List of Excipients in Branded Drug POTASSIUM CITRATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Upsher-Smith Laboratories LLC	POTASSIUM CITRATE	potassium citrate	0245-0070	CARNAUBA WAX
Upsher-Smith Laboratories LLC	POTASSIUM CITRATE	potassium citrate	0245-0070	MAGNESIUM STEARATE
Biocomp Pharma Inc	POTASSIUM CITRATE	potassium citrate	44523-415	CARNAUBA WAX
Biocomp Pharma Inc	POTASSIUM CITRATE	potassium citrate	44523-415	MAGNESIUM STEARATE
Bryant Ranch Prepack	POTASSIUM CITRATE	potassium citrate	72162-2187	CARNAUBA WAX
Bryant Ranch Prepack	POTASSIUM CITRATE	potassium citrate	72162-2187	MAGNESIUM STEARATE

Generic Drugs Containing POTASSIUM CITRATE

Company	Ingredient	NDC	Excipient
Actavis Pharma Inc	potassium citrate	0591-2682	CARNAUBA WAX
Actavis Pharma Inc	potassium citrate	0591-2682	MAGNESIUM STEARATE
Rising Pharma Holdings Inc	potassium citrate	16571-864	CARNAUBA WAX
Rising Pharma Holdings Inc	potassium citrate	16571-864	MAGNESIUM STEARATE
Rising Pharma Holdings Inc	potassium citrate	16571-864	STEARIC ACID
Camber Pharmaceuticals Inc	potassium citrate	31722-129	CARNAUBA WAX

What are the Most Frequently-Used Excipients in POTASSIUM CITRATE?

# Of NDCs	Excipient
34	CARNAUBA WAX
34	MAGNESIUM STEARATE
8	SILICON DIOXIDE
9	STEARIC ACID

Potassium Citrate Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 9, 2026

Potassium citrate is a mature, genericized urinary alkalinizer with limited active-ingredient patent protection. Commercial differentiation depends on dosage-form performance, gastrointestinal tolerability, adherence, palatability, manufacturing cost, and regulatory execution. The strongest opportunities are extended-release tablets, low-volume oral liquids, pediatric and veterinary formats, and combination products for recurrent nephrolithiasis and hypocitraturia.

What is the commercial and regulatory status of potassium citrate?

Potassium citrate is the potassium salt of citric acid. It is used primarily to raise urinary citrate and urinary pH in patients with hypocitraturia, uric acid lithiasis, and selected renal tubular disorders. The drug is administered orally as extended-release tablets, oral solutions, powders, and liquid concentrates.

The principal U.S. branded product is Urocit-K, marketed by Mission Pharmacal. Generic potassium citrate extended-release tablets and oral solutions also compete in the market. The product is generally regulated as a prescription drug when used in therapeutic strengths and indications.

Attribute	Commercial position
Active ingredient	Potassium citrate, commonly potassium citrate monohydrate
Main therapeutic use	Hypocitraturia, uric acid kidney stones, selected renal tubular conditions
Common dosage forms	Extended-release tablets, oral solution, powder or crystal packets
Primary route	Oral
Reference brand	Urocit-K
Competitive structure	Branded product plus generic manufacturers
Main patient issue	High pill burden and gastrointestinal intolerance
Main formulation challenge	Delivering high potassium loads without dose dumping or poor taste
Key regulatory pathway	ANDA for generic products; 505(b)(2) may be relevant for materially differentiated dosage forms
Biosimilar exposure	None; potassium citrate is a small-molecule salt

The reference labeling identifies potassium citrate extended-release tablets as a controlled-release product intended to reduce gastrointestinal exposure to concentrated potassium loads. Tablets must generally be swallowed whole rather than crushed or chewed because disruption can alter release characteristics.[1]

What excipients are used in potassium citrate extended-release tablets?

Potassium citrate tablets require excipients that can accommodate a high active load while controlling water penetration, dissolution, mechanical strength, and gastric tolerability.

