List of Excipients in Branded Drug IBUPROFEN AND PSEUDOEPHEDRINE HCL

Generic Drugs Containing IBUPROFEN AND PSEUDOEPHEDRINE HCL

Company	Ingredient	NDC	Excipient
WALGREEN CO	ibuprofen and pseudoephedrine hcl	0363-1106	D&C YELLOW NO. 10
WALGREEN CO	ibuprofen and pseudoephedrine hcl	0363-1106	FD&C RED NO. 40
WALGREEN CO	ibuprofen and pseudoephedrine hcl	0363-1106	FERROSOFERRIC OXIDE
WALGREEN CO	ibuprofen and pseudoephedrine hcl	0363-1106	GELATIN

What are the Most Frequently-Used Excipients in IBUPROFEN AND PSEUDOEPHEDRINE HCL?

# Of NDCs	Excipient
5	D&C YELLOW NO. 10
5	FD&C RED NO. 40
5	FERROSOFERRIC OXIDE
5	GELATIN

Ibuprofen and Pseudoephedrine HCl Excipient Strategy and Commercial Opportunities

Last updated: August 24, 2026

Ibuprofen and pseudoephedrine HCl is a mature over-the-counter combination with low active-ingredient patent risk and meaningful formulation, supply-chain, regulatory, and channel opportunities. The standard U.S. product combines ibuprofen 200 mg with pseudoephedrine HCl 30 mg for immediate-release pain relief and nasal congestion. Extended-duration products may pair ibuprofen 200 mg with pseudoephedrine HCl 120 mg.

The strongest commercial positions are private-label supply, differentiated dosage forms, cleaner excipient systems, moisture-controlled packaging, and products designed for behind-the-counter pharmacy distribution. New-molecule exclusivity is unavailable, while formulation patents are possible but difficult to sustain against a simple immediate-release tablet.

What products contain ibuprofen and pseudoephedrine HCl?

The principal commercial presentations are immediate-release tablets, caplets, liquid-filled capsules, and extended-release tablets.

Product type	Typical ibuprofen dose	Typical pseudoephedrine HCl dose	Primary use
Immediate-release tablet or caplet	200 mg	30 mg	Pain, fever, sinus pressure, nasal congestion
Liquid-filled capsule	200 mg	30 mg	Faster consumer-perceived onset and swallowability
Extended-release tablet	200 mg	120 mg	Longer-duration congestion relief
Multi-symptom product	200 mg	30 mg	Sinus symptoms with added cough, antihistamine, or expectorant

U.S. branded products include Advil Cold & Sinus and related ibuprofen-pseudoephedrine presentations. Generic and store-brand products are sold by retailers and manufacturers including Perrigo, private-label suppliers, and regional pharmaceutical companies. Brand ownership and product authorization can differ by market and presentation.

The combination is pharmacologically rational because ibuprofen addresses pain, fever, and inflammation, while pseudoephedrine produces systemic nasal decongestion through sympathomimetic vasoconstriction. The combination does not require a new active pharmaceutical ingredient or a biologic manufacturing platform.

What excipient strategy is appropriate for an ibuprofen-pseudoephedrine tablet?

A conventional immediate-release tablet should prioritize dose uniformity, rapid disintegration, low moisture exposure, and reliable coating performance.

Recommended immediate-release excipient architecture

Formulation function	Candidate excipients	Development rationale
Diluent and compressibility	Microcrystalline cellulose, lactose monohydrate, dibasic calcium phosphate	Supports tablet weight, hardness, and manufacturability
Binder	Povidone, copovidone, pregelatinized starch	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone, sodium starch glycolate	Promotes rapid breakup after administration
Glidant	Colloidal silicon dioxide	Improves powder flow and die filling
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces ejection force and tooling adhesion
Film coating	Hypromellose, polyethylene glycol, mineral pigments, titanium dioxide where permitted	Controls appearance, swallowability, and moisture protection
Taste and odor control	Film coating, low-odor excipient system	Limits the sensory impact of pseudoephedrine and ibuprofen

Direct compression is commercially attractive because it reduces processing steps and avoids water or solvent exposure. Wet granulation may improve content uniformity and tablet robustness, but it increases process complexity and can create moisture-related stability risks.

Ibuprofen has poor aqueous solubility. Pseudoephedrine HCl is water soluble and can be hygroscopic. The formulation therefore has an asymmetric physical profile: one active is dissolution-limited, while the other is more sensitive to moisture and migration during processing. Particle-size control, blending order, lubrication time, and humidity control are critical.

How should excipients address ibuprofen dissolution?

