When will the patents on BENYLIN expire, and when will generic BENYLIN be available?

Sponsor	Phase
The Emmes Company, LLC	Phase 1/Phase 2
National Eye Institute (NEI)	Phase 1/Phase 2
The EMMES Corporation	Phase 1/Phase 2

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	BENYLIN	diphenhydramine hydrochloride; pseudoephedrine hydrochloride	SOLUTION;ORAL	019014-001	Jun 11, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Parke Davis	BENYLIN	diphenhydramine hydrochloride	SYRUP;ORAL	006514-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: September 27, 2026

Benylin is a mature over-the-counter cough, cold and allergy brand marketed primarily by Kenvue and its regional affiliates. The brand does not report standalone revenue, operating profit or volume. Its financial trajectory must therefore be assessed through Kenvue’s consumer-health results, category trends and regional product performance rather than a disclosed Benylin income statement.

Benylin’s core economics are driven by seasonal demand, pharmacy and grocery distribution, brand recognition, formulation changes, regulatory scrutiny and competition from private-label cough medicines. The brand has limited exposure to conventional prescription-drug patent risk because its products generally rely on long-established active ingredients and OTC regulatory pathways.

Who owns Benylin and where is the brand marketed?

Kenvue is the principal global consumer-health company associated with Benylin following the separation of Johnson & Johnson’s Consumer Health business. Regional ownership, licensing and distribution arrangements can differ by country.

Item	Position
Brand	Benylin
Main category	OTC cough, cold and allergy medicines
Principal corporate owner	Kenvue Inc. and regional affiliates
Former corporate parent	Johnson & Johnson
Main dosage forms	Syrups, oral liquids, capsules, tablets and other country-specific formats
Typical ingredients	Dextromethorphan, diphenhydramine, guaifenesin, ammonium chloride and related actives, depending on product
Primary channels	Pharmacies, supermarkets, grocery retailers, e-commerce and healthcare distributors
Revenue disclosure	No standalone Benylin revenue reported
Main geographic exposure	United Kingdom and selected international markets; product availability varies by country

The Benylin name does not represent one globally uniform product. Formulations, indications, age restrictions, packaging and legal status vary by jurisdiction. A Benylin cough syrup sold in the United Kingdom may have a different active ingredient combination from a product sold in Canada, South Africa or another market.

What is Benylin’s financial trajectory?

Benylin’s standalone financial trajectory is not publicly measurable from Kenvue’s filings. Kenvue reports company-wide and segment results, but does not separately disclose Benylin net sales, gross margin, market share or EBITDA.

Kenvue generated approximately $15.4 billion in 2023 sales across its consumer-health portfolio after becoming a public company. The portfolio included major brands such as Tylenol, Neutrogena, Listerine, Nicorette, Zyrtec, Aveeno and Motrin. Benylin is one of the smaller regional brands within that broader portfolio, and the filings do not identify its individual contribution. [1]

Financial indicators relevant to Benylin

Indicator	Implication for Benylin
No brand-level sales disclosure	Investors cannot calculate Benylin growth directly from public filings
Mature OTC category	Revenue is more dependent on volume, pricing and distribution than exclusivity
Seasonal demand	Sales are concentrated around winter respiratory illness periods
Retailer bargaining power	Large pharmacy and grocery chains can pressure pricing and promotional spending
Private-label competition	Store brands can substitute for established cough products
Portfolio allocation	Kenvue can prioritize higher-growth or higher-margin brands
Product recalls or reformulations	A single issue can affect retailer confidence and short-term sell-through
E-commerce growth	Improves availability but increases price transparency and comparison shopping

Kenvue’s overall results are a useful proxy for the parent company’s capacity to support Benylin, but they should not be treated as evidence of Benylin-specific growth. A stable or rising Kenvue revenue figure can coexist with flat or declining Benylin sales.

How does the cough and cold market affect Benylin?

The cough and cold market is seasonal, fragmented and highly promotion-sensitive. Demand increases during periods of influenza, respiratory syncytial virus, COVID-19 and other respiratory infections. The category also experienced abnormal demand patterns during and after the pandemic because of changes in social contact, school attendance and consumer stocking behavior.

Benylin competes across several subcategories:

Dry-cough suppressants
Chesty-cough and expectorant products
Combination cough and cold medicines
Night-time cough products
Pediatric cough medicines
Allergy and nasal-symptom products
Generic and private-label alternatives

The brand’s strongest commercial assets are consumer familiarity, shelf visibility and pharmacist recognition. Its main structural weaknesses are the low complexity of many formulations and the availability of cheaper alternatives containing the same active ingredients.

What drives Benylin sales?

Benylin revenue is likely influenced by five operating variables:

Respiratory disease incidence. Severe winter seasons can increase category demand, while mild seasons can reduce sell-through.
Retail distribution. Availability in major pharmacy and grocery chains directly affects unit volume.
Price and promotions. Consumers can switch readily among brands with similar ingredients.
Product format. Syrups, capsules and combination products address different consumer needs and price points.
Regulatory restrictions. Age limitations and labeling rules can reduce the addressable market for pediatric and combination products.

