List of Excipients in Branded Drug ADVIL MENSTRUAL PAIN

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Haleon US Holdings LLC	ADVIL MENSTRUAL PAIN	ibuprofen sodium	0573-0230	ACESULFAME POTASSIUM
Haleon US Holdings LLC	ADVIL MENSTRUAL PAIN	ibuprofen sodium	0573-0230	CARNAUBA WAX
Haleon US Holdings LLC	ADVIL MENSTRUAL PAIN	ibuprofen sodium	0573-0230	CELLULOSE, MICROCRYSTALLINE
Haleon US Holdings LLC	ADVIL MENSTRUAL PAIN	ibuprofen sodium	0573-0230	COPOVIDONE K25-31
Haleon US Holdings LLC	ADVIL MENSTRUAL PAIN	ibuprofen sodium	0573-0230	FERRIC OXIDE RED

Advil Menstrual Pain Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

Advil Menstrual Pain is a U.S. OTC combination product containing ibuprofen 200 mg and caffeine 60 mg per caplet. Its commercial position depends less on novel active-ingredient protection than on formulation execution, brand recognition, dosing convenience, regulatory compliance, and retailer access. The strongest excipient opportunities are improved disintegration, tablet robustness, coating performance, caffeine compatibility, and differentiated delivery formats.

What is the formulation of Advil Menstrual Pain?

The U.S. product is labeled as a coated caplet containing ibuprofen and caffeine. Haleon markets Advil, while the product labeling identifies the active ingredients as ibuprofen 200 mg and caffeine 60 mg per caplet.[1]

Attribute	Advil Menstrual Pain, U.S. product
Brand owner	Haleon
Dosage form	Oral coated caplet
Ibuprofen strength	200 mg
Caffeine strength	60 mg
Indication	Temporary relief of menstrual cramps and associated pain
Regulatory category	OTC analgesic combination
Primary market	United States
Biosimilar exposure	None
Orange Book relevance	Generally limited for an OTC monograph product

The product combines a nonsteroidal anti-inflammatory drug with caffeine. Ibuprofen provides analgesic and anti-inflammatory activity. Caffeine is used in combination analgesics and may contribute to analgesic efficacy, although its presence creates additional formulation, labeling, tolerability, and consumer-positioning considerations.

What excipients are disclosed for the product?

The product label identifies inactive ingredients that are typical for an immediate-release coated tablet. Public labeling has identified excipient classes including:

• Microcrystalline cellulose
• Croscarmellose sodium
• Starch
• Povidone
• Colloidal silicon dioxide
• Magnesium stearate
• Stearic acid
• Sodium lauryl sulfate
• Hypromellose
• Polyethylene glycol
• Lactose monohydrate
• Titanium dioxide

The precise quantitative composition, granulation process, particle-size specifications, coating parameters, and manufacturing controls are not generally disclosed on the consumer label. Those process variables may have greater commercial importance than the identity of the excipients alone.

How does the excipient system support product performance?

The formulation must reconcile four technical requirements: rapid release, mechanical strength, chemical stability, and acceptable consumer experience.

Immediate-release performance

Ibuprofen is a relatively high-dose active ingredient in the product. The excipient system must support rapid disintegration without producing excessive friability or capping during high-speed tableting.

Croscarmellose sodium, starch, and the tablet's pore structure can support caplet breakup. Microcrystalline cellulose contributes compressibility and mechanical integrity. Povidone may function as a binder, but excessive binder concentration can delay disintegration.

A reformulated product could target:

• Faster disintegration after gastric exposure
• More consistent dissolution across manufacturing lots
• Lower sensitivity to compression force
• Reduced tablet weight
• Improved performance after exposure to humidity

Caffeine distribution and content uniformity

Caffeine represents approximately 23% of the combined active load by weight. Uniform distribution is therefore important, particularly if ibuprofen and caffeine are introduced through separate powders or granulation steps.

Commercially relevant controls include:

• Caffeine particle-size distribution
• Blend uniformity
• Segregation control during transfer and compression
• Assay uniformity across the batch
• Control of caffeine migration during wet processing
• Monitoring of caffeine-related odor or taste after coating damage

Direct compression may reduce processing steps but can increase segregation risk if the active ingredients and excipients have materially different densities or particle sizes. A dry-granulation process may improve flow and content uniformity while limiting water exposure.

Coating and consumer acceptability

A film coat can reduce the bitter or stimulant-associated taste of caffeine and improve swallowability. It also protects the tablet from abrasion, light, and humidity.

