Last Updated: May 11, 2026

Ibuprofen; phenylephrine hydrochloride - Generic Drug Details


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What are the generic sources for ibuprofen; phenylephrine hydrochloride and what is the scope of freedom to operate?

Ibuprofen; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and Perrigo R And D, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for ibuprofen; phenylephrine hydrochloride
Recent Clinical Trials for ibuprofen; phenylephrine hydrochloride

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

SponsorPhase
University of North Carolina, Chapel HillPHASE4
Ache Laboratorios Farmaceuticos S.A.Phase 3
PfizerPhase 3

See all ibuprofen; phenylephrine hydrochloride clinical trials

Pharmacology for ibuprofen; phenylephrine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for ibuprofen; phenylephrine hydrochloride
C01CA Adrenergic and dopaminergic agents
C01C CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01 CARDIAC THERAPY
C Cardiovascular system
C01EB Other cardiac preparations
C01E OTHER CARDIAC PREPARATIONS
C01 CARDIAC THERAPY
C Cardiovascular system
C05AX Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
G02CC Antiinflammatory products for vaginal administration
G02C OTHER GYNECOLOGICALS
G02 OTHER GYNECOLOGICALS
G Genito-urinary system and sex hormones
M01AE Propionic acid derivatives
M01A ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01 ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M Musculo-skeletal system
M02AA Antiinflammatory preparations, non-steroids for topical use
M02A TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02 TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M Musculo-skeletal system
R01AA Sympathomimetics, plain
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R01AB Sympathomimetics, combinations excl. corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R01BA Sympathomimetics
R01B NASAL DECONGESTANTS FOR SYSTEMIC USE
R01 NASAL PREPARATIONS
R Respiratory system
R02AX Other throat preparations
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
S01FB Sympathomimetics excl. antiglaucoma preparations
S01F MYDRIATICS AND CYCLOPLEGICS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01GA Sympathomimetics used as decongestants
S01G DECONGESTANTS AND ANTIALLERGICS
S01 OPHTHALMOLOGICALS
S Sensory organs

US Patents and Regulatory Information for ibuprofen; phenylephrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE ibuprofen; phenylephrine hydrochloride TABLET;ORAL 203200-001 Jul 3, 2014 OTC No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings ADVIL CONGESTION RELIEF ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022565-001 May 27, 2010 OTC Yes Yes ⤷  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

Ibuprofen; Phenylephrine Hydrochloride: Market dynamics and financial trajectory

Last updated: April 25, 2026

Ibuprofen plus phenylephrine hydrochloride is a fixed-dose, over-the-counter (OTC) combination commonly positioned for cold, flu, and “sinus” symptom relief. The commercial trajectory is driven by (1) OTC demand cycles tied to respiratory-seasonality, (2) shifting payer and regulatory scrutiny around phenylephrine’s clinical value in some geographies, and (3) price and channel mix across mass retail, club, and pharmacy chains. Financial outcomes typically follow the category’s volume elasticity under inflation and the brand-versus-private-label contest that intensifies in high-traffic seasons.

Where is the product positioned in demand and channel flow?

Demand drivers

  • Seasonality: Sales concentrate in colder months when upper-respiratory infections rise. This compresses demand into shorter quarters and lifts year-over-year growth at the seasonal peak, then normalizes in off-season.
  • Symptom bundling logic: The combination targets multiple complaint domains (pain/fever and nasal congestion) in a single OTC purchase, which supports repeat buying during peak respiratory waves.
  • Retail promo cadence: Mass-market OTC pricing is promotion-heavy, with private label gaining share when consumer trade-down accelerates.

Channel dynamics

Ibuprofen; phenylephrine hydrochloride products generally distribute through:

  • Mass retail (strong promotional pricing power and high-volume shelf placement)
  • Club stores (bulk purchase behavior in winter peaks)
  • Pharmacy chains (higher exposure to pharmacist-facing OTC guidance and planogram stability)

Channel mix matters financially because:

  • Private label share raises unit volume but usually caps gross margin.
  • Brand share supports margin but is pressured during high promo intensity and when consumer confidence weakens.

What market forces shape pricing, competition, and share?

Key competitive pressure points

  1. Phenylephrine efficacy scrutiny
    • Regulatory and clinical debates in multiple markets have affected demand confidence around oral phenylephrine’s effectiveness for nasal congestion, particularly where reformulations or alternative decongestant strategies are adopted.
  2. OTC switching behavior
    • Consumers switch quickly among congestion products when there is perceived efficacy variation, availability constraints, or price spikes. Switching reduces brand pricing power.
  3. Private label and store brand penetration
    • Store brands often match the active-ingredient label structure and undercut branded products during seasonal promotion windows.

Pricing and margin mechanics

  • Gross margin compression risk: OTC combinations face margin pressure from retailer negotiations, promotional discounting, and increased raw-material and logistics costs during inflationary periods.
  • Net revenue volatility: Short seasonal windows magnify the impact of promo intensity and in-stock rates. A strong winter can drive revenue spikes; a weak winter or supply disruption compresses profitability.

How does regulation and clinical evidence affect commercial trajectory?

The commercial path of ibuprofen; phenylephrine hydrochloride is sensitive to any policy action that changes:

  • Perceived clinical value of phenylephrine for nasal congestion,
  • Labeling, guidance, or monograph status for OTC decongestants,
  • Formulation or replacement product adoption (for example, shift to different decongestants, nasal sprays, or non-oral congestion relief approaches).

Where regulatory or evidence-based messaging challenges oral phenylephrine, the usual market response is:

  • accelerated switching to alternative congestion products,
  • increased private label and retailer-led assortment changes,
  • reduced ability for branded combos to hold price in winter peaks.

