List of Excipients in Branded Drug ADVIL PM

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Haleon US Holdings LLC	ADVIL PM	diphenhydramine citrate and ibuprofen	0573-0164	CALCIUM STEARATE
Haleon US Holdings LLC	ADVIL PM	diphenhydramine citrate and ibuprofen	0573-0164	CARNAUBA WAX
Haleon US Holdings LLC	ADVIL PM	diphenhydramine citrate and ibuprofen	0573-0164	CELLULOSE, MICROCRYSTALLINE

Advil PM Excipient Strategy and Commercial Opportunities

Last updated: August 15, 2026

Advil PM combines ibuprofen 200 mg with diphenhydramine citrate 38 mg, equivalent to 25 mg diphenhydramine, in an over-the-counter nighttime analgesic. Its commercial value depends less on active-ingredient exclusivity than on formulation reliability, dosage-form differentiation, brand recognition, packaging, and regulatory compliance. The most attractive excipient opportunities are rapid-disintegrating caplets, softgel systems, improved swallowability, moisture control, lower-cost film coatings, and differentiated nighttime delivery formats.

What is Advil PM and which active ingredients does it contain?

Advil PM is a fixed-dose combination product marketed for temporary relief of minor aches and pains while helping the consumer fall asleep. The core formulation contains:

Component	Amount per dosage unit	Function
Ibuprofen	200 mg	Analgesic and fever reducer
Diphenhydramine citrate	38 mg	Nighttime sleep-aid ingredient, equivalent to 25 mg diphenhydramine

The product is sold in multiple presentations, including coated caplets and Liqui-Gels. Exact excipients vary by dosage form, manufacturing site, and market. Public product labeling identifies excipient classes that can include microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, povidone, hypromellose, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, colorants, gelatin, mineral oil, lecithin, polyethylene glycol, sorbitol, and purified water, depending on the product presentation (DailyMed, n.d.-a; DailyMed, n.d.-b).

The formulation challenge is unusual because the product combines a poorly water-soluble nonsteroidal anti-inflammatory drug with a sedating antihistamine salt. The excipient system must support dose uniformity, disintegration, dissolution, physical stability, capsule integrity, and consumer acceptability.

What excipient functions are most important in Advil PM?

How do excipients support ibuprofen dissolution?

Ibuprofen has low aqueous solubility and can demonstrate dissolution sensitivity to particle size, wetting, compression force, lubricant concentration, and tablet porosity. A caplet formulation therefore benefits from:

• Microcrystalline cellulose for compactability and tablet structure.
• Pregelatinized starch for binding and disintegration.
• Croscarmellose sodium for rapid water uptake and breakup.
• Povidone for granule binding.
• Surfactants such as sodium lauryl sulfate to improve wetting.
• Controlled levels of stearic acid or other lubricants to prevent excessive hydrophobicity.

Excessive lubrication can slow dissolution. The manufacturing process must balance ejection force against wetting and release performance. This creates an opportunity for low-level, high-efficiency lubricants, co-processed excipients, and direct-compression systems that maintain dissolution at lower lubricant loading.

How do excipients manage diphenhydramine citrate?

Diphenhydramine citrate is more water-soluble than ibuprofen and can migrate during wet granulation or create localized concentration differences if the blend segregates. Excipient selection should control:

• Blend uniformity.
• Electrostatic behavior.
• Moisture exposure.
• Particle-size mismatch between active ingredients and fillers.
• Tablet weight variation.
• Taste and odor release if the dosage form is chewed or damaged.

A dry granulation or direct-compression process can reduce water-driven migration. Ordered mixing, engineered particle-size distribution, and low-segregation co-processed excipients may improve content uniformity while reducing manufacturing complexity.

Which excipients are relevant to softgel and Liqui-Gel products?

Softgel systems use a different excipient strategy from compressed caplets. Typical functions include:

• Mineral oil or another liquid vehicle for dispersing or suspending ibuprofen.
• Lecithin or related wetting agents.
• Gelatin for the shell.
• Sorbitol or glycerol as a plasticizer.
• Polyethylene glycol or related processing aids.
• Purified water for gelatin processing.
• Opacifiers and colorants for appearance and light protection.

Softgel development must control ibuprofen suspension stability, sedimentation, capsule-seam integrity, shell brittleness, oxygen exposure, and fill-weight uniformity. Diphenhydramine citrate may require a separate compatibility assessment because ionic or hygroscopic components can affect shell moisture and long-term stability.

