List of Excipients in Branded Drug GOOD SENSE NAPROXEN SODIUM

Generic Drugs Containing GOOD SENSE NAPROXEN SODIUM

Company	Ingredient	NDC	Excipient
L Perrigo Company	naproxen sodium	0113-0901	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	naproxen sodium	0113-0901	FD&C BLUE NO. 2 ALUMINUM LAKE
L Perrigo Company	naproxen sodium	0113-0901	HYPROMELLOSE
L Perrigo Company	naproxen sodium	0113-0901	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in GOOD SENSE NAPROXEN SODIUM?

# Of NDCs	Excipient
10	CELLULOSE, MICROCRYSTALLINE
1	CROSCARMELLOSE SODIUM
1	FD&C BLUE NO. 1 ALUMINUM LAKE
6	FD&C BLUE NO. 2

GoodSense Naproxen Sodium Excipient Strategy and Commercial Opportunities

Last updated: August 3, 2026

GoodSense Naproxen Sodium is an OTC immediate-release naproxen sodium product, typically marketed as 220 mg tablets for temporary relief of minor aches and pains. Its commercial position depends less on novel active-ingredient protection and more on low-cost tablet manufacture, stable supply, compliant Drug Facts labeling, retailer access, and differentiated packaging or dosage-form extensions.

The product is regulated through the FDA OTC analgesic framework rather than a conventional prescription-drug exclusivity model. Its core excipient strategy is built around tablet manufacturability, rapid disintegration, acceptable mouthfeel, coating performance, and low unit cost. The strongest commercial opportunities are private-label expansion, value-pack formats, e-commerce packaging, travel sizes, and differentiated formulations that remain within the applicable OTC regulatory pathway.

What is GoodSense Naproxen Sodium?

GoodSense Naproxen Sodium contains naproxen sodium, an NSAID used for temporary relief of minor aches and pains associated with arthritis, muscular aches, backache, headache, toothache, menstrual cramps, common cold, and minor pain of the muscles and joints. The standard OTC strength is 220 mg naproxen sodium per tablet, equivalent to approximately 200 mg naproxen.[1]

Product attribute	Commercial description
Brand	GoodSense
Active ingredient	Naproxen sodium
Typical strength	220 mg per tablet
Dosage form	Immediate-release tablet
Regulatory category	OTC analgesic, antipyretic, and antirheumatic product
Principal use	Temporary relief of minor aches and pains
Primary channels	Retail pharmacy, mass retail, club, grocery, and e-commerce
Primary competitors	Aleve, generic naproxen sodium, store-brand NSAID products
Biosimilar exposure	None
Orange Book relevance	Limited for an OTC monograph product

The product’s value proposition is a lower-priced alternative to branded Aleve while using the same active ingredient and standard OTC dosing framework.

What excipients are used in GoodSense Naproxen Sodium tablets?

Public labels for GoodSense and comparable naproxen sodium 220 mg tablets identify conventional solid-dose excipients used for direct compression or wet granulation, tablet disintegration, lubrication, film coating, and appearance control. The precise inactive-ingredient list can vary by manufacturer, NDC, tablet imprint, and packaging configuration.

Typical excipient categories include:

Excipient category	Common examples	Function
Diluent or filler	Microcrystalline cellulose	Adds bulk and improves tablet compression
Binder	Povidone	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium	Promotes tablet breakup after ingestion
Lubricant	Magnesium stearate	Reduces tooling friction and ejection force
Glidant	Colloidal silicon dioxide	Improves powder flow and blend uniformity
Coating polymer	Polyvinyl alcohol or related film former	Provides smooth surface and handling protection
Plasticizer	Polyethylene glycol	Improves coating flexibility
Opacifier or colorant	Titanium dioxide or approved colorants	Controls appearance and light protection
Anti-adherent	Talc	Reduces sticking during compression or coating

The most commercially important excipient functions are disintegration and manufacturability. Naproxen sodium is more water-soluble than naproxen, but dissolution performance still depends on particle size, blend uniformity, compression force, tablet porosity, and disintegrant distribution.

How does the excipient strategy affect product performance?

The excipient system must balance four operating requirements: fast release, adequate mechanical strength, low defect rates, and low cost.

Disintegration and dissolution

Croscarmellose sodium or another superdisintegrant allows the tablet to break apart rapidly after contact with gastrointestinal fluid. Excessive compression can reduce tablet porosity and delay disintegration. Insufficient compression can produce friability, edge chipping, and packaging losses.

For a standard immediate-release product, the formulation objective is not sustained release. The commercial target is consistent disintegration and dissolution within the applicable FDA and USP expectations while maintaining tablet robustness during high-volume distribution.

