List of Excipients in Branded Drug CATAFLAM

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Generic Drugs Containing CATAFLAM

Company	Ingredient	NDC	Excipient
BLUCREST PHARMACEUTICALS LLC	diclofenac potassium	73684-150	FERRIC OXIDE RED
BLUCREST PHARMACEUTICALS LLC	diclofenac potassium	73684-150	FERRIC OXIDE YELLOW
BLUCREST PHARMACEUTICALS LLC	diclofenac potassium	73684-150	HYDROXYETHYL CELLULOSE
BLUCREST PHARMACEUTICALS LLC	diclofenac potassium	73684-150	MAGNESIUM STEARATE
BLUCREST PHARMACEUTICALS LLC	diclofenac potassium	73684-150	METHYL ALCOHOL
BLUCREST PHARMACEUTICALS LLC	diclofenac potassium	73684-150	POLYETHYLENE GLYCOL
BLUCREST PHARMACEUTICALS LLC	diclofenac potassium	73684-150	POVIDONE

What are the Most Frequently-Used Excipients in CATAFLAM?

# Of NDCs	Excipient
1	FERRIC OXIDE RED
1	FERRIC OXIDE YELLOW
1	HYDROXYETHYL CELLULOSE
1	MAGNESIUM STEARATE
1	METHYL ALCOHOL
1	POLYETHYLENE GLYCOL
1	POVIDONE

Cataflam Excipient Strategy and Commercial Opportunities for Diclofenac Potassium

Last updated: October 16, 2026

Cataflam is an immediate-release oral tablet containing diclofenac potassium, a nonsteroidal anti-inflammatory drug used for acute pain and primary dysmenorrhea. Its commercial value now lies in formulation optimization, differentiated delivery, manufacturing efficiency, and market-specific generic positioning rather than protection of the original active ingredient. The strongest opportunities are low-cost immediate-release tablets, rapid-onset dosage forms, pediatric or liquid presentations, and combination products that improve adherence or target defined pain conditions.

What is Cataflam and which active ingredient does it contain?

Cataflam contains diclofenac potassium, generally at a 50 mg strength in the original immediate-release tablet. Diclofenac potassium is the potassium salt of diclofenac and differs from diclofenac sodium in salt form, dissolution behavior, labeling, and dosage-form history.

Cataflam has been used for:

• Acute musculoskeletal pain
• Postoperative or dental pain
• Primary dysmenorrhea
• Short-term inflammatory pain

The drug is not an extended-release product. Its commercial positioning has historically depended on relatively rapid dissolution and oral absorption rather than prolonged exposure.

Attribute	Cataflam profile
Active ingredient	Diclofenac potassium
Drug class	NSAID
Principal dosage form	Immediate-release tablet
Common strength	50 mg
Original commercial positioning	Acute pain and dysmenorrhea
Regulatory pathway	Small-molecule drug application
Main current competition	Generic diclofenac potassium tablets and other NSAIDs
Primary formulation issue	Rapid disintegration and dissolution with acceptable tablet robustness
Key safety limitation	Gastrointestinal, cardiovascular, renal and hepatic NSAID risks

The FDA-approved labeling identifies diclofenac potassium as the active pharmaceutical ingredient and describes the product as an immediate-release oral tablet (U.S. Food and Drug Administration [FDA], 2011).

What excipients are used in Cataflam tablets?

Cataflam’s excipient system is designed to support direct compression or wet-granulation processing, rapid tablet breakup, powder flow, lubrication, and film coating. Exact excipients can vary by country, manufacturing site, strength, and historical product version.

Public product information has identified excipient categories including:

• Lactose or another water-soluble diluent
• Maize or corn starch
• Povidone as a binder
• Sodium starch glycolate as a disintegrant
• Colloidal anhydrous silica as a glidant
• Magnesium stearate as a lubricant
• Film-coating components, including polymers, plasticizers, pigments and opacifiers

The formulation objective is not maximum mechanical strength. It is a controlled balance between hardness and rapid disintegration. Excessive compression force, hydrophobic lubricant exposure, or high polymer binder content can delay dissolution.

What is the function of each major excipient?