What formulations are protected by Advil PM intellectual property?

Advil PM’s commercial protection is primarily based on the Advil brand, trade dress, distribution, consumer recognition, and manufacturing know-how. A current, enforceable composition-of-matter patent for the ibuprofen-diphenhydramine combination is not the principal market barrier.

The active ingredients are old, widely used OTC substances. The combination itself is vulnerable to private-label and store-brand competition when a competing product complies with applicable FDA requirements and avoids protected branding or proprietary presentation. Formulation patents, if any remain relevant to a specific product or manufacturing process, must be evaluated by product presentation, jurisdiction, assignee, claim scope, and legal status. No reliable commercial analysis should treat every historical patent publication as an active barrier.

Does Advil PM have Orange Book-listed patents?

Advil PM is generally positioned as an OTC product marketed under FDA OTC rules rather than as a conventional prescription NDA product with an Orange Book patent listing. The Orange Book is therefore not the primary source for Advil PM exclusivity analysis. FDA’s OTC monograph framework and product labeling are more relevant to market entry (FDA, n.d.-a; FDA, n.d.-b).

A compliant competitor does not normally face the same Paragraph IV certification process associated with an ANDA referencing a patent-listed prescription product. The absence of an Orange Book listing does not eliminate all intellectual-property risk. Trademark, trade dress, formulation, packaging, manufacturing, and litigation risks remain separate issues.

When does Advil PM lose exclusivity?

Advil PM has no conventional patent cliff comparable to a patented prescription medicine. Market exclusivity is already constrained by the age of ibuprofen and diphenhydramine and by the availability of competing nighttime analgesic products.

Protection category	Advil PM position	Commercial effect
Active-ingredient patent	Expired or commercially immaterial for these legacy ingredients	Does not block generic or private-label competition
FDA OTC exclusivity	No durable exclusivity comparable to a new prescription product	Competitors can enter if compliant
Orange Book listing	Not the central regulatory mechanism	Paragraph IV risk is limited
Trademark	Advil and Advil PM branding remain valuable	Prevents confusingly similar branding
Trade dress	Packaging and presentation may provide differentiation	Can support brand enforcement
Formulation know-how	Potentially important but often not publicly visible	May reduce cost or improve quality
Consumer franchise	Major practical barrier	Supports pricing and shelf placement

The product’s “exclusivity” is therefore continuous and commercial rather than patent-defined. The largest threat is substitution by store brands containing ibuprofen and diphenhydramine, not a single scheduled generic launch date.

Which companies are challenging Advil PM?

Private-label manufacturers, large generic companies, and consumer-health companies can compete with Advil PM through equivalent or similar nighttime analgesic products. The competitive set includes:

• Store-brand nighttime pain relievers.
• Generic ibuprofen and diphenhydramine combinations.
• Competing branded nighttime analgesics.
• Standalone ibuprofen and diphenhydramine products used together by consumers.
• Digital and retail health brands offering lower-priced combination products.

Publicly reported litigation specifically involving a Paragraph IV challenge to Advil PM is not the central market issue. The more relevant disputes would involve trademark infringement, false advertising, packaging similarity, product liability, manufacturing rights, or formulation claims.

What FDA regulatory status applies to Advil PM?

Ibuprofen and diphenhydramine are regulated as OTC active ingredients under FDA rules and applicable monograph requirements. A manufacturer seeking to market a competing product must satisfy requirements covering active ingredients, dosage, labeling, warnings, directions, quality, manufacturing, and permissible indications.

Relevant regulatory considerations include:

• Ibuprofen analgesic and antipyretic requirements under the OTC framework.
• Diphenhydramine nighttime sleep-aid requirements.
• Combination-product labeling and warnings.
• Maximum daily dosing and age restrictions.
• Sedation warnings associated with diphenhydramine.
• NSAID warnings, including gastrointestinal, cardiovascular, renal, and allergic risks.
• FDA current good manufacturing practice requirements.
• Excipient acceptability and use levels.

A reformulation that changes excipients without changing active ingredients may remain within the OTC pathway, but changes to dosage form, release behavior, claims, strength, or route of administration can create additional regulatory requirements. FDA’s Inactive Ingredient Database and relevant United States Pharmacopeia standards are important tools for formulation screening (FDA, n.d.-c; USP, n.d.).