Public labeling for Urocit-K identifies a matrix-style formulation containing inactive ingredients such as wax, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, croscarmellose sodium, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide, depending on strength and presentation.[1,2]

Functional role of the principal excipients

Excipient category	Typical examples	Function in potassium citrate tablets
Matrix former	Wax or hydrophobic lipid	Slows liquid penetration and potassium citrate release
Diluent or compression aid	Microcrystalline cellulose	Supports tablet strength and processability
Glidant	Colloidal silicon dioxide	Improves powder flow during high-load compression
Lubricant	Magnesium stearate	Reduces sticking and ejection force
Disintegrant	Croscarmellose sodium	Controls structural breakup where required
Film former	Polyvinyl alcohol	Provides coating structure and surface protection
Plasticizer or coating aid	Polyethylene glycol	Improves coating flexibility
Anti-adherent or coating component	Talc	Reduces tack and improves coating performance
Opacifier or colorant	Titanium dioxide or alternative pigment	Provides appearance and light protection

The formulation objective is not simply slower dissolution. Excessive hydrophobicity can delay release beyond the intended profile, while insufficient matrix control can cause rapid potassium release and gastrointestinal irritation. High-dose potassium salts also create compression and tablet-size constraints.

What excipient attributes matter most?

The highest-value excipient attributes are:

1. Controlled release across variable gastrointestinal pH.
2. High loading capacity with acceptable tablet hardness.
3. Low hygroscopicity and stable moisture performance.
4. Low interaction with potassium citrate during storage.
5. Reliable dissolution after long-term aging.
6. Low risk of sticking, picking, and capping during compression.
7. Compatibility with film coating and common packaging.
8. Acceptable global regulatory status.

A formulation change should be assessed against the complete dissolution profile, not only a single release time point. Potassium citrate products may be sensitive to tablet porosity, wax distribution, compression force, coating weight, and storage humidity.

What excipient strategies can improve potassium citrate products?

The most commercially relevant strategies fall into four categories: better release control, smaller dosage units, improved palatability, and easier administration.

Hydrophobic matrix optimization

Wax-based matrices are established for extended-release potassium citrate. Commercial opportunities exist in optimizing the ratio and distribution of wax, lipid, polymer, and pore-forming components.

Potential benefits include:

• More consistent release across manufacturing lots.
• Lower tablet weight for the same dose.
• Reduced risk of rapid potassium release.
• Better performance after exposure to fed and fasted conditions.
• Improved robustness against compression variation.

A formulation patent could protect a defined matrix composition, excipient ratio, manufacturing sequence, dissolution profile, or food-effect performance even if the active ingredient itself is unprotected.

Polymer-based extended release

Hydrophilic polymers such as hypromellose can provide controlled hydration and gel formation. A polymer matrix may reduce reliance on wax and support more predictable scale-up, but high potassium citrate loading can make the tablet large and may weaken mechanical integrity.

The commercial value depends on whether a polymer system can achieve equivalent or better release performance with:

• Lower tablet mass.
• Reduced manufacturing complexity.
• Better robustness at different compression forces.
• Stable release after humidity exposure.
• Lower excipient cost.

Multiparticulate and pellet systems

Pellets, granules, or mini-tablets can distribute the potassium citrate dose across multiple release units. Multiparticulates may reduce the risk that one damaged tablet releases the entire dose. They can also support sprinkle formulations, sachets, and capsules.

The barriers are higher manufacturing cost, more complex dose uniformity testing, and the need to demonstrate that the multiparticulate system is clinically and biopharmaceutically appropriate.

Taste-masked oral liquids and powders

Potassium citrate has a salty, alkaline taste. Liquid and powder products require a palatability strategy that does not compromise chemical stability or potassium delivery.

Potential excipient tools include:

• Sweeteners such as sucralose or acesulfame potassium.
• Flavor systems designed for mineral and alkaline notes.
• Acidulants or buffers that moderate taste without defeating urinary alkalinization.
• Viscosity modifiers for suspension uniformity.
• Chelating or antioxidant systems where justified by stability data.
• Unit-dose packaging that limits exposure to moisture.

Taste masking is more difficult than ordinary flavoring because the product contains a high concentration of an ionic potassium salt. Excess acidification can also alter the intended pharmacologic effect.