Excipient category	Typical function in a diclofenac potassium tablet	Commercial and technical consideration
Lactose or alternative diluent	Adds bulk and improves compactability	Lactose creates compatibility and labeling constraints for some patient groups
Maize starch	Filler and disintegration aid	Supports tablet breakup but can increase variability if moisture is poorly controlled
Povidone	Binder and granulation aid	Excess levels can slow dissolution and increase granule hardness
Sodium starch glycolate	Rapid swelling and disintegration	Sensitive to processing conditions and overcompression
Colloidal silica	Improves flow and reduces segregation	High levels can affect compaction and dust handling
Magnesium stearate	Reduces ejection force and tooling adhesion	Overlubrication can produce hydrophobic tablets and slower dissolution
Film former	Protects the core and improves appearance	Must not create a dissolution barrier
Plasticizer	Improves coating flexibility	Excess can increase tackiness and prolong drying
Pigment or opacifier	Provides color and light protection	Supports product identification and brand differentiation

An alternative generic formulation does not need to replicate the Cataflam excipient profile. It must satisfy the applicable quality, bioequivalence, dissolution, stability and impurity requirements for the relevant jurisdiction.

How should a manufacturer design an excipient strategy for diclofenac potassium?

The preferred strategy is a low-complexity immediate-release formulation with excipients selected for robust dissolution across normal manufacturing variation.

1. Protect rapid dissolution

Diclofenac potassium has limited aqueous solubility relative to highly soluble salts. The tablet should disintegrate rapidly and avoid excipients that form a viscous barrier around drug particles.

Critical controls include:

• Disintegrant concentration and distribution
• Granule porosity
• Compression force
• Lubrication time
• Core hardness
• Coating weight gain
• Dissolution performance across pH conditions

A formulation that passes dissolution only at nominal compression force carries avoidable commercial risk.

2. Manage salt and microenvironmental pH

The potassium salt provides a different solid-state and dissolution profile from diclofenac acid or diclofenac sodium. Excipients that alter microenvironmental pH can affect dissolution, stability and impurity formation.

Acidic excipients should be assessed for:

• Local conversion toward diclofenac acid
• Changes in dissolution rate
• Salt disproportionation
• Moisture-mediated degradation
• Interaction with alkaline or carbonate-containing materials

The formulation should avoid unnecessary pH modifiers unless they deliver a measurable benefit.

3. Control moisture

Moisture can affect tablet hardness, disintegration, coating performance and chemical stability. Hygroscopic excipients may create stability problems even when the active ingredient itself remains within specification.

A commercial formulation should evaluate:

• Water activity
• Packaging moisture transmission
• Blister versus bottle storage
• Granulation endpoint
• Tablet residual moisture
• Accelerated stability at high humidity

Alu-Alu blister packaging can provide a stronger moisture barrier than standard high-density polyethylene bottles but may raise packaging cost.

4. Evaluate lactose-free alternatives

Lactose is inexpensive and widely accepted, but lactose-free formulations can broaden institutional and international market access. Potential alternatives include:

• Microcrystalline cellulose
• Mannitol
• Dibasic calcium phosphate
• Pregelatinized starch
• Spray-dried co-processed excipients

Each alternative changes compression behavior, tablet size, mouthfeel, dissolution and manufacturing cost. Mannitol may support premium oral-dispersible products but is usually less attractive for a low-cost standard tablet.

5. Limit lubricant sensitivity

Magnesium stearate remains commercially attractive because it is effective at low concentrations. The formulation should control lubricant addition time and mixing intensity. Prolonged blending can lower tablet tensile strength and slow wetting.

Alternative lubricants, such as sodium stearyl fumarate, may improve dissolution robustness but can increase raw-material cost or require process redevelopment.

What formulations are protected by Cataflam-related intellectual property?

The original Cataflam active-ingredient and basic immediate-release tablet rights are old and do not provide a meaningful barrier to ordinary generic entry in the United States and other mature markets. Commercial protection now depends on regulatory status, trademarks, manufacturing know-how, country-specific formulation patents, and any later rights covering particular delivery systems.

