List of Excipients in Branded Drug MECLOFENAMATE SODIUM

Generic Drugs Containing MECLOFENAMATE SODIUM

Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	meclofenamate sodium	0378-2150	CELLULOSE, MICROCRYSTALLINE
Mylan Pharmaceuticals Inc	meclofenamate sodium	0378-2150	D&C YELLOW NO. 10
Mylan Pharmaceuticals Inc	meclofenamate sodium	0378-2150	FD&C BLUE NO. 1
Mylan Pharmaceuticals Inc	meclofenamate sodium	0378-2150	FD&C BLUE NO. 2
Mylan Pharmaceuticals Inc	meclofenamate sodium	0378-2150	FD&C RED NO. 3
Mylan Pharmaceuticals Inc	meclofenamate sodium	0378-2150	FD&C RED NO. 40

What are the Most Frequently-Used Excipients in MECLOFENAMATE SODIUM?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	D&C YELLOW NO. 10
1	FD&C BLUE NO. 1
1	FD&C BLUE NO. 2
1	FD&C RED NO. 3
1	FD&C RED NO. 40

Last updated: September 16, 2026

Meclofenamate sodium is a mature, generic oral NSAID with limited opportunity for conventional abbreviated-new-drug exclusivity. Commercial value is concentrated in reliable capsule supply, excipient optimization, differentiated dosage forms, regional registrations, and lifecycle formulations that improve gastrointestinal tolerability or adherence. The molecule’s sodium-salt chemistry supports immediate-release oral delivery, but its low market visibility, class-wide safety restrictions, and competition from inexpensive NSAIDs limit the size of the opportunity.

Meclofenamate Sodium Excipient Strategy and Commercial Opportunities

What is meclofenamate sodium and how is it supplied?

Meclofenamate sodium is the sodium salt of meclofenamic acid, an anthranilic-acid NSAID. It was marketed in the United States under the Meclomen brand and is associated with oral capsule strengths of 50 mg and 100 mg. The drug is used for short-term treatment of mild to moderate pain and dysmenorrhea, subject to NSAID class warnings and prescribing restrictions.[1]

Attribute	Meclofenamate sodium
Active ingredient	Meclofenamate sodium
Pharmacologic class	Anthranilic-acid NSAID
Common dosage form	Immediate-release oral capsule
Historical strengths	50 mg and 100 mg
Molecular formula	C14H10Cl2NNaO2
Molecular weight	Approximately 318.13 g/mol
Route	Oral
Regulatory pathway	Conventional small-molecule prescription drug
Primary commercial issue	Low-volume generic supply and limited differentiation
Main formulation concern	Content uniformity, dissolution, stability, and GI tolerability

Meclofenamate sodium is distinct from mefenamic acid, although both belong to the fenamate NSAID class. Substitution between the two compounds is not appropriate for regulatory or formulation purposes.

What excipients are suitable for meclofenamate sodium capsules?

The most commercially practical platform is an immediate-release hard gelatin or hypromellose capsule using a dry powder blend or granulated fill. Excipients should support blend uniformity, rapid disintegration, reproducible dissolution, chemical stability, and low manufacturing cost.

Recommended excipient classes

Formulation function	Potential excipient classes	Commercial rationale
Diluent	Microcrystalline cellulose, lactose monohydrate, mannitol, dibasic calcium phosphate	Controls fill weight and improves powder handling
Binder	Povidone, copovidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule strength and reduces segregation
Disintegrant	Croscarmellose sodium, sodium starch glycolate, crospovidone	Supports immediate release
Glidant	Colloidal silicon dioxide	Improves flow and capsule-filling consistency
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces equipment friction
Wetting agent	Polysorbate 80 or sodium lauryl sulfate, where justified	May improve dissolution of poorly wettable drug particles
Capsule shell	Gelatin or hypromellose	Enables standard oral presentation and vegetarian positioning
Opacifier or colorant	Titanium dioxide alternatives, iron oxides, approved capsule colorants	Supports product identification and light protection

The preferred first-line design is usually a low-complexity formulation based on microcrystalline cellulose, a superdisintegrant, colloidal silicon dioxide, and a low-level lubricant. Lactose may reduce cost but can create compatibility, moisture, or patient-specific excipient constraints. Mannitol can improve mouthfeel and provide a lower-hygroscopicity option, although it is more expensive.