What commercial opportunities exist for Advil PM excipients?

Can a faster-dissolving Advil PM formulation command a premium?

A rapid-disintegration caplet or softgel could support a “fast relief” positioning if dissolution, onset, and labeling claims are supported by appropriate evidence. The opportunity is strongest where the formulation improves ibuprofen wetting without compromising stability or increasing gastrointestinal exposure.

Potential technologies include:

• Co-processed microcrystalline cellulose and disintegrant systems.
• Surface-active excipient systems.
• Spray-dried ibuprofen dispersions.
• Amorphous or partially amorphous solid dispersions.
• Liquisolid or lipid-based delivery systems.
• Porous tablets with controlled compression force.

The commercial constraint is that faster dissolution does not automatically permit a faster-onset claim. The claim must be supported by the applicable regulatory and clinical evidence standard.

Is there an opportunity for smaller or easier-to-swallow dosage forms?

The combined active load is substantial for a single unit. A smaller caplet, mini-tablet format, or two-unit dose could improve swallowing for older adults and consumers with dysphagia. Excipient suppliers could target high-density fillers, superior compactability, and low-weight film-coating systems.

Potential benefits include:

• Lower tablet volume.
• Reduced chalkiness.
• Better coating coverage.
• More consistent breaking strength.
• Improved manufacturability on high-speed presses.

The main risk is that reducing tablet size can increase compression force and slow disintegration. The excipient system must preserve both mechanical strength and release performance.

Can Advil PM be reformulated for consumer-health preferences?

Potential line extensions include:

Opportunity	Excipient strategy	Key constraint
Sugar-free softgel	Non-sugar plasticizer and shell system	Shell strength and moisture migration
Vegan or non-gelatin capsule	HPMC or other plant-derived shell	Oxygen, sealing, and process compatibility
Gluten-free caplet	Controlled excipient sourcing and supplier qualification	Cross-contamination controls
Dye-free product	Opacifier and appearance redesign	Consumer acceptance
Smaller caplet	High-functionality filler and disintegrant	Dissolution after compression
Unit-dose blister	Low-moisture packaging and barrier films	Cost and recyclability
Pediatric-adjacent format	Alternative dosage form and lower strength	Diphenhydramine safety and labeling restrictions

A vegan or gelatin-free format may create meaningful differentiation, but it is more technically demanding than a simple excipient substitution. The shell must meet mechanical, sealing, dissolution, and stability requirements across temperature and humidity conditions.

What manufacturing and IP barriers affect Advil PM competitors?

The active ingredients are readily available, so manufacturing access is not the main barrier. The difficult elements are process control and product consistency.

Key barriers include:

1. Uniform distribution of ibuprofen and diphenhydramine citrate.
2. Control of ibuprofen dissolution after lubrication and compression.
3. Softgel suspension stability.
4. Capsule-shell moisture management.
5. Long-term color and appearance stability.
6. High-speed filling and sealing performance.
7. Packaging that protects against moisture and oxygen.
8. Compliance with combination-product labeling requirements.
9. Avoidance of Advil trade dress and confusingly similar packaging.

A competitor can often match the active ingredients but still fail to match Advil PM on dissolution, capsule integrity, shelf life, consumer experience, or retail execution.

How strong is the Advil PM patent estate?

The estate is strategically stronger as a brand and manufacturing platform than as a blocking patent portfolio. Legacy active ingredients do not provide meaningful exclusivity. Any potentially relevant formulation or process patents should be screened for:

• Expired, lapsed, abandoned, or granted status.
• Claim coverage of the exact dosage form.
• Continuing-term and terminal-disclaimer issues.
• Geographic enforceability.
• Ownership and assignment history.
• Actual commercial use.
• Design-around options.

For private-label entrants, the practical freedom-to-operate analysis should focus on formulation and packaging patents, trademarks, trade dress, and manufacturing agreements rather than relying solely on Orange Book data.

What revenue exposure does Advil PM create for Haleon?

Haleon does not generally disclose Advil PM revenue as a standalone public reporting line. Revenue exposure is therefore assessed through the broader Advil franchise and the U.S. consumer-health portfolio rather than through a separately reported product figure (Haleon plc, 2024).