Potentially protectable formulation concepts include:

• Rapid-release diclofenac potassium tablets
• Effervescent diclofenac potassium compositions
• Oral powders or granules
• Orodispersible tablets
• Liquid suspensions
• Soft gelatin capsules
• Fixed-dose combinations
• Gastroprotective combinations
• Modified-release or pulsatile-release systems
• Taste-masked pediatric formulations

A competitor cannot safely assume that the absence of a live basic-product patent eliminates all IP risk. Later patents may cover a specific excipient ratio, particle-size distribution, manufacturing process, dissolution profile, packaging configuration or therapeutic combination.

Patent analysis must be performed by jurisdiction and product version. Historical Cataflam patents are not a reliable proxy for current freedom to operate because many rights have expired, been abandoned, or become commercially irrelevant.

When does Cataflam lose exclusivity?

Cataflam’s practical market exclusivity has already ended in major generic markets. Diclofenac itself was discovered and commercialized decades ago, and diclofenac potassium tablets are available from multiple manufacturers.

The relevant exclusivity categories are:

Exclusivity type	Current commercial relevance
Active-ingredient patent	Generally expired in mature markets
Original immediate-release formulation patent	Generally expired or no longer commercially blocking
Brand trademark	May remain active but does not prevent generic approval
Regulatory exclusivity	No longer the principal barrier for the original product
Later formulation patents	May apply to specific products or delivery technologies
Manufacturing know-how	Can remain valuable without creating statutory market exclusivity

In the United States, generic diclofenac potassium tablets are regulated through abbreviated new drug applications. The Orange Book remains the relevant source for current listed patents and reference-product status, but listing status can change over time and must be checked against the current edition (FDA, n.d.-a).

What is the Orange Book status of Cataflam?

Cataflam is associated with a U.S. prescription drug application for diclofenac potassium tablets. The original product has been subject to generic competition, and the economic importance of any remaining Orange Book listing is limited compared with the product’s historical exclusivity period.

A manufacturer assessing entry should review:

• Current reference listed drug status
• Active Orange Book patent listings
• Pediatric exclusivity, if any
• Approved strengths and dosage forms
• Marketing status of the reference product
• Existing generic approvals
• Paragraph IV certifications for any listed patents

The Orange Book does not establish freedom to operate for patents that are not eligible for listing, including many manufacturing, formulation, process and use patents.

Which companies are challenging Cataflam with generic products?

Generic diclofenac potassium tablets have been marketed by multiple manufacturers and distributors across the United States and international markets. The competitive field includes:

• Large generic manufacturers
• Regional pharmaceutical companies
• Contract manufacturers
• Private-label distributors
• Hospital and institutional suppliers

The commercial threat is not concentrated in a single challenger. It is a multi-supplier market in which price, supply continuity, approved packaging, wholesaler access and product availability determine share.

Generic entry is usually easier for a standard 50 mg immediate-release tablet than for a differentiated liquid, rapidly disintegrating tablet, combination product or modified-release dosage form.

What Paragraph IV challenges and litigation affect Cataflam?

Paragraph IV litigation is unlikely to be the main barrier for the original Cataflam immediate-release tablet because the core product is mature and generic versions have been available. Paragraph IV risk becomes more relevant when a company seeks approval for:

• A patented rapid-release formulation
• A novel salt or polymorph
• A new delivery system
• A fixed-dose combination
• A method of use with a listed patent
• A product relying on a recently approved reference formulation

For the original product, the more important legal risks are usually:

• Product-liability litigation
• Labeling and pharmacovigilance disputes
• Trademark and trade-dress claims
• Patent disputes over later formulations
• ANDA technical or bioequivalence challenges
• Supply and manufacturing compliance issues

A launch strategy should distinguish patent invalidity risk from commercial litigation risk. The first concerns legal market entry. The second can affect cost, timing and product continuity after approval.

How strong is the patent estate for Cataflam?

The patent estate for the original Cataflam tablet is weak as a barrier to standard generic competition. The strongest remaining protection, where it exists, is more likely to attach to a specific reformulation than to diclofenac potassium itself.