Ibuprofen dissolution can be improved through:

• Smaller active-particle size.
• Wetting agents such as sodium lauryl sulfate, subject to sensory and regulatory review.
• Hydrophilic disintegrants.
• Amorphous or solid-dispersion approaches, where justified by stability data.
• Granulation strategies that prevent hydrophobic ibuprofen from coating other particles.
• Optimized film-coating weight that does not delay tablet disintegration.

The lowest-cost strategy is usually particle engineering combined with a strong disintegrant system. A complex solubility-enhancement platform may increase manufacturing cost without producing a commercially meaningful advantage in a mature OTC category.

How should excipients manage pseudoephedrine HCl?

Pseudoephedrine HCl requires control of moisture, segregation, and electrostatic behavior. The active is typically used as a crystalline powder and should be evaluated for:

• Hygroscopicity under accelerated conditions.
• Particle-size distribution and density mismatch with ibuprofen.
• Blend uniformity at low dosage relative to total tablet mass.
• Interaction with alkaline excipients.
• Stability under high humidity.
• Potential migration in liquid-filled or multilayer systems.

Low-moisture excipients, controlled-humidity manufacturing, and high-barrier packaging can be more valuable than adding a large number of formulation excipients.

What formulation patents could protect this combination?

The active ingredients are old, widely available, and generally exposed to generic competition. Patentable subject matter is more likely to involve the dosage form or manufacturing process.

Potential claim areas include:

1. Immediate-release tablets with defined dissolution windows.
2. Bilayer tablets combining immediate-release ibuprofen with extended-release pseudoephedrine.
3. Liquid-filled capsules with a defined nonaqueous fill composition.
4. Abuse-deterrent or extraction-resistant pseudoephedrine systems.
5. Moisture-stable formulations with specified impurity limits.
6. Particle-size distributions that improve ibuprofen dissolution.
7. Taste-masked or low-odor dosage forms.
8. Fixed-dose combinations with a defined ratio and pharmacokinetic profile.
9. Manufacturing processes that improve blend uniformity or reduce degradation.
10. Child-resistant or unit-dose packaging integrated with the product presentation.

A patent based only on combining ibuprofen and pseudoephedrine is unlikely to provide durable protection because the combination is established in commerce. A defensible patent would need a specific formulation limitation, measurable performance benefit, or manufacturing advantage that is not obvious from existing OTC products.

When does ibuprofen and pseudoephedrine lose exclusivity?

The active ingredients have no meaningful remaining composition-of-matter exclusivity in the United States. Standard immediate-release combinations are generally subject to generic substitution and private-label competition.

Exclusivity layer	Current commercial position
Ibuprofen active-ingredient patent	Expired
Pseudoephedrine HCl active-ingredient patent	Expired
Basic fixed-dose combination	Mature and exposed to competition
Brand trademark	May remain enforceable
Product-specific formulation patent	Possible, but must be checked by product and jurisdiction
FDA OTC monograph pathway	Available for conforming products
New drug exclusivity	Not expected for a standard monograph-compliant product

The commercial moat is therefore created by brand recognition, retail placement, packaging, supply reliability, consumer trust, and product differentiation. A new entrant does not need to overcome a strong active-ingredient patent estate, but it must meet FDA requirements and secure compliant pseudoephedrine distribution.

What is the FDA regulatory status of ibuprofen and pseudoephedrine HCl?

Ibuprofen is an established OTC analgesic and antipyretic active. Pseudoephedrine is an established oral nasal decongestant. U.S. products must comply with applicable OTC monograph conditions, labeling requirements, dosage restrictions, and manufacturing standards under FDA regulations, including 21 C.F.R. parts 210, 211, and 341.

The FDA’s action concerning oral phenylephrine does not eliminate pseudoephedrine as an oral decongestant. The regulatory issues are different: pseudoephedrine remains subject to controlled-sale requirements because it can be diverted for illicit methamphetamine production, while phenylephrine has faced questions about oral effectiveness.

What pseudoephedrine restrictions affect commercialization?

The Combat Methamphetamine Epidemic Act establishes federal sales limits for pseudoephedrine products. Retailers generally must:

• Keep products behind the counter or in a controlled-access area.
• Verify purchaser identification.
• Maintain required sales records.
• Observe daily and monthly purchase limits.
• Comply with state-specific electronic tracking requirements.

The federal limits generally include 3.6 grams per purchaser per day and 9 grams over a 30-day period, subject to statutory and regulatory exceptions. State laws can impose stricter controls. These restrictions make pseudoephedrine products less convenient than phenylephrine or topical decongestants and can reduce retail shelf visibility.

