ADVIL ALLERGY AND CONGESTION RELIEF Drug Patent Profile

When do Advil Allergy And Congestion Relief patents expire, and when can generic versions of Advil Allergy And Congestion Relief launch?

Advil Allergy And Congestion Relief is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in ADVIL ALLERGY AND CONGESTION RELIEF is chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride profile page.

Summary for ADVIL ALLERGY AND CONGESTION RELIEF

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	362
What excipients (inactive ingredients) are in ADVIL ALLERGY AND CONGESTION RELIEF?	ADVIL ALLERGY AND CONGESTION RELIEF excipients list
DailyMed Link:	ADVIL ALLERGY AND CONGESTION RELIEF at DailyMed

Recent Clinical Trials for ADVIL ALLERGY AND CONGESTION RELIEF

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Agenzia Italiana del Farmaco	PHASE4
IRCCS Policlinico S. Donato	PHASE4
Istanbul Medipol University Hospital	NA

See all ADVIL ALLERGY AND CONGESTION RELIEF clinical trials

Pharmacology for ADVIL ALLERGY AND CONGESTION RELIEF

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for ADVIL ALLERGY AND CONGESTION RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113-001	Dec 21, 2011		OTC	Yes	Yes

Advil Allergy and Congestion Relief Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 30, 2026

Advil Allergy and Congestion Relief is an over-the-counter combination product containing ibuprofen and pseudoephedrine hydrochloride. Its commercial position depends on brand strength, seasonal respiratory demand, retail distribution, and the continued legality and availability of oral pseudoephedrine. The product has limited proprietary protection because its active ingredients are established OTC drugs and its market is open to store-brand and generic competition.

Haleon owns the Advil brand portfolio. Haleon does not publicly report revenue or profit for the Advil Allergy and Congestion Relief SKU separately. Its financial trajectory therefore must be assessed through the Advil franchise, Haleon's consumer-health performance, category trends, and product-specific competitive factors rather than a disclosed SKU-level income statement.

What is Advil Allergy and Congestion Relief?

Advil Allergy and Congestion Relief is a U.S. OTC oral combination medicine marketed for temporary relief of allergy or cold-related nasal congestion, sinus pressure, headache, minor aches and pains, and fever.

Product characteristic	Details
Brand	Advil
Brand owner	Haleon plc
Product category	OTC respiratory and pain combination
Active ingredients	Ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg per dosage unit, based on U.S. product labeling
Dosage form	Oral caplets or tablets, depending on package configuration
Primary channels	Mass merchants, pharmacies, grocery, club stores, e-commerce
Prescription requirement	No prescription required, but pseudoephedrine sales are subject to federal and state controls
FDA pathway	OTC monograph-based marketing
Biosimilar exposure	None
Main competitors	Advil Cold and Sinus, Motrin IB and pseudoephedrine combinations, generic ibuprofen/pseudoephedrine products, store brands, and single-ingredient alternatives

Product labeling should be checked against the specific package because Advil sells several allergy, sinus, cold, and congestion products with different active-ingredient combinations. The FDA requires OTC combination products to comply with applicable monograph conditions, labeling requirements, and current good manufacturing practice standards.[1]

How does Advil Allergy and Congestion Relief make money?

The product generates revenue through branded OTC sales rather than prescription reimbursement. Its economics are driven by unit volume, retail price, promotional spending, retailer margins, and the mix between branded and private-label products.

The core commercial model has five components:

1. Premium pricing versus store brands.
2. High-volume placement in pharmacy and mass-retail cold-and-flu sections.
3. Seasonal demand during allergy, influenza, and common-cold periods.
4. Cross-selling from the broader Advil pain-relief franchise.
5. Convenience value from combining analgesic and decongestant ingredients in one product.

Combination products can command a higher shelf price than single-ingredient ibuprofen or pseudoephedrine products. That premium is vulnerable when consumers trade down to generic products or buy separate ingredients at lower total cost.

Because Haleon reports at brand and category levels rather than by individual Advil SKU, public filings do not provide a reliable standalone revenue figure for Advil Allergy and Congestion Relief. Haleon's reported results identify brand, category, geographic, and price-volume trends, but not detailed SKU profitability.[2]

What is the financial trajectory for Advil Allergy and Congestion Relief?