Patent asset	Relative strength for generic blocking
Original diclofenac compound patent	Very low due to age and expiry
Original Cataflam tablet patent	Low
Brand trademark	Moderate against confusing branding, not against generic approval
Novel rapid-release formulation	Potentially moderate to strong
Pediatric taste-masked formulation	Potentially moderate
Manufacturing process patent	Variable and difficult to enforce commercially
Fixed-dose combination patent	Potentially strong if claims are narrow and valid
Method-of-use patent	Depends on labeling, claim scope and induced-infringement evidence

The commercial value of a later patent depends on claim breadth, enforceability, regulatory listing, product differentiation and the availability of design-around options.

What are the best commercial opportunities for Cataflam reformulation?

Low-cost generic immediate-release tablets

This is the largest and lowest-risk opportunity. A manufacturer can compete through:

• Lower tablet cost
• Smaller tablet size
• Lactose-free composition
• Improved packaging
• Reliable supply
• Institutional contracts
• Multiple approved strengths

The market is price-sensitive, so excipient innovation must reduce manufacturing cost or improve approval and supply performance.

Rapid-onset oral dosage forms

A rapidly disintegrating tablet, orally disintegrating tablet or oral granule could support a stronger product position for acute pain. The technical challenge is balancing:

• Diclofenac taste
• Tablet friability
• Moisture sensitivity
• Drug loading
• Mouthfeel
• Dissolution speed
• Packaging requirements

Taste masking may require polymer coating, ion-exchange resin, cyclodextrin complexation or coated microparticles. Each option increases process complexity and may affect bioequivalence.

Liquid and pediatric formulations

A diclofenac potassium oral solution or suspension could target patients who cannot swallow tablets. It would require careful assessment of:

• Pediatric dosing accuracy
• Taste masking
• Chemical stability
• Preservative system
• Suspending agents
• Microbial control
• Container compatibility
• Dosing-device accuracy

The pediatric opportunity is commercially attractive but carries greater regulatory and formulation risk than a conventional tablet.

Combination products

Potential combinations include diclofenac with:

• Paracetamol or acetaminophen
• A proton-pump inhibitor
• A muscle relaxant
• A gastrointestinal protective agent
• A migraine-directed active ingredient

Combination products can create new patent and regulatory value. They also increase interaction, labeling, clinical, and manufacturing requirements. A combination with a gastroprotective agent may offer a commercial rationale, but it does not remove the underlying NSAID cardiovascular and renal risks.

Soft gelatin capsules

A liquid-filled softgel can improve swallowing and may offer faster dispersion than a conventional tablet. It requires control of:

• Fill uniformity
• Shell compatibility
• Moisture transfer
• Seal integrity
• Diclofenac potassium solubility in the fill vehicle
• Long-term migration and leakage

Softgels often carry higher manufacturing costs but can support consumer-facing differentiation.

How does Cataflam compare with diclofenac sodium products?

Attribute	Diclofenac potassium, Cataflam type	Diclofenac sodium products
Salt	Potassium	Sodium
Typical positioning	Acute pain and dysmenorrhea	Pain and inflammatory conditions, including chronic use
Common immediate-release form	Tablet	Tablet or capsule depending on market
Release profile	Immediate release	Immediate, delayed or extended release depending on product
Generic competition	Extensive	Extensive
Differentiation opportunity	Rapid onset, liquid, ODT, combination	Enteric coating, sustained release, topical and combination products
Main formulation focus	Fast disintegration and dissolution	Release control, gastric protection or topical delivery

Salt selection alone is unlikely to create durable commercial differentiation. Product value must come from delivery performance, adherence, tolerability positioning, or channel strategy.

What FDA regulatory status applies to new Cataflam-type products?

A conventional diclofenac potassium tablet may qualify for an ANDA if it references an approved product and meets applicable bioequivalence and quality requirements. A materially different dosage form or combination may require a different regulatory pathway, including a 505(b)(2) application in the United States.

The regulatory route depends on:

• Active ingredient and salt
• Dosage form
• Strength
• Release profile
• Reference product
• Indication
• Combination status
• Clinical evidence requirements

Bioequivalence is not established by dissolution alone. Pharmacokinetic studies, comparative dissolution, formulation similarity and product-specific FDA requirements determine the approval package. FDA labeling also requires prominent NSAID warnings concerning cardiovascular and gastrointestinal risks (FDA, 2011; FDA, 2015).

What manufacturing and IP barriers matter most?

The main barriers are operational rather than compound-patent barriers.