What is the Orange Book status of this combination?

A standard OTC monograph product is not ordinarily protected through an Orange Book-listed patent in the same way as an approved prescription NDA product. Orange Book status depends on the specific marketed product, its regulatory pathway, and whether an NDA or other qualifying application supports the listing.

For a commercial diligence review, the relevant analysis is product-specific:

Question	Commercial implication
Is the product marketed under an OTC monograph?	Usually limited patent-listing exposure
Is the product supported by an NDA?	Potential Orange Book and Paragraph IV relevance
Are formulation patents listed?	Could delay or complicate generic entry
Is the patent directed to a method of use?	May be difficult to enforce against OTC labeling
Is the patent expired or disclaimed?	Little practical entry protection
Is the claim limited to packaging or process?	Narrower enforcement scope

Paragraph IV challenges are most relevant if a branded product has an approved NDA with unexpired listed patents. For ordinary OTC monograph products, a competitor usually does not need to file an ANDA challenging an Orange Book patent. It can market a conforming product, subject to FDA compliance, trademark clearance, labeling requirements, and pseudoephedrine controls.

Which companies are challenging or competing with the branded products?

Competition is fragmented. It includes branded consumer-health companies, generic manufacturers, pharmacy chains, mass retailers, and contract manufacturers.

The relevant competitive groups are:

• Haleon and other branded OTC companies using established ibuprofen brands.
• Perrigo and other private-label suppliers.
• Retailer-owned brands sold through pharmacy, grocery, club, and mass channels.
• Online pharmacy and marketplace sellers, subject to pseudoephedrine restrictions.
• Manufacturers offering liquid-filled capsules, extended-release tablets, or sinus multi-symptom products.

The most significant competitive advantage is often retailer access rather than patent ownership. Retailers can switch suppliers when a manufacturer offers lower cost, reliable supply, compliant packaging, and acceptable consumer ratings.

What commercial opportunities exist in excipient and dosage-form development?

Can a low-cost generic tablet compete?

Yes. A simple immediate-release tablet has the clearest path to market and the lowest technical risk. The commercial challenge is price competition and retailer qualification. A successful supplier should optimize:

• Tablet weight and compression efficiency.
• High-speed manufacturing yield.
• Low coating-material consumption.
• Stable supply of ibuprofen and pseudoephedrine HCl.
• Packaging cost per treatment course.
• Batch release testing for dissolution and content uniformity.

Is there an opportunity for a liquid-filled capsule?

Liquid-filled capsules can support premium positioning through swallowability and consumer-perceived speed. The formulation must manage ibuprofen solubility, capsule-shell compatibility, fill viscosity, leakage, and pseudoephedrine stability.

A nonaqueous fill may use polyethylene glycol or another compatible vehicle, but the selected system must avoid active precipitation, shell brittleness, migration, and accelerated degradation. This format can support a differentiated brand, though manufacturing capital and quality-control requirements are higher than for tablets.

Is an extended-release combination commercially attractive?

An extended-release ibuprofen-pseudoephedrine product can command a premium because it reduces dosing frequency. The main technical challenge is delivering different release profiles from two actives:

• Ibuprofen may require immediate or controlled release for pain relief.
• Pseudoephedrine may require a prolonged release over approximately 12 hours.
• A bilayer or multiparticulate system can separate the release mechanisms.
• Matrix polymers such as hypromellose may control pseudoephedrine release.
• Coated pellets or granules can provide more precise release control but raise cost.

This type of product has stronger potential for formulation IP than a conventional tablet. It also faces greater bioequivalence, dissolution, stability, and manufacturing risk.

Which “clean label” products have potential?

Consumer-facing differentiation can include:

• Dye-free tablets.
• Sugar-free liquid formulations.
• Gluten-free claims where substantiated.
• Vegan or gelatin-free capsules.
• Reduced-excipient products for sensitive consumers.
• Unit-dose blister packaging.
• Moisture-resistant travel packs.
• Smaller tablets with equivalent active content.

These features are primarily marketing and formulation opportunities, not strong barriers to entry. Claims must be supported and must comply with FDA labeling requirements.

What manufacturing and supply-chain barriers affect market entry?

Pseudoephedrine creates a more restrictive supply chain than ordinary OTC analgesics. Manufacturers must manage precursor controls, inventory records, customer qualification, and distribution monitoring. Retail customers may also require serialized or electronically tracked fulfillment.

Key operational risks include:

• Pseudoephedrine quota and procurement constraints.
• Supplier concentration for pharmaceutical-grade active material.
• Moisture-related degradation.
• Blend segregation caused by density differences.
• Dissolution failures from ibuprofen’s poor solubility.
• Packaging failures under high humidity.
• Retailer requirements for lot traceability.
• State-specific restrictions on sales and fulfillment.