Tablet compression

Microcrystalline cellulose and povidone support tablet tensile strength. The formulation must tolerate variation in raw-material moisture, particle-size distribution, and lubricant mixing time. Over-lubrication with magnesium stearate can reduce tablet hardness and slow wetting or dissolution.

A robust formulation therefore requires control of:

• Blend uniformity
• Lubrication time
• Compression force
• Tablet hardness
• Friability
• Weight variation
• Disintegration time
• Dissolution profile
• Coating weight gain

Coating and consumer acceptance

Film coating improves swallowability, protects the tablet surface, limits powdering, and permits color or imprint differentiation. Coating also creates an opportunity to reduce visual similarity with competing products and strengthen retailer-specific branding.

Coating materials must be selected with attention to:

• Moisture permeability
• Coating adhesion
• Color consistency
• Printing and imprint legibility
• Mechanical resistance during bottle filling
• Compatibility with HDPE bottles, blister packs, and unit-dose pouches

What formulation patents protect GoodSense Naproxen Sodium?

The principal GoodSense product does not depend on a novel naproxen molecule or a complex delivery technology. Naproxen and naproxen sodium have long-established pharmaceutical use. The relevant intellectual-property risks are more likely to involve formulation patents, packaging technology, manufacturing processes, trademarks, and supplier know-how than basic active-ingredient rights.

IP category	Relevance to GoodSense
Naproxen compound patent	Generally expired or commercially immaterial
Naproxen sodium composition patent	Low risk for a conventional OTC tablet
Immediate-release tablet formulation	Potentially relevant if a third party claims a specific excipient ratio or process
Enteric or delayed-release formulation	Relevant only to a differentiated dosage form
Liqui-gel or softgel delivery system	Potentially relevant to competing products
Packaging patent	Relevant to child-resistant, unit-dose, or dispensing systems
Trademark rights	Relevant to GoodSense branding and retailer distribution
Manufacturing know-how	Important for yield, dissolution, coating, and stability
Orange Book-listed patents	Generally not central to the monograph product

A supplier entering the market should conduct a current patent and trademark review covering naproxen sodium tablets, softgels, liquids, dispersible products, and packaging systems. The greater practical barrier is often qualification of an approved manufacturing site and successful retailer onboarding.

What is the FDA regulatory status of GoodSense Naproxen Sodium?

Naproxen sodium 220 mg products are generally marketed under the FDA OTC monograph framework for internal analgesic, antipyretic, and antirheumatic products. The applicable requirements include active-ingredient eligibility, dosage limits, warnings, directions, labeling, and packaging controls.[2]

The product must comply with the current Drug Facts format and NSAID warning requirements. Label controls are commercially important because naproxen sodium is associated with gastrointestinal bleeding, cardiovascular risk, allergic reactions, and interactions with other NSAIDs or anticoagulants.

Key regulatory requirements include:

• Correct active-ingredient declaration
• Appropriate age restrictions
• Maximum daily dose and dosing interval
• Warning against concurrent use with other naproxen or NSAID products
• Pregnancy and bleeding-risk warnings where required
• Child-resistant packaging where applicable
• Stability through labeled shelf life
• Current FDA OTC labeling requirements
• Compliance with current good manufacturing practice

What is the Orange Book status of GoodSense Naproxen Sodium?

GoodSense Naproxen Sodium is generally not dependent on an Orange Book-listed patent estate in the manner of a prescription NDA product. OTC monograph marketing does not normally require an innovator NDA with listed patents supporting a 30-month stay or Paragraph IV litigation strategy.

Exclusivity mechanism	Relevance
New chemical entity exclusivity	Not relevant
Five-year NDA exclusivity	Not relevant to a conventional OTC monograph product
Three-year clinical-investigation exclusivity	Not normally relevant
Pediatric exclusivity	Not central to the product
Orphan exclusivity	Not relevant
Paragraph IV certification	Generally not the standard route for a monograph OTC tablet
Orange Book patent listing	Limited or absent for the conventional product
OTC monograph compliance	Primary regulatory route

The commercial consequence is that generic and private-label competition can enter without waiting for expiration of a branded prescription-drug patent estate. Manufacturer qualification, product quality, supply reliability, and retailer contracts become the main entry filters.

When does GoodSense Naproxen Sodium lose exclusivity?

GoodSense Naproxen Sodium does not have a conventional patent-based exclusivity date that controls generic entry. The active ingredient is mature, and competing manufacturers can market compliant naproxen sodium products under the OTC monograph pathway.

Commercial protection may still arise from:

• GoodSense trademark rights
• Retailer-specific branding
• Private-label supply agreements
• Packaging designs
• Manufacturing economics
• Customer loyalty
• Shelf placement
• E-commerce search ranking
• Product reviews and repeat purchasing

These protections are contractual and commercial rather than statutory exclusivity rights.