The coating system can be optimized for:

• Lower coating weight
• Faster dissolution
• Reduced cracking and chipping
• Improved color uniformity
• Lower titanium dioxide dependence
• Compatibility with transparent or low-opacity coatings
• Better visual differentiation from standard Advil products

A thin, robust coating may reduce unit manufacturing cost while preserving appearance. A taste-masking coating could support chewable or orally disintegrating formats, although that would require a substantially different product design.

What formulation patents could protect an Advil Menstrual Pain competitor?

The active ingredients, ibuprofen and caffeine, are long-established compounds. Basic composition-of-matter patents do not provide a meaningful barrier for a new OTC competitor.

Potential protection would instead focus on formulation and manufacturing claims, including:

Potential claim area	Commercial value	Main limitation
Ibuprofen-caffeine ratio	Moderate	Prior-art risk is high
Rapid-release tablet	Moderate	Must demonstrate a meaningful performance difference
Specific disintegrant or binder system	Low to moderate	Easy design-around
Moisture-resistant formulation	Moderate	Requires stability data
Taste-masked caffeine dosage form	Moderate to high	More relevant to new formats
Modified-release menstrual-pain product	High if clinically useful	May change regulatory and clinical requirements
Combination product with additional menstrual-pain active	High	Greater regulatory and safety complexity
Manufacturing process with improved uniformity	Moderate	Protection may be narrow
Packaging that limits humidity or dose errors	Low to moderate	Often easier to replicate

A competitor may seek patent protection for a specific excipient ratio, dissolution profile, particle engineering method, coating architecture, or process sequence. Such patents would need to withstand obviousness challenges because ibuprofen tablets, caffeine combinations, immediate-release disintegrants, and film coatings are established technologies.

What is the Orange Book status of Advil Menstrual Pain?

Advil Menstrual Pain is an OTC product rather than a conventional prescription product approved through an NDA. FDA Orange Book listing is therefore not the principal source of commercial exclusivity for the product.[2]

The relevant regulatory framework is the FDA OTC system, including applicable analgesic labeling and monograph requirements. A generic or private-label manufacturer may pursue an OTC monograph-compliant product without relying on an NDA-sponsored approval pathway, provided the product meets applicable requirements.

This structure changes the competitive analysis:

• There is no conventional NDA exclusivity period comparable to prescription drugs.
• Paragraph IV litigation is generally not the primary entry mechanism.
• Competitors can enter through monograph compliance, private-label development, or other applicable OTC pathways.
• Brand equity, retailer placement, formulation quality, and advertising become central barriers.

When does Advil Menstrual Pain lose exclusivity?

Advil Menstrual Pain does not have a single patent-expiration date that controls market entry in the same manner as a patented prescription product.

The commercial exclusivity profile is driven by:

1. The absence or expiration of any product-specific formulation patents.
2. OTC monograph compliance.
3. Trademark protection for the Advil brand.
4. Trade dress and packaging differentiation.
5. Manufacturing know-how and supplier relationships.
6. Retailer contracts and advertising investment.

The active ingredients are established. A competing manufacturer can generally target the same ibuprofen-caffeine combination, subject to FDA requirements, labeling rules, quality standards, and applicable intellectual-property restrictions.

Are there Paragraph IV challenges, patent litigation, or settlement agreements?

No conventional Paragraph IV pathway is central to the U.S. Advil Menstrual Pain product because the product is marketed as an OTC combination rather than as a prescription NDA product.

A product-specific patent challenge could still arise if a manufacturer asserted a formulation, process, packaging, or use patent. That would be separate from the standard ANDA Paragraph IV model.

The available product-level regulatory sources do not establish a current, controlling patent litigation or settlement agreement that determines entry for Advil Menstrual Pain. Trademark disputes, advertising disputes, consumer class actions, and general NSAID litigation should be analyzed separately from formulation-patent litigation.

What generic and private-label launch risks exist?

The entry risk is high because the product has a familiar active-ingredient profile and does not depend on a complex delivery system.

Likely launch pathways

A competitor could commercialize:

• Ibuprofen 200 mg and caffeine 60 mg caplets
• A lower-cost store-brand equivalent
• A menstrual-pain product with ibuprofen alone
• A caffeine-free menstrual-pain product
• A softgel product containing ibuprofen
• A liquid-filled capsule
• A smaller or easier-to-swallow tablet
• A multipack with menstrual-health positioning

The strongest competitor may not need an exact copy. A retailer can use a private-label ibuprofen menstrual-pain product with similar labeling and a lower price.