What do typical financial patterns look like for OTC cold-and-flu combinations?

Without instrument-level issuer filings for the specific combination by manufacturer, the financial trajectory should be modeled using OTC category norms and product-specific risk factors (phenylephrine efficacy scrutiny, seasonal demand, retailer promo intensity).

Revenue profile (pattern)

  • Quarterly revenue: Concentrated into winter quarters, with off-season decline.
  • YoY growth shape: Can show sharp peaks year over year during strong respiratory seasons, then revert.
  • Price vs volume contributions:
    • Inflation and list-price increases raise revenue per unit.
    • Promotions and store brands pull the mix toward lower net price, limiting margin.

Profit profile (pattern)

  • Gross margin: Pressured by retailer discounts and promotional intensity.
  • SG&A: Retail execution and seasonal marketing drive spend spikes ahead of peak demand.
  • Inventory management: Working capital tightness rises ahead of winter to secure supply, then unwinds after peak.

What does the product’s financial trajectory likely depend on in the next cycle?

The next twelve-to-eighteen-month outlook is typically determined by four levers:

  1. Regulatory and evidence environment for oral phenylephrine

    • Any tightening guidance or discouragement for oral phenylephrine reduces demand confidence and accelerates substitution.
  2. Retail assortment durability

    • Planogram strength in high-traffic stores (mass and pharmacy) supports volume.
    • If congestion assortment is reshuffled, the product can lose shelf presence quickly.
  3. Promotion strategy and price architecture

    • If the brand competes on price, share can grow while margins shrink.
    • If it holds price, it risks volume loss to lower-priced alternatives.
  4. Season severity

    • Respiratory season intensity is a direct driver of unit demand and supply utilization.

How should investors and R&D leaders read the trade-off between share and margin?

In OTC fixed-dose combinations, financial trajectory is rarely driven by long-cycle clinical adoption. It is driven by market mechanics:

  • Share gain usually comes with higher discounting.
  • Margin preservation usually requires either differentiation (brand equity or superior clinical perception) or retailer loyalty.
  • Phenylephrine-driven substitution risk increases the cost of holding price.
  • Private label competition tends to intensify when consumers seek value in peak season.

For a combination like ibuprofen; phenylephrine hydrochloride, the commercial center of gravity typically shifts during periods when oral decongestant value is questioned or alternative congestion products are stocked more heavily.

What is the key risk map for commercial outcomes?

Risk factor Mechanism Likely financial impact
Phenylephrine efficacy scrutiny Raises substitution to alternative congestion treatments Lower unit demand, weaker pricing power
Retail promotion intensity Increases channel discounting to protect shelf share Gross margin compression
Private label penetration Store brands gain shelf leverage during value-seeking periods Revenue mix shift to lower net price
Season severity variability Winter strength drives volume swings Revenue volatility by quarter
Supply and in-stock risk Lost sales during peak windows Downside to both revenue and working capital

What is the bottom-line market outlook?

The category outlook remains stable for OTC analgesic-antipyretic platforms (ibuprofen) but is more fragile for oral congestion components when clinical perception and regulatory messaging undermine efficacy. The financial trajectory for ibuprofen; phenylephrine hydrochloride therefore typically tracks:

  • stable base demand for pain/fever relief,
  • higher volatility from the congestion portion under evidence-driven substitution,
  • margin swings driven by retailer promo and private label competition during winter peaks.

From a business decision standpoint:

  • Near-term performance is most sensitive to winter seasonality, retail distribution, and promo execution.
  • Medium-term trajectory is most sensitive to regulatory and evidence dynamics around oral phenylephrine.

Key Takeaways

  • Ibuprofen; phenylephrine hydrochloride sells in a seasonal OTC cold-and-flu demand window, with revenue concentrated in winter quarters.
  • Commercial outcomes hinge on retailer assortment, promotion intensity, and private-label share, which directly affect net price and gross margin.
  • The product has structural substitution risk from oral phenylephrine efficacy scrutiny, which can weaken pricing power and accelerate switching to alternative congestion products.
  • Financial trajectories in this OTC segment tend to show revenue volatility by season severity and margin compression during heavy promotions.

FAQs

1) Is the product primarily a winter-season business?
Yes. OTC cold-and-flu demand concentrates into colder months, with quarterly revenue peaking in winter and normalizing in off-season.

2) What drives unit demand most: price or season intensity?
Season intensity usually drives unit demand more directly, while price and promotions govern how much of that demand stays with a branded combo versus store brands and alternative congestion products.

3) How does private label affect the financial profile?
Private label typically increases volume but compresses net price and gross margin, especially during peak promotional periods.

4) What is the biggest structural risk to the combination?
Efficacy perception and regulatory/evidence pressure around oral phenylephrine can reduce consumer confidence and accelerate substitution.

5) Does the analgesic component offset the congestion risk?
It can stabilize baseline demand because ibuprofen supports pain and fever relief, but it does not fully protect against substitution when congestion performance perceptions weaken the value of the combo.


References

[1] FDA. “Questionable Efficacy of Phenylephrine in Nasal Decongestant Products.” U.S. Food and Drug Administration. (Cited for regulatory/evidence framing around oral phenylephrine.)
[2] NHS. “Ibuprofen: Who can and cannot take it, and how to take it.” National Health Service. (General consumer reliance on ibuprofen-based OTC analgesia.)
[3] EMA. “Medicinal products containing phenylephrine.” European Medicines Agency materials on phenylephrine-containing medicinal products.

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