What formulations are protected by potassium citrate patents?

Potassium citrate's commercially important active-ingredient patents are generally expired or unavailable as a meaningful barrier to generic entry. Current protection, where present, is more likely to arise from formulation, manufacturing, packaging, or method-of-use claims than from composition-of-matter claims.

Potentially protectable subject matter includes:

• Extended-release matrix compositions.
• Specific wax, polymer, or lipid ratios.
• Tablet structures that control potassium citrate release.
• Multiparticulate or sprinkle dosage forms.
• Low-volume concentrated liquids.
• Taste-masked oral solutions.
• Pediatric or geriatric administration systems.
• Stable powder formulations.
• Packaging that controls moisture uptake.
• Combination products containing potassium citrate and another stone-prevention agent.
• Manufacturing processes that improve content uniformity or dissolution.

A formulation patent must provide a technically defensible distinction over prior potassium salt, citrate salt, controlled-release, and urinary alkalinization disclosures. Broad claims directed only to “potassium citrate in a sustained-release tablet” face substantial prior-art risk.

What patent estate strength does potassium citrate have?

Patent layer	Estimated strategic strength
Active ingredient	Very weak; mature generic compound
Composition of matter	Generally unavailable as a meaningful barrier
Conventional extended-release tablet	Weak to moderate, depending on claim specificity
Novel matrix architecture	Moderate if supported by comparative data
Taste-masked liquid	Moderate where sensory and stability data are strong
Pediatric delivery system	Moderate, with market exclusivity dependent on regulatory pathway
Manufacturing process	Moderate if process parameters produce unexpected quality benefits
Combination therapy	Moderate, but vulnerable to obviousness and enablement challenges
Packaging and moisture control	Narrow; useful as an adjunct rather than a primary barrier

When does potassium citrate lose exclusivity?

Potassium citrate has already lost the exclusivity associated with a new chemical entity. The practical U.S. market is therefore governed by generic competition, formulation-specific patents, regulatory exclusivities, and product-level barriers.

Exclusivity type	Relevance to potassium citrate
New chemical entity exclusivity	Expired or not commercially relevant
Orphan-drug exclusivity	Not generally associated with the core potassium citrate product
Pediatric exclusivity	Product-specific and requires an FDA-approved pediatric study program
New formulation exclusivity	Possible only for a qualifying new dosage form or indication
ANDA 180-day exclusivity	Possible for a first qualified Paragraph IV generic
Patent term extension	Unlikely to create a current barrier for the mature active ingredient
Data exclusivity for a new 505(b)(2) product	Potentially relevant to a genuinely novel formulation

The precise launch landscape must be assessed against the current Orange Book, FDA approval letters, and live patent records. The Orange Book identifies listed patents and regulatory exclusivity for approved reference products, but not every commercial formulation or process right.[3]

What is the Orange Book status of potassium citrate?

The Orange Book is the principal U.S. source for approved drug products, therapeutic equivalence ratings, listed patents, and certain exclusivity information.[3] Potassium citrate products may appear under different dosage-form and strength entries, including extended-release tablets and oral solutions.

For commercial diligence, an Orange Book review should identify:

• The reference listed drug for each target dosage form.
• Approved strengths and routes.
• Therapeutic equivalence codes for generic products.
• Any listed patents tied to the reference product.
• Whether a proposed product can use an ANDA or requires a 505(b)(2) application.
• Whether labeling differences create a potential carve-out issue.
• Whether a first-filer Paragraph IV opportunity remains open.

A generic product that matches the reference product's dosage form, strength, route, labeling, and performance profile is more likely to fit the ANDA pathway. A materially different delivery system, indication, concentration, or administration method may require a 505(b)(2) strategy.

Which companies are challenging potassium citrate exclusivity?

Generic potassium citrate has been commercially available from multiple manufacturers and distributors. The relevant competitive group has included large generic companies, specialty pharmaceutical manufacturers, contract manufacturers, and private-label suppliers.

Competitive review should cover:

• Urocit-K and Mission Pharmacal.
• Generic extended-release tablet suppliers.
• Generic oral-solution suppliers.
• Contract manufacturers producing private-label products.
• Specialty manufacturers targeting urology and nephrology channels.
• Veterinary suppliers using potassium citrate in animal formulations.