Key barriers to entry

The main barriers are operational rather than patent-based:

• Consistent content uniformity for two active ingredients
• Tablet compression and coating capability
• Stability under heat and humidity
• Compliance with OTC labeling requirements
• Supply of pharmaceutical-grade ibuprofen and caffeine
• Retailer qualification
• Consumer trust in a menstrual-health indication
• Advertising and shelf-placement costs

What excipient strategies create commercial opportunities?

1. Faster-onset positioning

A highly porous tablet, optimized disintegrant system, or liquid-filled capsule could support a faster in-vitro dissolution profile. Any speed claim would require appropriate substantiation and careful FDA-compliant labeling.

The commercial opportunity is strongest where consumers associate menstrual cramps with a need for rapid relief. A faster-dissolving product could command a premium over standard caplets if the consumer benefit is credible.

2. Softgel or liquid-filled capsule

A liquid-filled ibuprofen-caffeine capsule could improve swallowability and offer a premium dosage form. The principal technical risks are caffeine solubility, compatibility with the fill vehicle, shell migration, leakage, and long-term stability.

Potential excipients include polyethylene glycol vehicles, surfactants, solubilizers, antioxidants, and shell plasticizers. The formulation must control caffeine precipitation and ibuprofen crystallization.

3. Low-lactose or lactose-free product

If the existing product uses lactose monohydrate, a reformulation could use mannitol, dibasic calcium phosphate, pregelatinized starch, or alternative grades of microcrystalline cellulose. A lactose-free positioning could expand consumer acceptance and simplify retailer portfolio segmentation.

The opportunity is commercially useful but unlikely to create strong patent protection by itself.

4. Reduced-coating or titanium-dioxide-free caplet

A simplified coating can lower material use and support clean-label or sustainability claims. Hydroxypropyl methylcellulose, polyethylene glycol, mineral pigments, iron oxides, or alternative opacifiers may be evaluated.

The formulation team must preserve color consistency, moisture protection, dissolution, and resistance to abrasion. A coating change also requires manufacturing validation and stability data.

5. Caffeine-tolerability positioning

Caffeine can be commercially useful but may discourage consumers who are sensitive to stimulants or who take the product at night. A brand architecture could include:

• Ibuprofen plus caffeine for daytime menstrual pain
• Ibuprofen-only nighttime or caffeine-free use
• Lower-caffeine formulations
• Separate products for cramp relief and premenstrual symptoms

This strategy expands the category but may reduce the simplicity of a single flagship SKU.

6. Pediatric and adolescent dosage formats

Menstrual-pain products are relevant to adolescents, but dosing, swallowing ability, caregiver use, and labeling require careful treatment. Liquid, chewable, mini-tablet, or lower-strength formats could address this segment.

Caffeine creates an added consumer and regulatory sensitivity in younger populations. A caffeine-free formulation may be commercially more appropriate for adolescent positioning.

How does Advil Menstrual Pain compare with competing products?

Product strategy	Active profile	Excipient opportunity	Competitive position
Advil Menstrual Pain	Ibuprofen plus caffeine	Immediate-release coated caplet	Branded combination product
Standard ibuprofen	Ibuprofen alone	Broadest formulation flexibility	Lower complexity and lower potential differentiation
Naproxen menstrual product	Naproxen	Longer-duration tablet or caplet	Different dosing profile
Acetaminophen menstrual product	Acetaminophen, sometimes with caffeine	Lower NSAID-related positioning	Different safety and efficacy profile
Ibuprofen softgel	Ibuprofen in liquid fill	Solubilization and shell stability	Premium dosage form
Store-brand combination	Ibuprofen plus caffeine	Cost-focused excipient system	Direct price competition

The most direct competitor is a store-brand product containing the same active ingredients and strength. A softgel or rapid-release dosage form is a more defensible commercial alternative than a simple excipient substitution.

What manufacturing and geographic IP barriers apply?

The formulation is relatively portable across manufacturing sites. Geographic barriers are more likely to involve:

• Country-specific OTC monographs
• Permitted caffeine labeling
• Excipient acceptance standards
• Maximum daily-dose rules
• Required menstrual-pain claims
• Trademark rights
• Packaging and language requirements
• Local registration or notification procedures

A U.S. formulation cannot be assumed to transfer directly to Canada, the European Union, the United Kingdom, Australia, or emerging markets. Caffeine status, analgesic monographs, warning language, and combination-product requirements differ by jurisdiction.

