubricant	Improves ejection but can reduce wettability if overused
Talc or mineral coating aid	Anti-tacking and coating processing	Affects coating uniformity
Titanium dioxide or other opacifier	Film-coating appearance and light protection	Supports product identification and coating consistency

The commercial importance of the excipient system is not limited to ingredient identity. Critical variables include polymer viscosity grade, particle size, substitution level, mixing order, granulation endpoint, compaction force, tablet porosity, coating weight gain, and lubricant concentration.

For potassium chloride, these variables can materially alter dissolution. A formulation that is compositionally similar to KLOR-CON M may still fail comparative dissolution or in vivo performance requirements if the manufacturing process produces a different release profile.

Which excipients create the strongest commercial opportunities?

Release-controlling polymers

Ethylcellulose and hypromellose are the most strategically important excipient classes for a KLOR-CON M-type product. Suppliers can differentiate through:

• Lower-viscosity polymer grades that improve processing.
• Controlled particle-size grades that reduce blend segregation.
• Direct-compression grades that eliminate wet granulation.
• Polymer combinations that produce a flatter release curve.
• Co-processing systems that reduce tablet size at the same potassium dose.

The strongest opportunity is a polymer system that maintains controlled release across physiologic pH conditions while reducing tablet mass.

Direct-compression excipients

Potassium chloride has poor flow and compression characteristics relative to many conventional drug substances. A direct-compression platform using co-processed cellulose, silicified microcrystalline cellulose, or specialized granulation aids could reduce manufacturing steps and improve batch consistency.

Potential benefits include:

• Lower manufacturing cost.
• Reduced exposure to moisture.
• Shorter production cycle time.
• Better scale-up performance.
• Lower risk of segregation between potassium chloride and polymer excipients.

The regulatory challenge is that changing granulation or compaction conditions can change dissolution. A cost-saving process has commercial value only if it preserves the established release profile.

Taste-masking and swallowability excipients

Taste is less important after swallowing than for an oral liquid, but potassium chloride products can create an unpleasant salty or irritating sensation if tablets are chewed or damaged. Smaller tablets, smoother coatings, lower-friction surfaces, and improved tablet geometry can reduce handling and swallowing problems.

Commercially attractive approaches include:

• Smaller high-load tablets.
• Film coatings with improved gloss and lower friction.
• Rounded or capsule-shaped tablets.
• Bilayer or multiparticulate systems that permit lower tablet dimensions.
• Sprinkle formulations for patients unable to swallow conventional tablets, subject to separate regulatory development.

Any change that encourages splitting, crushing, or opening the dosage form must be evaluated carefully because it can alter extended release.

What formulations are protected by KLOR-CON M-type intellectual property?

The principal protectable features are formulation and process attributes rather than potassium chloride itself.

Formulation patent opportunities

A competitive patent estate could cover:

1. A specific potassium chloride-to-polymer ratio.
2. A defined ethylcellulose or hypromellose grade.
3. A multilayer tablet architecture.
4. A coating with a specified permeability range.
5. A tablet having a defined dissolution profile.
6. A reduced-size tablet containing a high potassium load.
7. A formulation with reduced gastrointestinal irritation.
8. A composition that remains stable under high humidity.
9. A dosage form that permits administration through a feeding tube.
10. A multiparticulate product with controlled release after sprinkling on soft food.

A strong claim should link composition and performance. Broad claims to potassium chloride with standard cellulose excipients are vulnerable to prior-art and obviousness challenges. Narrow claims tied to an unexpected release, tolerability, stability, or size advantage have greater defensive value.

Manufacturing-process patents

Process protection may cover:

• Dry granulation or roller compaction.
• Controlled moisture granulation.
• Sequential polymer coating.
• Specific compression-force ranges.
• Low-shear blending to prevent segregation.
• Coating weight gain and curing conditions.
• In-line dissolution or near-infrared process controls.

Manufacturing patents can be commercially useful even when formulation claims are weak. A difficult process may also create a practical barrier if competitors need extensive scale-up work to match the reference-product dissolution profile.

How strong is the patent estate for KLOR-CON M?

KLOR-CON M is an older potassium chloride product, so active-ingredient patent exclusivity is not the main barrier to entry. The relevant risks are product-specific patents, Orange Book listings, regulatory exclusivity, and the ability of an ANDA applicant to demonstrate pharmaceutical equivalence and bioequivalence.

Exclusivity factor	Strategic assessment
Active-ingredient patent	Limited relevance for an established potassium chloride product
Formulation patent	Potentially relevant if claims cover release control or tolerability
Method-of-use patent	Usually limited because potassium replacement uses are established
Manufacturing patent	Can protect process know-how and scale-up advantages
New-drug exclusivity	Unlikely to be the principal commercial barrier for an established product
Biosimilar exclusivity	Not applicable
Generic substitution	Primary market threat
Regulatory barrier	Comparative dissolution, bioequivalence, stability, and quality controls

The definitive legal position depends on the current FDA Orange Book listing for the specific KLOR-CON M strength and dosage form. The Orange Book records listed patents and regulatory exclusivity associated with approved products; it does not capture every trade secret, process advantage, or non-listed commercial barrier.[2]

When does KLOR-CON M lose exclusivity?