The product's likely financial trajectory is stable to modestly pressured in volume, with revenue supported by pricing and brand loyalty. The main commercial variables are:

Driver	Financial effect
Brand pricing	Supports revenue and gross profit but can accelerate private-label substitution
Respiratory season severity	Causes significant annual volume variation
Pseudoephedrine availability	Can constrain unit sales and increase substitution
Retailer promotion	Supports volume but reduces net realized price
Private-label penetration	Pressures market share and margins
E-commerce	Expands availability but increases price transparency
Product reformulation	Can protect distribution if consumer preferences change
Supply-chain costs	Affect gross margin, especially for low-priced OTC products

Haleon's broader consumer-health portfolio benefits from established brands, retail distribution, and repeat purchasing. Its reported financial performance is affected by price increases, currency movements, input costs, and consumer trade-down. Advil Allergy and Congestion Relief is exposed to each factor, but the SKU is too small within the consolidated company to drive Haleon's overall valuation independently.

The product's revenue profile is seasonal rather than recurring in the prescription sense. Demand tends to rise during periods of elevated respiratory illness, pollen exposure, and sinus symptoms. A weak season can reduce unit volume even when pricing remains favorable. A severe respiratory season can produce temporary retail inventory constraints and stronger sell-through.

How large is the competitive market?

The product competes in overlapping pain-relief, sinus, allergy, and oral decongestant markets. Its closest substitutes are not limited to products with identical ingredients.

Direct branded competitors

Direct branded competition includes products combining ibuprofen with pseudoephedrine, including Advil-branded sinus products and competing Motrin or retailer offerings. Brand architecture can create internal substitution when consumers select a different Advil SKU for the same symptoms.

Store brands and generic products

Private-label products are the principal structural threat. Retailers can sell ibuprofen and pseudoephedrine combinations at lower prices while using similar active ingredients and comparable OTC labeling. The product's clinical differentiation is limited because the active ingredients are long-established.

Generic manufacturers can compete through:

• Ibuprofen and pseudoephedrine combination tablets.
• Separate ibuprofen and pseudoephedrine products.
• Store-brand allergy and sinus lines.
• Multi-symptom cold products containing alternative analgesics.
• Single-ingredient antihistamines or nasal decongestants.

The branded product retains advantages in recognition, shelf placement, packaging, perceived quality, and consumer trust. Those advantages are strongest during urgent purchases, when consumers select a familiar product rather than compare active ingredients.

What FDA regulatory status applies to Advil Allergy and Congestion Relief?

Advil Allergy and Congestion Relief is an OTC product, not a conventional prescription New Drug Application product. Its regulatory position is based on compliance with FDA OTC monograph requirements and applicable labeling and manufacturing rules.

Ibuprofen is an established OTC analgesic and antipyretic ingredient. Oral pseudoephedrine is an established OTC nasal decongestant. The combination must meet requirements governing permitted ingredients, dosage, directions, warnings, labeling, and quality controls.[1]

The product is also affected by pseudoephedrine controls under the Combat Methamphetamine Epidemic Act. Retail sales generally require identification, sales logs, purchase limits, and restricted placement. State requirements can be stricter. These controls raise compliance costs and can reduce impulse purchases.[3]

The FDA's 2023 proposal regarding oral phenylephrine does not directly eliminate pseudoephedrine products. The regulatory issue for Advil Allergy and Congestion Relief is therefore operational control and availability of pseudoephedrine, not the phenylephrine efficacy proceeding.[4]

What patents protect Advil Allergy and Congestion Relief?

No meaningful product-specific patent barrier is apparent from the established active ingredients and OTC monograph pathway. Ibuprofen and pseudoephedrine are longstanding active ingredients with expired composition-of-matter protection.

Potential intellectual-property coverage could include:

• Tablet or caplet formulation technology.
• Coating or taste-masking systems.
• Packaging and child-resistant dispensing systems.
• Manufacturing processes.
• Brand trademarks and trade dress.
• Narrow formulation patents held by third parties.

These rights are unlikely to prevent competitors from marketing the same active ingredients in a conventional immediate-release dosage form. A competing manufacturer can generally avoid a narrow formulation claim by using a different excipient system, dosage form, coating, or manufacturing process.