What commercial opportunities exist for naproxen sodium excipient innovation?

Lower-cost conventional tablets

The largest opportunity remains cost reduction. A manufacturer can improve margins through higher tablet yield, lower coating weight, fewer process steps, and reduced reject rates. Excipient substitutions should preserve dissolution, hardness, friability, and stability.

Potential initiatives include:

• Direct-compression formulations
• Reduced lubricant levels
• Optimized superdisintegrant placement
• Lower-cost film-coating systems
• Domestic or dual-source excipient qualification
• Continuous blending and compression
• Reduced tablet weight
• High-speed bottle or blister filling

Smaller tablets

A smaller 220 mg tablet can improve swallowing and reduce packaging volume. The formulation challenge is maintaining adequate drug loading and mechanical strength without compromising disintegration.

Smaller tablets have commercial value in:

• Senior-care products
• Travel packs
• Convenience stores
• E-commerce multipacks
• Private-label pharmacy programs

Caplets and coated tablets

Caplets provide a recognizable OTC format and may improve swallowability. They also create room for a differentiated imprint, color, and packaging design. The excipient system must support uniform coating across the elongated geometry and prevent edge damage during filling.

Softgels and liquid-filled capsules

Softgels can compete directly with Aleve and other liquid-filled NSAID products. Their value proposition is easier swallowing and rapid dispersion of a liquid or semisolid fill. The regulatory and technical burden is higher than for conventional tablets because the manufacturer must control shell compatibility, fill viscosity, leakage, seam integrity, oxygen exposure, and long-term stability.

Softgel entry may provide more pricing differentiation, but it also creates greater manufacturing and IP exposure.

Blister and unit-dose packaging

Unit-dose packaging can support institutional sales, travel products, first-aid kits, and pharmacy adherence programs. Blisters can improve portability and dose visibility, but they usually have a higher packaging cost than bottles.

The main opportunities are:

• Calendar or time-of-use packs
• Child-resistant unit-dose designs
• Small travel packs
• Hospital and clinic dispensing
• E-commerce damage-resistant packs

Combination products

Combination products containing naproxen sodium with another analgesic or cold-treatment active could expand the addressable market, but they create more complex regulatory, labeling, interaction, and dosing issues. Combination products also face greater risk of therapeutic duplication and consumer misuse.

A lower-risk strategy is packaging-based differentiation rather than adding a second active ingredient.

How strong is the patent estate for GoodSense Naproxen Sodium?

The patent estate is weak as a barrier to conventional OTC tablet competition and stronger only where a company adds a proprietary delivery system, formulation, or packaging platform.

Product strategy	Patent barrier	Regulatory complexity	Commercial attractiveness
Standard 220 mg tablet	Low	Low to moderate	High volume, low margin
Smaller tablet	Low to moderate	Moderate	Moderate
Caplet	Low	Moderate	Moderate
Softgel	Moderate to high	Moderate to high	High differentiation
Enteric-coated tablet	Moderate	Moderate	Targeted opportunity
Extended-release product	High	High	Potentially higher margin
Combination product	Variable	High	Depends on indication
Unit-dose packaging	Moderate	Moderate	Strong institutional and travel use

The most defensible commercial innovation would combine a differentiated dosage form with manufacturing cost advantages. A purely conventional tablet is easier to launch but is exposed to rapid price competition.

Which companies are challenging GoodSense Naproxen Sodium?

Competition comes from branded, generic, and private-label manufacturers. The principal reference brand is Aleve, while store-brand products are sold through pharmacy, mass-retail, club, grocery, and online channels.

Competitive categories include:

• Aleve and other branded naproxen sodium products
• Retailer-owned store brands
• Generic OTC manufacturers
• Contract manufacturers supplying private labels
• Softgel and liquid-filled capsule suppliers
• Ibuprofen and acetaminophen manufacturers

The most important competitive comparison is not patent strength. It is the combination of retail price, count size, package format, brand recognition, and channel-specific availability.

What is the revenue exposure and market opportunity?

GoodSense revenue is not generally reported as a separately disclosed public product line. The economic model is therefore based on unit volume, net price, trade spending, and retailer terms rather than a published product-specific revenue figure.

A practical revenue model is:

Revenue = units sold x net realized price per unit

Profitability depends on:

• Active pharmaceutical ingredient cost
• Excipient and coating cost
• Conversion cost
• Packaging cost
• Freight and warehousing
• Retailer margin
• Promotional allowances
• Returns and chargebacks
• Quality and compliance costs

The conventional 220 mg tablet offers high-volume potential but limited per-unit pricing power. Softgels, travel packs, and specialized packaging can improve gross margin, although they require more capital and technical validation.