KLOR-CON M does not face the same exclusivity structure as a recently approved branded drug. Potassium chloride is an established active ingredient, and generic versions can enter through the ANDA pathway if they meet FDA requirements.

The relevant timing questions are:

• Whether any patent is currently listed for the precise KLOR-CON M product.
• Whether an ANDA applicant files a Paragraph IV certification.
• Whether the patent holder brings litigation within the statutory period.
• Whether a 30-month stay applies.
• Whether a settlement restricts or permits an earlier generic launch.
• Whether the applicant qualifies for 180-day first-applicant exclusivity.

A Paragraph IV certification alleges that a listed patent is invalid, unenforceable, or not infringed. If the patent holder files suit within the statutory period, FDA approval may be subject to a stay, subject to the applicable statutory exceptions and litigation outcome.[3]

For an older extended-release electrolyte product, the commercial entry risk can arise even without an aggressive patent challenge. An applicant may pursue a non-infringement position, wait for patent expiry, or develop a formulation that avoids listed claims.

What is the Orange Book status of KLOR-CON M?

The FDA Orange Book should be reviewed by exact product name, strength, dosage form, and application number. The relevant records can include:

• Approved NDA or ANDA number.
• Therapeutic-equivalence rating.
• Listed patents.
• Patent-use codes.
• Regulatory exclusivity.
• Reference listed drug status.

An AB-rated generic potassium chloride extended-release tablet is generally substitutable at the pharmacy level under applicable state law and payer rules. The practical commercial impact of an AB rating is substantial because pharmacy substitution reduces the branded product’s ability to retain volume through physician prescribing alone.

For diligence, the product should be checked against the FDA Orange Book and FDA Drugs@FDA records rather than relying on third-party patent summaries.[2,4]

What patent litigation affects KLOR-CON M?

The litigation risk is likely to center on generic entry, formulation claims, and whether a proposed extended-release product is therapeutically equivalent to the reference product. Key legal issues may include:

• Infringement of formulation claims.
• Obviousness of polymer combinations.
• Written description and enablement.
• Whether dissolution limitations are met.
• Whether the proposed generic uses the claimed process.
• Whether a listed method-of-use patent is relevant to the proposed label.
• Whether a settlement permits an authorized or independent generic launch.

Method-of-use patents are less likely to provide a durable barrier when the indications are broad potassium replacement uses. Formulation and release-profile claims are more commercially relevant.

A settlement can preserve short-term branded revenue while giving the generic applicant a defined launch date. Its value depends on the remaining patent term, expected generic price erosion, authorized-generic rights, and the number of competing ANDA applicants.

Which companies are challenging KLOR-CON M?

The competitive field includes generic manufacturers of potassium chloride extended-release tablets and suppliers capable of producing equivalent matrix or coated-tablet systems. Potential competitors should be assessed through:

• FDA Orange Book therapeutic-equivalence listings.
• FDA product approvals.
• ANDA ownership data.
• Commercial wholesaler listings.
• State substitution databases.
• Patent litigation dockets.
• Product discontinuation notices.

The relevant competitive set includes both branded-generic suppliers and large contract manufacturers. A company does not need a strong consumer brand to pressure KLOR-CON M pricing. Contracted hospital supply and wholesaler substitution can move volume rapidly when the product has an AB-rated alternative.

How does KLOR-CON M compare with competing potassium products?

Product type	Release profile	Main advantage	Main weakness	Commercial opportunity
KLOR-CON M-type ER tablet	Controlled	Familiar dosing and established labeling	Large tablet and swallowing burden	Smaller tablet and improved coating
Immediate-release potassium solution	Rapid or variable	Flexible dose adjustment	Taste, measurement, GI tolerability	Better taste masking and unit-dose packaging
Powder or packet	Variable after reconstitution	Flexible administration	Preparation burden	Ready-to-use or sprinkle formats
Microencapsulated potassium	Controlled	Potentially improved tolerability	More complex manufacturing	Multiparticulate and tube-compatible products
Generic ER tablet	Controlled	Lower price	May have limited differentiation	Private-label and supply contracts

The most defensible commercial differentiation is a measurable patient or operational benefit: reduced tablet burden, better swallowing, improved stability, simpler administration, or lower manufacturing cost.

What generic launch risks exist for KLOR-CON M?

Generic entry can produce rapid price erosion because potassium chloride is a mature therapeutic category with limited prescriber loyalty. The principal risks are:

1. Multiple ANDA approvals arriving within a short period.
2. AB-rated substitution at retail pharmacies.
3. Payer preference for the lowest-cost supplier.
4. Hospital purchasing based on contract price.
5. Shortage-driven switching between manufacturers.
6. Limited clinical differentiation between equivalent products.
7. Retail inventory replacement after wholesaler conversion.