The largest commercial sensitivities are:

• Store-brand price competition.
• Retailer shelf-space decisions.
• Seasonal demand for nighttime pain relief.
• Consumer switching between caplets and Liqui-Gels.
• Regulatory changes affecting diphenhydramine labeling.
• Product-liability and NSAID safety concerns.
• Input costs for gelatin, specialty polymers, oils, coatings, and packaging.

Excipient cost is unlikely to be the dominant value driver per unit. The larger opportunity is using excipients to improve product performance, reduce manufacturing losses, enable a new format, or support a premium consumer claim.

What generic launch scenarios exist for Advil PM?

Scenario 1: Direct private-label substitution

A retailer launches a caplet containing the same active ingredients and comparable labeling. This is the lowest technical-risk scenario and puts pressure on price, promotions, and shelf placement.

Scenario 2: Softgel or Liqui-Gel competition

A competitor uses a softgel dosage form to position the product around swallowability or rapid release. This raises manufacturing and stability requirements but can create more direct competition with Advil PM Liqui-Gels.

Scenario 3: Differentiated excipient platform

A competitor launches a dye-free, gelatin-free, smaller, or faster-disintegrating product. The formulation may command a premium if the consumer benefit is clear and legally supportable.

Scenario 4: Separate-product substitution

Consumers purchase ibuprofen and diphenhydramine separately. This reduces the need for a fixed-dose combination and can increase pharmacist or consumer control over dosing, although it reduces convenience.

Key Takeaways

• Advil PM contains ibuprofen 200 mg and diphenhydramine citrate 38 mg per dosage unit.
• The principal commercial opportunity is formulation differentiation, not active-ingredient exclusivity.
• Excipient priorities are dissolution enhancement, blend uniformity, rapid disintegration, softgel stability, and improved swallowability.
• Advil PM is primarily protected by brand equity, trade dress, manufacturing know-how, and distribution.
• Orange Book patents and Paragraph IV litigation are not the central entry barriers for this OTC product.
• Private-label products can compete if they meet FDA requirements and avoid Haleon’s trademarks and trade dress.
• The strongest product-development opportunities are smaller caplets, improved Liqui-Gel systems, dye-free or gelatin-free formats, and moisture-protective packaging.
• Revenue exposure is tied to the broader Advil franchise because standalone Advil PM sales are not generally disclosed.

FAQs

Does Advil PM use the same excipients in caplets and Liqui-Gels?

No. Caplets use compressed-tablet excipients such as fillers, binders, disintegrants, lubricants, and film coatings. Liqui-Gels use a liquid fill and gelatin-based shell system. The excipient profiles differ materially.

Can a manufacturer replace ibuprofen with another NSAID in an Advil PM competitor?

A different NSAID would create a different product with separate regulatory, labeling, safety, and equivalence considerations. It would not be a direct equivalent to Advil PM.

Is diphenhydramine citrate interchangeable with diphenhydramine hydrochloride?

The salts are not interchangeable on a mass basis without accounting for molecular weight, formulation performance, labeling, and regulatory requirements. Advil PM uses diphenhydramine citrate at 38 mg, equivalent to 25 mg diphenhydramine.

Can an excipient supplier obtain patent protection for an improved Advil PM formulation?

Potentially, if the formulation has novel and non-obvious composition, performance, process, or stability characteristics. Patent value depends on claim scope, evidence, enforceability, and the ability to distinguish the invention from prior OTC combinations.

What is the most defensible commercial claim for a new Advil PM formulation?

A performance claim supported by validated dissolution, stability, human-use, or comparative data is more defensible than an unsupported claim of faster relief or superior sleep support. The claim must also comply with FDA OTC labeling requirements.

References

DailyMed. (n.d.-a). Advil PM Liqui-Gels: Ibuprofen and diphenhydramine citrate capsule, liquid filled. U.S. National Library of Medicine.

DailyMed. (n.d.-b). Advil PM: Ibuprofen and diphenhydramine citrate tablet, film coated. U.S. National Library of Medicine.

Haleon plc. (2024). Annual report and financial statements 2023. Haleon.

U.S. Food and Drug Administration. (n.d.-a). OTC monograph M013: Internal analgesic, antipyretic, and antirheumatic drug products. FDA.

U.S. Food and Drug Administration. (n.d.-b). OTC monograph M020: Nighttime sleep-aid drug products. FDA.

U.S. Food and Drug Administration. (n.d.-c). Inactive Ingredient Database. FDA.

United States Pharmacopeia. (n.d.). United States Pharmacopeia and National Formulary. USP.