Last Updated: June 17, 2026

acetaminophen; ibuprofen sodium - Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Acetaminophen; ibuprofen sodium is the generic ingredient in one branded drug marketed by Hikma and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acetaminophen; ibuprofen sodium has seventy patent family members in thirty-one countries.

Summary for acetaminophen; ibuprofen sodium
International Patents:70
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for acetaminophen; ibuprofen sodium
Generic Entry Date for acetaminophen; ibuprofen sodium*:
Constraining patent/regulatory exclusivity:
Dosage:

SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for acetaminophen; ibuprofen sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX 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
Last updated: April 25, 2026

Investment scenario and fundamentals: acetaminophen and ibuprofen sodium

What is the market structure for acetaminophen and ibuprofen sodium?

Both acetaminophen (paracetamol) and ibuprofen sodium are classic, largely commoditized analgesic/antipyretic products with mature manufacturing, established payer coverage (where applicable), and pricing constrained by generic competition and OTC channel dynamics.

Key market reality

  • Acetaminophen: A high-volume, price-competitive analgesic with a long patent-free history in most jurisdictions.
  • Ibuprofen sodium: An ibuprofen salt form used for faster onset formulations in parts of the market; still largely generic and scale-driven.

Practical consequence for investors

  • Returns are driven more by channel execution, cost per unit, formulation scale, and regulatory/quality consistency than by patent-protected innovation.
  • Brand differentiation tends to concentrate in OTC “value” positioning, package/form factors, and patient-friendly dosing rather than durable exclusivity.

What are the core demand drivers and seasonality patterns?

Demand for both drugs tracks:

  • Seasonal infection and flu/cold cycles (winter peaks)
  • Injury and sports activity cycles (spring/summer upticks)
  • Household stocking behavior ahead of weather and travel periods
  • Chronic pain prevalence for arthritis and low back pain (ibuprofen slightly more tied to musculoskeletal pain narratives; acetaminophen has broad use in general pain)

Seasonality effect (investment implication)

  • Cash generation often follows a winter-heavy revenue curve for both molecules, with pricing more sensitive on OTC shelves in periods of promo intensity.

How do pricing and competitive dynamics typically behave?

Generic saturation

  • Both molecules have widespread generic availability. That compresses wholesale and retail margins and increases sensitivity to:
    • Raw material and packaging costs
    • Manufacturing yield and batch throughput
    • Channel mix (pharmacy chains vs mass retail vs e-commerce)
    • Competitive promotional cadence

Ibuprofen sodium specific angle

  • Salt form positioning can support slightly higher price points when it is tied to:
    • Label claims around onset (within permitted regulatory boundaries)
    • Pediatric formulations and dosing convenience
    • Combination products (depending on jurisdiction)

Even with salt-form advantages, overall pricing remains bounded by the broader ibuprofen market.


What are the fundamentals that matter for profitability?

For these products, the fundamental profit equation is not primarily innovation-driven. It is:

  • Manufacturing cost and scale
  • Regulatory compliance and batch reliability
  • Formulation stability and shelf life
  • Channel contracts and inventory turns
  • Liability and safety risk management (standardized quality systems reduce disruption cost)

What investors should look for

  1. COGS discipline
    • API procurement terms (direct vs broker)
    • Conversion cost per batch and yield
  2. Quality system maturity
    • Batch rejection rates
    • CAPA cycle times
  3. Inventory and working capital
    • Trade inventory policies
    • Ageing and markdown behavior in OTC downcycles
  4. Portfolio resilience
    • Mix between single-entity and combination products
    • Exposure to store brands versus branded SKUs

What is the regulatory landscape risk for these molecules?

No patent moat exists as a primary barrier for new entrants. Regulatory risk is about enforcement and product quality rather than exclusivity.

Risk categories

  • GMP and supply chain quality (DMF/CEP compliance where applicable)
  • Labeling and claim scrutiny for onset and intended use
  • Safety signal management and pharmacovigilance requirements (standard across manufacturers)

Investment implication

  • Quality lapses and enforcement can create immediate financial drag via recalls, margin compression, and loss of supply approvals.

How do safety and utilization constraints affect revenue?

These drugs face long-running safety considerations, which influence:

  • Prescriber behavior for some indications
  • OTC packaging and risk wording
  • Pharmacy counseling patterns
  • Patient selection (dose limits, contraindication screening)

Acetaminophen

  • Dose and liver injury risk drives strict labeling and patient education in many markets.

Ibuprofen (and ibuprofen sodium)

  • Gastrointestinal and renal risk profile drives contraindication and caution language, influencing patient selection.