The most defensible commercial strategy is usually portfolio breadth rather than dependence on one formulation. A brand with dry-cough, chesty-cough, night-time and allergy products can shift demand across indications when one subcategory weakens.

What is Benylin’s competitive position versus generic cough medicines?

Benylin competes less on molecular differentiation than on branding, trust, availability and consumer convenience. The active ingredients in many products are mature and widely available from competing manufacturers.

Competitive factor	Benylin position	Commercial effect
Brand awareness	Strong in several markets	Supports premium pricing and repeat purchase
Ingredient exclusivity	Limited	Allows generic and private-label substitution
Product breadth	Broad but country-dependent	Supports shelf presence
Retail reach	Dependent on regional agreements	Creates uneven geographic performance
Pricing power	Moderate	Vulnerable during inflation and retailer promotions
Consumer switching cost	Low	Increases sensitivity to price and availability
Regulatory complexity	Moderate	Higher for pediatric and combination products
Patent protection	Generally limited	Does not provide a durable barrier to entry

Private-label products are a direct risk because retailers can offer equivalent active ingredients at lower prices. Branded products retain an advantage when consumers seek a familiar name, when a pharmacist recommends a specific product or when packaging communicates a clear symptom benefit.

What is the FDA regulatory status of Benylin?

Benylin’s regulatory status depends on the country and product. In the United States, OTC cough and cold products generally operate under FDA monograph rules or approved applications, depending on the formulation and regulatory history. FDA rules govern active ingredients, labeling, dosing, age restrictions and permissible claims. [2]

Benylin products sold outside the United States are not automatically covered by the FDA framework. United Kingdom products are governed by the Medicines and Healthcare products Regulatory Agency, including rules concerning authorization, labeling, pharmacovigilance and pediatric use. [3]

This distinction matters because a product’s commercial availability in one country does not establish approval, marketability or formulation legality in another.

Pediatric products and regulatory exposure

Pediatric cough and cold products face heightened scrutiny because of dosing errors, accidental ingestion and limited evidence of benefit in younger children. Regulators and manufacturers have restricted some products for young age groups and strengthened labeling requirements.

For Benylin, pediatric formulations can produce strong seasonal demand but also create higher compliance, safety-monitoring and reputation risks. A change in age labeling can reduce the addressable market without affecting the broader adult portfolio.

What patents and trademarks protect Benylin?

Benylin’s principal commercial protection is the trademark and associated brand equity, not a single active-ingredient patent estate.

The underlying ingredients are generally longstanding OTC compounds. Many formulations have been available for decades, making broad composition-of-matter patent protection unlikely to remain relevant. Potential intellectual-property rights may instead relate to:

Brand trademarks
Specific formulation combinations
Taste-masking systems
Packaging and delivery devices
Manufacturing processes
Product names and trade dress
Country-specific line extensions

The existence of a formulation patent would not necessarily prevent competitors from marketing the same active ingredient in a different formulation. Conversely, a trademark can prevent confusingly similar branding even where the medicine itself is not patent-protected.

Are Paragraph IV challenges relevant to Benylin?

Paragraph IV litigation is primarily associated with abbreviated new drug applications for patented prescription or approved drug products in the United States. It is not the central competitive mechanism for most mature Benylin products sold through OTC monograph pathways.

The more relevant entry mechanisms are:

Private-label launch under the same OTC conditions
Generic products using the same active ingredients
Retailer substitution
Reformulated competing brands
Regional product registrations
Contract-manufactured store brands

No publicly disclosed, brand-wide Paragraph IV dispute defines Benylin’s competitive position. Product-specific litigation could still arise if a particular formulation or approved application carried enforceable patent rights.

What litigation, recalls and regulatory events affect Benylin?

The brand’s key legal and regulatory risks are product-specific. They include labeling disputes, advertising claims, manufacturing deviations, adverse-event investigations, product recalls and trademark conflicts.

A 2024 recall involving certain Benylin pediatric syrup batches in Nigeria increased scrutiny of the brand’s quality-control and supply-chain processes. Public reporting linked the action to concerns about potentially elevated diethylene glycol levels in affected products. [4] The commercial effect of such an event depends on the affected lot, country, duration of the recall, retailer response and whether the issue extends to other products.

A localized recall does not establish a global product defect. It can, however, increase costs through testing, inventory destruction, replacement supply, regulatory engagement and consumer communications.

How strong is the Benylin patent estate?

Benylin has a weak-to-moderate exclusivity profile when assessed as an OTC brand.