Patent and exclusivity profile

IP category	Commercial significance
Active-ingredient patents	Expired or commercially unavailable as a barrier
FDA exclusivity	No new-drug exclusivity expected for the established OTC combination
Orange Book listing	No typical Orange Book protection expected for a monograph OTC SKU
Formulation patents	Possible but likely narrow and design-aroundable
Method-of-use patents	Limited value for general OTC symptom relief
Trademark rights	Important for brand positioning, but do not block generic active ingredients
Trade dress	Can deter copying of packaging appearance but does not prevent competitive products

When does Advil Allergy and Congestion Relief lose exclusivity?

The product does not have a conventional future patent-cliff date comparable to a prescription drug. Its principal exclusivity is commercial and brand-based rather than statutory.

There is no expected loss-of-exclusivity event tied to a single patent expiration date. Competition already exists through generic and private-label products. Market share can erode gradually through retailer expansion, price comparisons, product substitution, and lower-cost combination medicines.

This makes the commercial forecast different from a patented prescription medicine:

Prescription product	Advil Allergy and Congestion Relief
Often protected by patents and regulatory exclusivity	Primarily protected by trademark and consumer recognition
Generic entry can begin after a defined legal event	Competitive products are already available
Revenue cliff may follow patent expiry	Revenue erosion is gradual and seasonal
Prescription volume and reimbursement drive demand	Retail sell-through and consumer behavior drive demand

Are there Paragraph IV challenges or generic litigation?

A conventional Paragraph IV strategy is not the central competitive mechanism for this product. Paragraph IV litigation typically concerns an abbreviated new drug application that challenges listed patents for an FDA-approved prescription product or an eligible OTC product with Orange Book-listed patents.

For an OTC monograph combination such as Advil Allergy and Congestion Relief, competitors generally do not need to wait for a patent expiration date before marketing products that comply with the monograph and other FDA requirements. The practical risks are therefore:

• Labeling disputes.
• Formulation patent claims.
• Trade-dress disputes.
• Trademark opposition or infringement claims.
• Manufacturing and quality investigations.
• Retail distribution disputes.

No major public patent litigation materially blocking generic ibuprofen-pseudoephedrine competition is associated with the established combination in the ordinary OTC market.

What manufacturing and supply-chain barriers affect the product?

Manufacturing barriers are moderate rather than prohibitive. The active ingredients are widely known, and conventional tablets or caplets do not require complex biologic production, sterile filling, or specialized delivery technology.

The main barriers are commercial execution and compliance:

• Reliable sourcing of ibuprofen and pseudoephedrine.
• Federal and state pseudoephedrine recordkeeping.
• Quality control for combination-dose uniformity.
• Packaging that meets OTC and child-resistance requirements.
• Retailer scale and distribution agreements.
• Forecasting seasonal demand.
• Maintaining inventory during respiratory surges.

Pseudoephedrine regulation can favor large manufacturers because national retailers and established brands can absorb compliance and distribution costs more easily than smaller entrants. It does not, however, prevent generic production.

What licensing deals affect Advil Allergy and Congestion Relief?

The Advil brand is part of Haleon's consumer-health portfolio following the separation of the consumer-health business from GSK. Haleon also became a separately listed company after the demerger and business separation process involving GSK and Pfizer's former consumer-health assets.[5]

Public reporting does not identify a material product-specific licensing royalty stream for Advil Allergy and Congestion Relief. The economically important asset is the Advil trademark and associated consumer-health infrastructure. Any historical rights, transition arrangements, or portfolio-level agreements do not create a product-specific patent moat based on the public record.

How strong is the patent estate for Advil Allergy and Congestion Relief?

The patent estate is weak as a barrier to entry but the brand estate is stronger.

Protection type	Assessment
Composition-of-matter protection	None of practical relevance
Combination-product protection	Limited
Formulation protection	Potentially narrow
Manufacturing protection	Potentially process-specific
Regulatory exclusivity	Minimal
Trademark	Stronger than patent protection
Distribution scale	Material commercial advantage
Consumer recognition	Material commercial advantage

The product's defensibility depends on execution, not exclusion. Haleon's strongest advantages are brand awareness, retail access, packaging, advertising, and consumer familiarity with Advil ibuprofen products.

What generic entry risks exist for Advil Allergy and Congestion Relief?

Generic entry risk is high because competing products are already commercially feasible and generally available. The more relevant question is the rate of branded share loss.