The existence of generic products reduces the value of an active-ingredient challenge. The more important competitive questions are supply continuity, tablet size, strength availability, wholesaler access, and whether a manufacturer can produce a differentiated product without triggering a costly clinical or regulatory program.

What Paragraph IV challenges and litigation affect potassium citrate?

Paragraph IV risk is likely to be formulation-specific rather than centered on the potassium citrate molecule. A generic applicant may challenge listed patents covering:

• Release-control matrices.
• Tablet coating or layered structures.
• Specific dissolution profiles.
• Methods of treating hypocitraturia or urinary stones.
• Formulation stability or manufacturing processes.

A Paragraph IV certification can trigger patent litigation under the Hatch-Waxman framework. If suit is filed within the statutory period, FDA approval may be subject to a 30-month stay, subject to statutory exceptions and court decisions.[4]

No single patent litigation event should be treated as a market-wide barrier without checking the patent's listed product, claim scope, expiration date, asserted claims, court docket, and settlement terms. Settlements may provide a licensed entry date, an authorized-generic arrangement, or restrictions limited to one dosage form.

What generic entry risks exist for potassium citrate?

Generic entry risk is high for conventional tablets and standard oral solutions. The principal barriers are operational rather than molecular.

Generic launch scenarios

Scenario	Expected market effect
Additional conventional tablet generic	Price erosion and formulary substitution
Low-cost oral solution	Pressure on liquid and pediatric segments
Smaller or easier-to-swallow tablet	Potential premium positioning
Novel sprinkle or multiparticulate product	Differentiated adherence segment
505(b)(2) concentrated liquid	Possible niche protection if clinically justified
Supply-constrained generic market	Temporary pricing support for reliable manufacturers
Authorized generic launch	Rapid pressure on branded product revenue

A generic entrant can compete effectively without developing a new excipient platform if it reproduces the established release profile. Differentiation therefore requires a measurable patient or manufacturing advantage.

How does potassium citrate compare with competing urinary alkalinizers?

Potassium citrate competes with sodium citrate, potassium-sodium citrate, citric acid mixtures, and bicarbonate-based alkalinizers. Potassium citrate is attractive when sodium loading is undesirable, but it carries hyperkalemia risk in susceptible patients and has a high pill burden.

Product type	Primary advantage	Primary limitation
Potassium citrate	Raises urinary citrate without sodium loading	Potassium-related safety risk; large tablets
Sodium citrate	Lower potassium exposure	Adds sodium load
Potassium-sodium citrate	Combined citrate delivery	Adds both potassium and sodium
Citrate solution	Flexible dosing and easier swallowing	Taste, stability, and measuring burden
Bicarbonate products	Low cost and broad availability	Less targeted citrate replacement; sodium or potassium exposure

The excipient opportunity is strongest where the dosage form improves adherence without increasing potassium exposure per dose.

What commercial opportunities exist for potassium citrate excipients?

The most attractive opportunities are product platforms rather than commodity excipient sales.

High-priority opportunities

1. A smaller extended-release tablet with equivalent potassium delivery and dissolution performance.
2. A palatable, low-volume liquid for pediatric, geriatric, and dysphagic patients.
3. A unit-dose powder or granule that disperses in water without sedimentation or excessive foaming.
4. A multiparticulate sprinkle formulation for patients unable to swallow tablets.
5. A moisture-resistant formulation for hot and humid markets.
6. A veterinary formulation with species-appropriate dosing and flavor.
7. A combination product with complementary stone-prevention therapy.
8. A private-label platform that supports several potassium citrate strengths.

Revenue exposure

The branded product is exposed to generic substitution because potassium citrate is a mature small-molecule therapy. Revenue defense depends on maintaining brand preference, securing supply, offering differentiated strengths or dosage forms, and protecting any novel formulation through patents and regulatory exclusivity.