Protection type	Relative strength	Assessment
Active-ingredient patents	Low	Core ingredients are mature
Broad formulation patents	Low to moderate	Depends on product and country
Trademark protection	High for the brand name	Supports brand control and anti-counterfeiting
Trade dress	Moderate	Can deter confusing presentation but is contestable
Manufacturing know-how	Moderate	May improve consistency, taste and cost
Distribution relationships	Moderate	Can restrict shelf access for smaller competitors
Consumer loyalty	Moderate	Provides some pricing support but does not prevent substitution

The brand’s defensibility is therefore commercial rather than pharmaceutical. Distribution, advertising, pharmacist recommendations and consumer recognition matter more than patent expiry dates.

What generic entry risks exist for Benylin?

Generic entry risk is persistent because the category has low switching costs and widely available ingredients. The most exposed products are simple single-ingredient or standard combination formulations with clear consumer substitutes.

Risk is lower where a Benylin product has:

A distinctive taste or delivery system
Strong pharmacist recommendation
A differentiated symptom claim
A convenient combination of active ingredients
High retail availability
Brand-specific consumer trust

Risk is higher where retailers can place an equivalent product directly beside Benylin at a substantially lower price. Inflation can accelerate this movement as consumers trade down.

What is the likely financial outlook for Benylin?

The base-case outlook is mature and defensive rather than high growth. Benylin can maintain revenue through price increases, distribution expansion, product renovation and seasonal demand, but sustained volume growth is difficult without new formats or geographic expansion.

Base-case outlook

Low-to-moderate revenue growth driven mainly by pricing and mix
Flat or declining unit volume in price-sensitive markets
Continued seasonal volatility
Ongoing private-label pressure
Stable contribution to Kenvue’s broader consumer-health portfolio
Limited benefit from pharmaceutical exclusivity

Upside factors

Strong respiratory seasons
Successful pediatric or adult product reformulation
Expansion in emerging markets
Improved e-commerce visibility
Premiumization through differentiated delivery formats
Higher consumer demand for recognizable brands during health scares

Downside factors

Weak respiratory seasons
Retailer delisting or reduced shelf space
Recall-related distrust
Pediatric restrictions
Ingredient shortages
Consumer trade-down to private label
Increased promotional spending
Manufacturing or quality-control failures

How does Benylin compare with other Kenvue brands?

Benylin has a less durable competitive position than brands supported by stronger recurring demand, higher product differentiation or broader global scale.

Kenvue brand type	Relative Benylin position
Daily-use oral care brands	Benylin has lower purchase frequency
Pain-relief brands	Benylin has more pronounced seasonality
Allergy brands	Benylin has greater formulation and symptom variability
Skin-care brands	Benylin generally has weaker premiumization potential
Nicotine-replacement products	Benylin has less regulatory exclusivity and lower treatment commitment

Benylin remains strategically useful as a recognized respiratory-health brand, but its value is likely measured through portfolio breadth, retailer access and cash contribution rather than high-growth potential.

Key Takeaways

Benylin is a mature Kenvue-associated OTC cough and cold brand with regional formulation differences.
Kenvue does not disclose Benylin’s standalone revenue, profit, volume or market share.
The brand’s financial performance is linked to respiratory seasonality, distribution, pricing and private-label competition.
Benylin has limited conventional patent protection because its core active ingredients are mature.
Trademark, consumer recognition, retail access and manufacturing know-how are more important than drug patents.
Paragraph IV litigation is not the primary competitive threat for most Benylin products.
Pediatric products carry higher regulatory, safety and recall exposure.
The likely outlook is stable to modest growth in revenue, with continued pressure on unit volume and margins.
A localized quality event or recall can create disproportionate short-term commercial damage.
Benylin’s principal long-term risks are substitution, retailer bargaining power and regulatory restrictions.

FAQs

Does Kenvue disclose Benylin sales separately?

No. Kenvue reports consolidated and segment-level results but does not provide standalone Benylin revenue or profitability.

Is Benylin a prescription medicine?

Benylin is primarily an over-the-counter brand, although regulatory classification and authorization vary by product and country.

Does Benylin have patent protection?

The brand name is protected primarily through trademarks. Some individual formulations may have formulation or manufacturing rights, but the mature active ingredients generally do not provide broad current exclusivity.

Can pharmacies substitute generic products for Benylin?

Substitution depends on local pharmacy rules and the product category. Consumers can generally choose competing OTC products with the same or similar active ingredients.

Is Benylin available in every country?

No. Availability, ownership, formulation, dosage form and regulatory status vary by jurisdiction.

References

Kenvue Inc. (2024). Annual report on Form 10-K for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission.
U.S. Food and Drug Administration. (n.d.). Over-the-counter drug review: Monograph system and OTC drug regulations. FDA.
Medicines and Healthcare products Regulatory Agency. (n.d.). Medicines legislation and guidance for non-prescription medicines. UK Government.
Kenvue Inc. (2024). Product recall and consumer safety communications relating to selected Benylin pediatric syrup products. Kenvue.

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	3,530
DailyMed Link:	BENYLIN at DailyMed

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