Why microcrystalline cellulose is commercially attractive

Microcrystalline cellulose provides acceptable flow, compressibility, and capsule-fill performance. It is widely available from multiple suppliers and is familiar to regulators. It can support direct blending or dry granulation, reducing process complexity.

Its principal limitations are variable flow across grades, potential segregation from a low-dose active ingredient, and sensitivity to particle-size distribution. Meclofenamate sodium capsules should therefore be assessed for blend uniformity at commercial scale rather than relying only on laboratory mixing performance.

When is wet granulation justified?

Wet granulation is justified when the active pharmaceutical ingredient has poor flow, high electrostatic charging, unacceptable segregation, or inadequate content uniformity in a direct-blend process. It can also improve dissolution if the active is poorly dispersed in the capsule fill.

Wet granulation increases manufacturing cost and introduces water and drying controls. For a low-price generic NSAID, that cost must be balanced against yield loss, dissolution variability, and batch-release risk. A dry-granulation process may provide a middle ground if roller compaction produces acceptable granule strength without excessive fines.

How should excipient selection address meclofenamate sodium solubility and dissolution?

Meclofenamate sodium is more suitable for oral formulation than the free acid because the sodium salt provides a salt-form advantage in aqueous media. The salt form does not eliminate dissolution risk. Particle size, agglomeration, wetting, lubricant concentration, and capsule-fill density can materially affect release.

A development program should compare:

1. Direct blend versus dry granulation.
2. Microcrystalline cellulose versus lactose or mannitol as the principal diluent.
3. Crospovidone versus croscarmellose sodium as the disintegrant.
4. Magnesium stearate versus sodium stearyl fumarate as the lubricant.
5. Standard versus micronized active-material particle size.
6. Gelatin versus hypromellose capsule shells.
7. With and without a low-level wetting agent.

The critical quality attributes are assay, content uniformity, degradation products, water content, capsule integrity, disintegration, and dissolution. Dissolution testing should include the approved compendial method, development-stage discriminatory conditions, and stability time points.

A formulation that dissolves rapidly under a single medium but fails under agitation, pH, or storage stress may create regulatory and commercial problems. Excipient changes should be assessed under the relevant FDA postapproval change framework, including the scale and impact of the change.[2]

What formulation patents could protect a meclofenamate sodium product?

The original active-ingredient and basic oral dosage-form protection for a drug approved in the late twentieth century would ordinarily be expired. The principal opportunity is therefore not a new chemical entity patent. It is a narrow formulation or process patent, if the product delivers a measurable technical advantage.

Potential patentable concepts include:

• A specific particle-size distribution that improves dissolution or reduces variability.
• A moisture-controlled capsule fill that improves stability.
• A defined dry-granulation process with improved content uniformity.
• A capsule formulation with a particular excipient ratio.
• A modified-release dosage form.
• A gastroretentive or enteric-delivery system.
• A fixed-dose combination with another analgesic or antispasmodic.
• A formulation designed to reduce peak exposure while maintaining efficacy.
• A multiparticulate system with delayed or pulsatile release.

The strongest formulation claims would need comparative data against a conventional immediate-release capsule. A claim based only on routine excipient substitution is vulnerable to obviousness and lack of unexpected results. For this molecule, formulation patent value depends on demonstrated improvement in dissolution, stability, tolerability, adherence, or manufacturing robustness.

What is the FDA regulatory status and Orange Book position of meclofenamate sodium?

Meclofenamate sodium is a conventional small-molecule prescription product, not a biologic. It is subject to the abbreviated new drug application pathway when a sponsor can demonstrate pharmaceutical equivalence and bioequivalence to an appropriate reference product.[3]

The product’s regulatory profile has several implications:

• Biosimilar development is not relevant because meclofenamate sodium is not a biologic.
• Generic competition is legally feasible once applicable reference-product and exclusivity barriers are absent.
• The principal regulatory work concerns active-ingredient control, dosage-form equivalence, bioequivalence, manufacturing quality, and labeling.
• Orange Book relevance depends on whether an approved reference product and associated patents or exclusivity are currently listed.
• Historical approval does not guarantee active commercial availability.

For a current launch assessment, the sponsor should distinguish between an approved application, an actively marketed product, a discontinued product, and an FDA reference-listed drug. FDA’s Orange Book and Drugs@FDA databases are the controlling sources for current listing and approval information.[3,4]

When did meclofenamate sodium lose market exclusivity?