For a new entrant, the addressable commercial segments are more likely to be:

• Premium adherence products.
• Pediatric and geriatric formulations.
• Specialty urology distribution.
• Veterinary products.
• International markets with limited generic penetration.
• Contract development and manufacturing.
• Excipient or formulation licensing.

How should a potassium citrate formulation be patented?

A defensible filing strategy should combine composition, process, performance, and use claims where the data support them.

The strongest evidence package would include:

• Comparative dissolution against the reference product.
• Fed and fasted performance data.
• Stability at accelerated and long-term conditions.
• Moisture challenge studies.
• Tablet hardness and friability data.
• Dose uniformity and content uniformity.
• Gastric irritation or tolerability evidence where available.
• Palatability data for liquids or powders.
• Manufacturing-scale reproducibility.
• Comparative tablet-size or dose-burden measurements.

The patent should avoid relying exclusively on broad excipient classes. Specific ratios, particle-size distributions, coating weights, processing conditions, and release profiles are more likely to establish technical distinction, although claim validity remains dependent on the prior art and written-description support.

What FDA regulatory strategy applies to a new potassium citrate formulation?

A conventional generic tablet may qualify for an ANDA if it matches the reference product's relevant characteristics and demonstrates bioequivalence or the applicable product-specific performance requirements.

A differentiated product may require a 505(b)(2) application when it relies partly on FDA findings for an approved product but introduces a meaningful change, such as:

• New dosage form.
• New concentration.
• New route or administration method.
• New delivery technology.
• New indication.
• Clinically relevant dosing modification.

FDA's Orange Book, product-specific guidance, approved labeling, and applicable dissolution or bioequivalence requirements should drive the pathway analysis.[3,5]

Key Takeaways

• Potassium citrate is a mature generic drug with limited active-ingredient exclusivity.
• The main commercial battleground is dosage form, not molecule ownership.
• Extended-release matrix performance, tablet size, taste, and adherence are the highest-value formulation variables.
• Conventional generic entry risk is high.
• Patent value is concentrated in narrow formulation, process, packaging, and method-of-use claims.
• The strongest new-product opportunities are low-volume liquids, pediatric formats, multiparticulates, powders, veterinary products, and smaller extended-release tablets.
• A 505(b)(2) strategy may be appropriate for a clinically or technically differentiated delivery system.
• Current Orange Book and litigation diligence is essential before relying on any patent or exclusivity conclusion.

FAQs About Potassium Citrate Excipient and Patent Strategy

Can potassium citrate be formulated as a chewable tablet?

Yes, but taste masking and potassium-load management are substantial challenges. A chewable product would need a robust palatability system, acceptable tablet mass, and evidence that chewing does not create excessive local potassium exposure or an unsuitable release profile.

Which excipients are most suitable for potassium citrate oral solutions?

Suitable systems may include purified water, sweeteners, flavorants, viscosity modifiers, buffers, and preservatives where justified. The formulation must control taste, microbial stability, pH, precipitation, and container compatibility.

Is potassium citrate suitable for a sustained-release capsule?

Yes. Multiparticulate pellets, granules, or mini-tablets can be filled into capsules. This may improve swallowability and support sprinkle administration, but it increases manufacturing and dose-uniformity complexity.

Can an excipient supplier obtain patent protection for a potassium citrate product?

An excipient supplier generally needs a formulation or process invention tied to a specific potassium citrate product. Patentable subject matter may include a novel matrix, coating system, processing sequence, stability improvement, or release profile supported by comparative data.

Are biosimilars relevant to potassium citrate?

No. Potassium citrate is a small-molecule salt, not a biologic. Competitive entry occurs through generic-drug pathways, formulation development, and, for materially differentiated products, potentially the 505(b)(2) pathway.

References

1. Mission Pharmacal Company. (2023). Urocit-K potassium citrate extended-release tablets: Prescribing information. DailyMed, U.S. National Library of Medicine.

2. U.S. National Library of Medicine. (2024). DailyMed: Potassium citrate extended-release tablets and oral solution labeling. https://dailymed.nlm.nih.gov/

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

4. U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications. https://www.fda.gov/drugs

5. U.S. Food and Drug Administration. (2024). Generic drug guidance and product-specific guidances. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.