Risk increases when:

• Retailers expand private-label shelf space.
• Inflation causes consumers to trade down.
• Pseudoephedrine products become less convenient to purchase.
• Consumers shift to single-ingredient products.
• Retailers reduce branded inventory.
• Competing products offer larger package sizes or lower unit costs.

Risk decreases when:

• Respiratory symptoms rise sharply.
• Consumers prioritize trusted brands.
• Haleon maintains strong promotional support.
• The product is available when alternatives are out of stock.
• Packaging clearly communicates combined pain and congestion relief.

How does Advil Allergy and Congestion Relief compare with single-ingredient alternatives?

Combination convenience is the product's main consumer proposition. A consumer who needs both analgesia and decongestion may prefer one caplet over separate products. That advantage disappears when the consumer needs only one symptom treatment or wants to control each ingredient independently.

Option	Advantage	Limitation
Advil Allergy and Congestion Relief	One product for pain and congestion	Higher ingredient exposure and less dosing flexibility
Ibuprofen alone	Lower cost and targeted pain relief	Does not treat nasal congestion
Pseudoephedrine alone	Targeted congestion relief	Does not treat pain or fever
Acetaminophen/decongestant product	Alternative analgesic combination	Different safety and consumer preference profile
Store-brand combination	Lower price	Less brand recognition
Intranasal decongestant	Localized nasal relief	Different use restrictions and delivery profile

What is the commercial outlook?

The base-case outlook is mature and cash-generative at the brand level, with limited unit-growth potential. Revenue can rise through pricing, distribution gains, or stronger respiratory seasons, but long-term market expansion is constrained by generic substitution and the maturity of the category.

The principal upside factors are brand pricing power, retail availability, seasonal demand, and continued consumer preference for combination products. The principal downside factors are private-label pricing, pseudoephedrine access restrictions, consumer trade-down, and loss of shelf space.

The product is unlikely to create a major patent-driven revenue event for Haleon. Its value lies in recurring OTC demand and brand economics rather than a time-limited exclusivity period.

Key Takeaways

• Advil Allergy and Congestion Relief is an OTC ibuprofen-pseudoephedrine combination marketed by Haleon.
• Haleon does not disclose revenue or profit for this SKU separately.
• The product has no meaningful patent cliff comparable to a patented prescription drug.
• Generic and private-label competition is already present.
• Pseudoephedrine regulation is a material operational and purchasing constraint.
• Brand recognition, retail distribution, and seasonal demand are the main commercial defenses.
• The financial trajectory is likely mature, seasonal, and pricing-supported rather than volume-led.
• No meaningful biosimilar, Paragraph IV, or Orange Book exclusivity risk is central to the product.
• Formulation and manufacturing patents may exist in the broader market, but they are unlikely to block conventional competing products.

FAQs

Is Advil Allergy and Congestion Relief covered by an Orange Book patent?

A conventional Orange Book patent barrier is not expected for this established OTC monograph product. Any relevant formulation or manufacturing rights would need to be evaluated separately from the active ingredients.

Can generic companies sell ibuprofen and pseudoephedrine combinations?

Yes. Manufacturers can market compliant products using established ibuprofen and pseudoephedrine ingredients, subject to FDA requirements and pseudoephedrine sales controls.

Does the FDA require a prescription for Advil Allergy and Congestion Relief?

No. The product is OTC, but pseudoephedrine purchases are subject to identification, quantity, recordkeeping, and placement requirements.

Is Advil Allergy and Congestion Relief exposed to the FDA phenylephrine decision?

The FDA's oral phenylephrine proceeding does not directly remove pseudoephedrine from the market. The product's relevant active decongestant is pseudoephedrine.

Does Haleon report Advil Allergy and Congestion Relief sales separately?

No separate SKU-level revenue or profit disclosure is generally provided in Haleon's public financial reporting. Advil results are reported within broader brand, regional, or consumer-health categories.

References

1. U.S. Food and Drug Administration. (2024). Over-the-counter monograph drugs and products. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs

2. Haleon plc. (2024). Annual report and financial statements 2023. https://www.haleon.com/investors

3. U.S. Drug Enforcement Administration. (2024). Combat methamphetamine epidemic act. https://www.deadiversion.usdoj.gov

4. U.S. Food and Drug Administration. (2023). FDA proposes order to remove oral phenylephrine as an OTC nasal decongestant active ingredient. https://www.fda.gov

5. Haleon plc. (2022). Haleon listing and separation materials. https://www.haleon.com/investors