The branded product can defend revenue through supply reliability, authorized-generic strategy, differentiated packaging, and contracts with institutional buyers. A premium price requires a clear benefit beyond the active ingredient.

What licensing deals could create value?

Licensing opportunities are strongest in excipient technology and manufacturing platforms. Potential deal structures include:

• Exclusive rights to a high-load direct-compression excipient system.
• Regional licensing of a multiparticulate potassium chloride formulation.
• Co-development with an excipient supplier.
• Contract manufacturing with technology transfer.
• Authorized-generic commercialization.
• Licensing of a low-humidity or high-throughput coating process.
• Supply agreements with hospitals and long-term-care distributors.

A license should define ownership of formulation improvements, process changes, dissolution specifications, regulatory filings, manufacturing data, and rights to future strengths or dosage forms.

What FDA regulatory pathway applies to an improved KLOR-CON M product?

A conventional generic would normally pursue an ANDA demonstrating pharmaceutical equivalence and bioequivalence to the reference listed drug. A materially different dosage form, route, release mechanism, or administration method may require a 505(b)(2) application rather than a standard ANDA.[3]

Regulatory development should focus on:

• Assay and content uniformity.
• Impurities and degradation products.
• Tablet hardness and friability.
• Release testing across relevant pH conditions.
• Stability under temperature and humidity stress.
• Alcohol-dose-dumping assessment where applicable.
• In vitro-in vivo correlation, if needed.
• Food-effect evaluation.
• Human-factor assessment for new administration instructions.

FDA modified-release guidance treats dissolution as a central quality and equivalence issue. An excipient substitution that appears minor from a composition perspective can require substantial comparative data if it changes release behavior.[5]

What is the revenue exposure from generic competition?

KLOR-CON M revenue is exposed to substitution, channel concentration, and limited switching costs. The economic impact of generic entry is typically determined by:

• Number of approved competitors.
• AB-rating availability.
• Wholesaler stocking decisions.
• Payer formulary preference.
• Product shortage history.
• Branded price premium.
• Hospital versus retail mix.
• Ability to launch an authorized generic.

A defensible forecast should model at least three scenarios:

Scenario	Expected market effect
Single generic entrant	Moderate price pressure; branded retention may remain meaningful
Several AB-rated entrants	Rapid volume and price erosion
Supply disruption among generics	Temporary branded recovery or share stabilization

Key Takeaways

• KLOR-CON M is an extended-release potassium chloride tablet in 10 mEq and 20 mEq strengths.
• The commercial moat is controlled release, manufacturing consistency, supply reliability, and regulatory equivalence rather than active-ingredient exclusivity.
• Cellulose-based polymers, binders, lubricants, and coating materials are central to formulation performance.
• The strongest excipient opportunities involve direct compression, high drug loading, smaller tablets, improved coating, and alternative multiparticulate delivery.
• Formulation and process patents are more relevant than method-of-use patents.
• Biosimilar risk is not applicable because potassium chloride is a small-molecule drug.
• Generic competition is the main commercial threat, with AB-rated products capable of pharmacy substitution.
• A conventional generic generally follows the ANDA pathway; materially different delivery systems may require a 505(b)(2) strategy.
• The FDA Orange Book and Drugs@FDA records are the controlling sources for current patent listings, application status, and therapeutic-equivalence information.
• Licensing value is highest in excipient technology, manufacturing processes, authorized-generic supply, and differentiated dosage forms.

FAQs

Can a new excipient create a patentable KLOR-CON M replacement?

Yes. Patentability is stronger when the excipient produces an unexpected release, stability, tolerability, tablet-size, or manufacturing benefit. A claim limited to substituting one conventional filler for another is less defensible.

Is potassium chloride extended release a good 505(b)(2) opportunity?

It can be if the product provides a materially different dosage form, administration route, release profile, or patient-use benefit. A conventional equivalent tablet is more naturally suited to the ANDA pathway.

Can KLOR-CON M tablets be reformulated into a sprinkle product?

Potentially, but the product must preserve controlled release after administration on soft food or through the intended delivery method. The change could require new bioequivalence, stability, labeling, and human-factors work.

What is the most valuable excipient innovation for potassium chloride tablets?

A high-load, directly compressible excipient and polymer system that reduces tablet size while maintaining dissolution and mechanical strength has the clearest commercial value.

Are potassium chloride formulation patents difficult to enforce?

They can be. Broad claims using established polymers may face obviousness challenges. Claims tied to defined release performance, manufacturing conditions, or unexpected tolerability benefits generally provide a stronger enforcement position.

References

1. DailyMed. (n.d.). KLOR-CON M potassium chloride extended-release tablets: Prescribing information. U.S. National Library of Medicine.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application (ANDA) process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

4. U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/

5. U.S. Food and Drug Administration. (1997). Guidance for industry: Extended release solid oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations. Center for Drug Evaluation and Research.