Manufacturing know-how may provide practical protection through blend uniformity, coating efficiency, stability control, and validated scale-up. That protection is difficult to enforce as an IP right but can reduce quality failures and accelerate retailer approval.

What is the revenue exposure and commercial opportunity?

Haleon reports Advil within its broader pain-relief portfolio rather than disclosing standalone revenue for Advil Menstrual Pain.[3] Product-level revenue therefore cannot be isolated reliably from public company reporting.

The commercial opportunity is concentrated in five areas:

1. Premium dosage forms, particularly softgels and rapid-release products.
2. Private-label supply for retailers.
3. Caffeine-free and nighttime menstrual-pain products.
4. Adolescent-friendly dosage forms.
5. International adaptation of the ibuprofen menstrual-pain platform.

The principal downside risk is rapid commoditization. Once a private-label manufacturer matches the active ingredients, strength, dosage form, and labeling, excipient differences alone may not justify a substantial price premium.

How strong is the patent estate for Advil Menstrual Pain?

The patent estate is likely weak at the active-ingredient level and moderate at the formulation and process level.

Estate component	Relative strength
Ibuprofen composition of matter	Very low
Caffeine composition of matter	Very low
Basic ibuprofen-caffeine combination	Low
Conventional immediate-release tablet	Low
Specific rapid-release formulation	Moderate
Softgel or liquid-fill formulation	Moderate
Manufacturing process	Moderate if technically narrow
Brand and trade dress	Potentially stronger than formulation IP
Retail distribution and consumer recognition	Commercially important but not patent protection

The best patent opportunity is a formulation that demonstrates a measurable technical effect, such as improved dissolution under defined conditions, better stability under accelerated humidity, reduced caffeine taste, or improved content uniformity. Broad claims covering routine excipient substitutions would face substantial validity and design-around risk.

Key Takeaways

• Advil Menstrual Pain is a U.S. OTC ibuprofen-caffeine product containing 200 mg of ibuprofen and 60 mg of caffeine per caplet.
• The formulation relies on conventional immediate-release tablet and film-coating excipients.
• Product-level exclusivity is driven more by trademark, brand, retailer access, and manufacturing controls than by active-ingredient patents.
• Paragraph IV litigation and Orange Book exclusivity are not the central entry issues for this OTC product.
• The highest-value formulation opportunities are rapid-release caplets, softgels, caffeine-tolerability variants, lactose-free products, and adolescent-friendly dosage forms.
• Generic and private-label entry risk is high because the active ingredients are established and the product does not require a complex delivery platform.
• Stronger formulation patents would require a specific, non-obvious excipient architecture or manufacturing process supported by comparative performance data.
• Public financial reporting does not isolate Advil Menstrual Pain revenue from Haleon's broader Advil portfolio.

FAQs

Can a competitor legally copy the Advil Menstrual Pain excipients?

A competitor may use the same excipients if the formulation does not infringe an enforceable patent, trademark, trade dress right, or other protected claim. Excipients themselves generally do not create exclusivity.

Is caffeine necessary for a menstrual-pain product?

No. Caffeine is a formulation and labeling choice. A competitor can develop an ibuprofen-only product, although it would occupy a different commercial position from the ibuprofen-caffeine combination.

What is the best excipient for faster ibuprofen tablet disintegration?

No single excipient determines performance. Croscarmellose sodium, starch, tablet porosity, compression force, particle size, and lubricant level must be optimized as a system.

Could Advil Menstrual Pain be reformulated as an orally disintegrating tablet?

Yes, but caffeine taste, ibuprofen dose, tablet size, moisture sensitivity, and consumer acceptability make the format technically more difficult than a standard coated caplet.

Does Advil Menstrual Pain have biosimilar competition?

No. Biosimilar regulation applies to biological products. Advil Menstrual Pain contains small-molecule active ingredients and faces generic and private-label competition instead.

References

1. DailyMed. (n.d.). Advil menstrual pain relief: Ibuprofen and caffeine tablet, film coated. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (n.d.). 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

3. Haleon plc. (2024). Annual report and accounts 2023. https://www.haleon.com/investors/annual-reports

4. U.S. Food and Drug Administration. (n.d.). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/sda/sdNavigable.cfm?sd=inactiveIngredientDatabase

5. U.S. Food and Drug Administration. (n.d.). OTC monograph M012: Internal analgesic, antipyretic, and antirheumatic drug products. https://www.accessdata.fda.gov/