The commercial exclusivity associated with an early meclofenamate sodium product would have expired many years ago. Any original compound, composition, or basic oral-use patent would be expected to be outside its enforceable term based on the product’s historical approval period.

The relevant current questions are narrower:

Exclusivity category	Relevance to meclofenamate sodium
New chemical entity exclusivity	Expired
Original composition patent	Expected to be expired
Pediatric exclusivity	No current commercial significance identified
Orphan exclusivity	Not a primary basis for the product
Formulation patent	Possible only for a later, differentiated product
Method-of-use patent	Possible but likely narrow and indication-specific
Generic first-filer exclusivity	Depends on any current ANDA and Paragraph IV activity
Regulatory exclusivity	Must be checked against current FDA records

A generic sponsor should not assume that an old molecule is entirely free of patent risk. Later patents can cover a delivery system, particular patient population, dosing regimen, or manufacturing process. Those rights would not restore broad exclusivity to the active ingredient.

Are Paragraph IV challenges or generic-entry barriers significant?

Paragraph IV risk is likely to be limited for a mature product unless a current reference product has unexpired listed patents. The central commercial barrier is more likely to be market economics than patent litigation.

Potential generic-entry issues include:

• The absence of a commercially active reference product.
• Difficulty identifying a current reference-listed drug.
• Low projected annual volume.
• Limited supply of qualified active pharmaceutical ingredient.
• Bioequivalence variability caused by formulation differences.
• Small capsule-fill weights and blend-uniformity challenges.
• Buyer preference for established NSAIDs such as ibuprofen, naproxen, or diclofenac.
• Low reimbursement or restricted formulary placement.

If a sponsor develops a new modified-release or combination product, the patent and regulatory profile changes. A 505(b)(2) application may be appropriate where the product relies partly on published literature or an approved product but introduces a new dosage form, route, strength, or formulation. That pathway can create a more defensible product position than a conventional ANDA, although it requires a stronger clinical and regulatory justification.[5]

What commercial opportunities exist for meclofenamate sodium?

1. Reliable supply for underserved generic demand

A manufacturer can compete through consistent availability, quality performance, and multi-source API qualification. Mature products often experience intermittent shortages or limited supplier participation because volumes are modest. A dependable supplier can capture hospital, institutional, and distributor business without owning a large patent estate.

2. Regional registration and export markets

The product may be commercially relevant in jurisdictions where fenamate NSAIDs remain prescribed and generic competition is limited. The business case depends on local registration requirements, pharmacopoeial standards, import controls, and tender pricing.

Geographic expansion should prioritize countries with:

• Existing recognition of the active ingredient.
• A clear generic or abridged registration pathway.
• Local demand for prescription NSAIDs.
• Limited competition in 50 mg and 100 mg capsules.
• Acceptable reimbursement or private-market pricing.

3. Hypromellose capsules and excipient differentiation

A gelatin-free capsule can address vegetarian, religious, or supply-chain requirements. This is a modest commercial differentiator, not a major clinical advantage. It has value when supported by regional market demand or institutional procurement specifications.

4. Improved manufacturing robustness

A formulation with lower segregation, faster encapsulation, lower rejection rates, and stable dissolution may generate greater value than a novel excipient claim. Process patents, trade secrets, and supplier qualification can protect this advantage even when the finished product is not clinically differentiated.

5. Modified-release products

A modified-release product could target reduced dosing frequency or smoother exposure. It would require substantial development work because NSAID pharmacokinetics, efficacy, peak exposure, and gastrointestinal safety must be characterized. A modified-release product should not be marketed as safer merely because the release profile is altered.

6. Combination products

Potential combinations include an analgesic, antispasmodic, or gastroprotective agent. These products would face clinical, regulatory, and patent hurdles. The combination must provide a clear therapeutic or adherence benefit rather than simply combine low-cost ingredients.

How does meclofenamate sodium compare with competing NSAIDs?