What manufacturing and IP barriers affect market entry?

The principal barriers are operational:

1. Qualification of a compliant OTC manufacturing site.
2. Reliable supply of naproxen sodium meeting pharmacopeial specifications.
3. Demonstrated blend uniformity and dissolution control.
4. Stability data for the selected bottle, blister, or pouch.
5. Packaging compliance and child-resistance testing.
6. Retailer audit approval.
7. Adequate product-liability controls.
8. Trademark clearance and private-label contracting.
9. Dual sourcing for critical excipients and packaging components.
10. Capacity to manage recalls, complaints, and adverse-event reporting.

For a conventional tablet, the formulation itself is unlikely to prevent entry. Process capability and customer access are more decisive.

What licensing deals affect GoodSense Naproxen Sodium?

The product is more likely to be commercialized through private-label manufacturing, distribution, and retailer supply agreements than through a public drug-licensing transaction. The key contractual issues are:

• Product ownership
• Regulatory responsibility
• Change-control approval
• Excipient and supplier substitutions
• Minimum order quantities
• Forecast commitments
• Recall allocation
• Pharmacovigilance obligations
• Exclusivity by channel or geography
• Packaging and trademark rights

A manufacturer with a validated naproxen sodium platform can pursue multiple retailer brands using a common core formulation while varying tablet appearance, count size, and packaging.

What generic launch scenarios exist for GoodSense Naproxen Sodium?

Base-case launch

A supplier launches a standard 220 mg immediate-release tablet under a retailer or pharmacy private label. The primary advantage is low cost and supply reliability. The principal risk is price compression.

Premium-format launch

A supplier launches coated caplets, softgels, or smaller tablets. This supports higher retail pricing but requires greater formulation, packaging, and manufacturing investment.

Institutional launch

A supplier targets hospitals, clinics, long-term-care facilities, and first-aid distributors with unit-dose blisters or high-count bottles. Procurement pricing is aggressive, but contracts can provide recurring volume.

E-commerce launch

A supplier uses multipacks, subscription purchasing, and compact packaging. E-commerce reduces dependence on shelf placement but increases the importance of search ranking, fulfillment reliability, package integrity, and review performance.

Key Takeaways

• GoodSense Naproxen Sodium is a mature OTC naproxen sodium 220 mg product with limited conventional patent protection.
• Its core excipient strategy centers on disintegration, compression performance, lubrication, coating, and stability.
• The main commercial advantage is low-cost substitution for Aleve and other branded naproxen sodium products.
• Patent-based exclusivity and Paragraph IV risk are generally limited for the conventional OTC monograph tablet.
• The strongest opportunities are private-label supply, smaller tablets, caplets, softgels, travel packs, unit-dose packaging, and e-commerce multipacks.
• Manufacturing scale, retailer access, quality systems, and supply contracts are more important entry barriers than active-ingredient patents.
• Formulation innovation can improve margin, but it must preserve immediate-release performance and OTC labeling compliance.

FAQs About GoodSense Naproxen Sodium Excipient and Commercial Strategy

Can GoodSense Naproxen Sodium use different excipients without changing the product’s commercial position?

Yes. Excipients can be changed if the finished product continues to meet applicable quality, stability, dissolution, labeling, and manufacturing requirements. Changes require documented formulation and process evaluation.

Is naproxen sodium more commercially attractive than naproxen?

Naproxen sodium is generally more suitable for immediate-release OTC products because its salt form improves water solubility relative to naproxen. The commercial advantage depends on dosage form, dissolution performance, and consumer positioning.

Are formulation patents likely to block a new 220 mg naproxen sodium tablet?

Usually not for a conventional immediate-release tablet. Risk increases for softgels, enteric-coated systems, extended-release products, proprietary excipient matrices, and specialized packaging.

Does a retailer need an NDA to sell a GoodSense-type naproxen sodium product?

A compliant OTC monograph product generally follows the monograph route rather than relying on a conventional prescription NDA. The responsible manufacturer must meet FDA requirements for formulation, manufacturing, labeling, packaging, and quality.

Which dosage form offers the best commercial margin?

Softgels and differentiated caplets may offer higher pricing than standard tablets, but they also have higher manufacturing and validation costs. Standard tablets usually offer the strongest volume economics.

References

1. U.S. Food and Drug Administration. (2024). DailyMed label: GoodSense naproxen sodium 220 mg tablet. National Library of Medicine.
2. U.S. Food and Drug Administration. (2024). OTC Monograph M005: Oral analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use.
3. U.S. Food and Drug Administration. (2024). Code of Federal Regulations, Title 21, Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use.
4. United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary: Naproxen sodium tablets and related general chapters.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.