Manufacturing barriers

• API particle-size variability
• Poor powder flow
• Salt-state control
• Lubrication sensitivity
• Tablet sticking and capping
• Dissolution drift after scale-up
• Moisture ingress
• Coating-induced release delay
• Supplier qualification for specialty excipients

IP barriers

• Patents on rapid-release compositions
• Claims directed to particle size or solid form
• Combination-product patents
• Taste-masking claims
• Modified-release systems
• Process patents with narrow but enforceable parameters
• Trademarks and trade dress

A formulation that uses conventional excipients and established processing techniques is generally easier to design around than one dependent on a patented excipient architecture.

What revenue exposure exists for a Cataflam-type product?

Revenue exposure is concentrated in high-volume, low-margin markets. Standard diclofenac potassium tablets can generate meaningful unit volume but face price erosion once several generic suppliers enter.

Revenue potential is higher when the product has:

• Rapid onset supported by measurable dissolution performance
• A differentiated dosage form
• Pediatric or swallowing-patient utility
• Institutional or government procurement access
• A combination product with clinical or adherence rationale
• Reliable supply in markets with periodic shortages

A standard tablet strategy should prioritize manufacturing cost and supply reliability. A reformulation strategy should prioritize defensible differentiation and evidence that prescribers, pharmacists or patients will pay for it.

Key Takeaways

• Cataflam is an immediate-release diclofenac potassium product, commonly associated with the 50 mg tablet.
• Its original compound and basic tablet exclusivity are no longer meaningful barriers to generic entry in mature markets.
• The core excipient strategy is built around rapid disintegration, acceptable compactability, controlled lubrication and moisture stability.
• Lactose, starch, povidone, sodium starch glycolate, colloidal silica and magnesium stearate are representative excipient categories, but market-specific formulations can differ.
• The strongest commercial opportunities are low-cost generic tablets, rapid-onset dosage forms, orally disintegrating products, pediatric liquids, softgels and selected combination products.
• Later formulation patents may remain relevant even though the original Cataflam estate is mature.
• The most important risks are dissolution drift, salt-state behavior, moisture sensitivity, NSAID labeling requirements and price erosion.
• A conventional tablet is primarily a scale and supply-chain opportunity. A differentiated dosage form is primarily an IP and regulatory opportunity.

FAQs

Is diclofenac potassium more commercially valuable than diclofenac sodium?

Not inherently. Diclofenac potassium can support acute-pain positioning and rapid-release products, while diclofenac sodium has a broader history across immediate-, delayed- and extended-release dosage forms. Commercial value depends on formulation, channel and differentiation.

Can a lactose-free Cataflam generic obtain market advantage?

Yes, but the advantage is usually modest for a standard prescription tablet. It becomes more meaningful in institutional procurement, patient-specific pharmacy markets and products positioned for excipient sensitivity.

Is an orally disintegrating diclofenac potassium tablet patentable?

Potentially. Patentability depends on the claimed formulation, technical effect, prior art and jurisdiction. A generic ODT is not automatically blocked by patents covering the conventional Cataflam tablet.

What is the biggest formulation failure mode for diclofenac potassium tablets?

The most common strategic failure is loss of rapid dissolution after scale-up. Excessive compression, over-lubrication, excessive binder or a high-weight-gain coating can produce a tablet that meets physical specifications but releases drug too slowly.

Does a new excipient combination require new clinical trials?

Not necessarily. A conventional generic formulation may rely on bioequivalence and quality testing. A new dosage form, new indication, combination product or materially different release profile may require additional clinical or pharmacokinetic evidence.

References

1. U.S. Food and Drug Administration. (2011). Cataflam (diclofenac potassium) tablets: Prescribing information. U.S. Department of Health and Human Services.

2. U.S. Food and Drug Administration. (2015). Drug safety communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs increase chance of heart attack or stroke. U.S. Department of Health and Human Services.

3. U.S. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

4. DailyMed. (n.d.). Diclofenac potassium tablet prescribing information. U.S. National Library of Medicine.

5. U.S. Food and Drug Administration. (n.d.-b). Guidance for industry: Bioavailability and bioequivalence studies submitted in support of abbreviated new drug applications. U.S. Department of Health and Human Services.