Product	Competitive position	Formulation opportunity	Main commercial constraint
Meclofenamate sodium	Mature, niche fenamate NSAID	Reliable capsule supply, modified release, regional products	Low awareness and small market
Mefenamic acid	Closely related fenamate	Capsule, tablet, suspension, combination products	Stronger established generic presence in some markets
Ibuprofen	High-volume OTC and prescription NSAID	Pediatric, liquid, softgel, modified release	Intense competition
Naproxen	High-volume prescription and OTC NSAID	Delayed release, suspension, combination products	Crowded market
Diclofenac	Broad global use	Enteric, topical, extended release	Significant generic competition and safety scrutiny
Celecoxib	COX-2 selective NSAID	Capsule and specialty formulations	Higher value but stronger regulatory and market competition

Meclofenamate sodium is unlikely to win on price against high-volume NSAIDs. It can compete where prescribers specifically prefer fenamates, where supply is unreliable, or where a differentiated dosage form solves a documented administration problem.

What are the manufacturing and intellectual-property barriers?

The main manufacturing barriers are technical rather than legal. They include:

• API particle-size variability.
• Static and poor powder flow.
• Segregation during hopper transfer.
• Capsule-fill weight variation.
• Lubrication-related dissolution slowing.
• Moisture-driven degradation or capsule-shell changes.
• Cross-contamination controls in shared facilities.
• Reliable sourcing of API meeting identity, purity, and impurity specifications.

The strongest defensible assets are likely to be proprietary process parameters, validated supplier networks, analytical methods, and stability data. A narrow formulation patent may complement those assets, but it is unlikely to create broad market exclusivity.

What is the revenue exposure and launch outlook?

Meclofenamate sodium should be modeled as a low- to moderate-volume generic unless a sponsor identifies a clear supply shortage, institutional contract, or regional pricing advantage. Revenue exposure is more sensitive to unit volume and channel access than to premium pricing.

A practical launch model should include:

• 50 mg and 100 mg capsule demand.
• Hospital, retail, and institutional channel mix.
• API cost and minimum order quantity.
• Capsule-shell and excipient costs.
• Bioequivalence and stability-study expenses.
• Regulatory fees by country.
• Expected wholesaler discounts.
• Inventory required for intermittent demand.
• Price erosion from additional generic entrants.
• Product-liability and NSAID labeling controls.

The base case is a low-cost immediate-release capsule supported by manufacturing reliability. The upside case is a differentiated formulation with evidence of improved adherence, stability, or supply performance. The downside case is an approved product with insufficient demand to support commercial-scale manufacturing.

Key Takeaways

• Meclofenamate sodium is a mature oral NSAID with no meaningful new-chemical-entity exclusivity remaining.
• The core formulation opportunity is an immediate-release capsule using widely accepted excipients.
• Microcrystalline cellulose, a superdisintegrant, colloidal silicon dioxide, and a controlled lubricant system are practical starting points.
• Excipient selection should focus on content uniformity, dissolution, stability, and manufacturing yield.
• Biosimilar risk does not apply because the product is a small molecule.
• Patent value is more likely to arise from modified release, particle engineering, process control, or combination therapy than from the basic capsule.
• Commercial success depends on reliable supply, regional demand, and disciplined cost control.
• The most credible opportunity is a focused generic or lifecycle product, not a broad premium-priced NSAID platform.

FAQs

Is meclofenamate sodium the same as mefenamic acid?

No. They are related fenamate NSAIDs but are different active ingredients with different regulatory identities, specifications, and dosage-form requirements.

Can meclofenamate sodium be formulated as a tablet?

Yes. A tablet, including an immediate-release or modified-release tablet, is technically possible. The product would require formulation development, comparative dissolution, stability data, and the applicable bioequivalence or clinical evidence.

Which excipient is most important for meclofenamate sodium dissolution?

No single excipient controls dissolution in every formulation. Disintegrant selection, particle size, wetting, lubricant level, and granulation method collectively determine release performance.

Is a liquid meclofenamate sodium product commercially attractive?

A liquid could address patients who cannot swallow capsules, but it would create additional palatability, chemical stability, preservative, microbial-control, and dosing-accuracy requirements. The opportunity is stronger in markets with pediatric or geriatric demand.

Can a manufacturer obtain new exclusivity for a meclofenamate sodium formulation?

Potentially, but only a qualifying new formulation, dosage form, indication, or delivery technology can support meaningful exclusivity. Routine substitution of common excipients generally provides weak patent protection and limited market differentiation.

References

1. DailyMed. (n.d.). Meclofenamate sodium capsule prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (2014). Changes to an approved NDA or ANDA: Guidance for industry. https://www.fda.gov/

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugsatfda

4. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

5. U.S. Food and Drug Administration. (2022). Applications covered by section 505(b)(2): Guidance for industry. https://www.fda.gov/