High-barrier blister packs can reduce stability risk but may increase packaging cost. Bottles are less expensive but require desiccant selection, induction sealing, child-resistant closures where applicable, and careful control of headspace humidity.

What generic launch scenarios exist?

Immediate-release tablet launch

This is the most likely entry scenario. The entrant competes on cost, retailer access, packaging, and supply reliability. Patent risk is low unless the target product has an unusual NDA-supported formulation.

Liquid-filled capsule launch

This supports a differentiated consumer presentation and potentially higher gross margins. The main risks are formulation stability, shell compatibility, and capital requirements.

Extended-release launch

This creates more technical differentiation and potential formulation patents. It requires stronger development capabilities and may encounter product-specific regulatory hurdles.

Private-label retailer launch

This is commercially attractive because retailers can replace an incumbent supplier without building a national brand. The supplier must meet aggressive cost targets and maintain uninterrupted supply during seasonal demand spikes.

How strong is the patent estate for ibuprofen and pseudoephedrine HCl?

The patent estate is weak at the active-ingredient level and potentially moderate at the product-specific formulation level.

IP category	Relative strength
Ibuprofen composition of matter	Very weak; expired
Pseudoephedrine HCl composition of matter	Very weak; expired
Basic fixed-dose combination	Weak
Immediate-release excipient blend	Usually weak unless narrowly claimed
Extended-release architecture	Moderate if clinically and technically differentiated
Liquid-filled capsule system	Moderate if stability and release claims are specific
Packaging and child-resistance	Narrow, commercially useful but easy to design around
Brand trademark and trade dress	Potentially significant
Manufacturing know-how	Commercially important but not always patent-protected

Trade secrets involving particle sizing, coating parameters, blend order, and packaging moisture control may provide more practical value than a narrow formulation patent.

Key Takeaways

• Ibuprofen and pseudoephedrine HCl is a mature OTC combination with no meaningful active-ingredient exclusivity.
• The standard 200 mg/30 mg immediate-release tablet has low patent risk and high price competition.
• Excipient development should focus on ibuprofen dissolution, pseudoephedrine moisture control, blend uniformity, rapid disintegration, and packaging stability.
• Liquid-filled capsules and extended-release systems offer greater differentiation but carry higher technical and regulatory cost.
• Commercial opportunity is strongest in private label, retailer supply, clean-label products, unit-dose packaging, and differentiated release profiles.
• Pseudoephedrine controls under federal and state law are a more material market-entry issue than active-ingredient patents.
• Orange Book and Paragraph IV risk depend on the specific product’s NDA and patent listings rather than the ingredient combination alone.
• Formulation patents may be useful, but brand, channel access, manufacturing know-how, and supply reliability are likely to determine commercial performance.

FAQs

Can ibuprofen and pseudoephedrine HCl be formulated in one immediate-release tablet?

Yes. The combination is technically feasible, but development must address ibuprofen’s poor water solubility, pseudoephedrine’s moisture sensitivity, blend uniformity, and rapid disintegration.

Which excipient is most important for ibuprofen dissolution?

No single excipient determines performance. A hydrophilic disintegrant, controlled particle size, suitable wetting strategy, and optimized granulation or direct-compression process usually have the greatest combined effect.

Does pseudoephedrine require a prescription in the United States?

Generally no, but federal and state law restrict retail access, purchase quantities, identification, recordkeeping, and distribution. Products are commonly sold behind the pharmacy counter.

Can an OTC company patent a new ibuprofen-pseudoephedrine product?

It can seek patents for a specific formulation, release profile, manufacturing method, or packaging system. A patent covering only the known combination is unlikely to provide meaningful protection.

Are biosimilar risks relevant to ibuprofen and pseudoephedrine HCl?

No. Both are small-molecule active ingredients. The relevant competitive threats are generic, private-label, branded OTC, and authorized-generic products rather than biosimilars.

References

1. U.S. Food and Drug Administration. (n.d.). 21 C.F.R. Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Electronic Code of Federal Regulations.

2. U.S. Food and Drug Administration. (n.d.). Current good manufacturing practice for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. Electronic Code of Federal Regulations.

3. U.S. Congress. (2005). Combat Methamphetamine Epidemic Act of 2005, Title VII of the USA PATRIOT Improvement and Reauthorization Act.

4. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

5. U.S. Food and Drug Administration. (2023). FDA proposes reclassification of oral phenylephrine as not generally recognized as effective. FDA.