Investment implication

  • Revenue growth is capped more by utilization boundaries and risk messaging than by patient demand.

What does an investment scenario look like for a new entrant versus an established manufacturer?

Because the molecules are mature, the investment scenario separates into two lanes.

Lane 1: Cost-and-supply scale play (established manufacturer)

  • Strengths: existing manufacturing, regulatory footprint, distribution relationships
  • Likely edge: ability to produce at lower COGS, keep fill rates high, and sustain contracts

Value creation levers

  • Lower COGS per unit
  • Higher yield and fewer batch deviations
  • Better working capital turns
  • Channel mix that reduces promotional drag

Lane 2: Formulation and channel differentiation (new or mid-size entrant)

  • Strengths: faster time-to-market with compliant formulations, differentiated delivery (especially for ibuprofen sodium)
  • Limits: inability to defend price with exclusivity; dependence on promo and contracts

Value creation levers

  • Specialty formats (effervescent, liquid, fast-release) where permitted and commercially justified
  • Tight inventory planning for seasonal windows
  • Strong retail partnerships for shelf placement

What are the patent and exclusivity realities (core to investment thesis)?

For acetaminophen and ibuprofen sodium, durability comes from exclusivity types other than classic composition-of-matter patents, such as:

  • Orphan or special use cases (rare for these staples)
  • Specific formulation approvals (where they exist and remain in force)
  • Data exclusivity tied to specific jurisdictions and regulatory submissions
  • Market protection via complex manufacturing/combination products where permitted

In general, the molecules themselves are not the source of a scalable patent moat for investors; supply chain execution becomes the determinant.


What should diligence focus on for acetaminophen?

Investment diligence should prioritize:

  • API supplier reliability and pricing volatility exposure
  • Bulk-to-finish conversion capacity
  • Stability performance (degradation rates affect shelf life and returns)
  • OTC regulatory compliance and label version control
  • Product mix (single-entity vs combination) and margin sustainability by channel

Commercial implication

  • Acetaminophen economics often depend on promotional intensity and inventory turnover, not on differentiation.

What should diligence focus on for ibuprofen sodium?

For ibuprofen sodium:

  • Salt form consistency and particle characteristics that affect dissolution and performance
  • Formulation stability tied to sodium salt behavior under humidity/temperature
  • Claim substantiation and label control (onset and indication language)
  • Scale-up learnings for fast-release or liquid formats
  • Pediatric and dosing convenience SKUs where buyer preference drives repeat purchase

Commercial implication

  • Ibuprofen sodium can offer a limited differentiation path via delivery and onset positioning, but it still competes against the entire ibuprofen ecosystem.

What profitability benchmarks are rational for investors (how to think about margins)?

For mature, generic-dominated OTC analgesics, margins typically track:

  • Bulk commodity pricing for API
  • Packaging and freight
  • Retail and pharmacy distribution terms
  • Promotional spend requirements
  • Returns and damages

Model margin sensitivity

  • Revenue is least sensitive to units in the short term (volume remains high), but:
    • Gross margin is sensitive to COGS swings
    • Operating margin is sensitive to promo intensity and supply disruptions

What is the investment thesis under different macro cases?

Case A: Stable inflation / stable demand

  • Scale producers hold share by maintaining shelf fill and cost control.
  • Ibuprofen sodium differentiation can support modest share gains in fast-onset formats.

Case B: Commodity input pressure

  • API price spikes can compress margin unless contracts are pass-through or inventory timing offsets.
  • The strongest operators negotiate supply terms and manage buffer stock.

Case C: Retail promo escalation

  • Brands and best-in-class suppliers defend mix; others lose margin and shelf velocity.
  • Expect accelerated pressure toward store brands.

How should investors structure exposure (equity, bonds, or procurement-backed deals)?

Because the products are mature and commoditized, structures that align incentives matter.

Preferred structures

  • Contracted manufacturing and supply agreements tied to volume and quality
  • Channel-secured revenue (OTC retailer agreements) with minimum purchase commitments
  • Balance sheet discipline focused on liquidity for working capital and inventory seasonal swings

Less attractive structures

  • Uncontracted spot procurement exposure without margin protection
  • Highly leveraged profiles that cannot absorb seasonal inventory and promo drawdowns

Key Takeaways

  • Acetaminophen and ibuprofen sodium are mature analgesics where pricing power is structurally constrained by generic competition.
  • Investment returns depend primarily on manufacturing cost, regulatory quality stability, supply reliability, and channel execution, not on patent exclusivity.
  • Ibuprofen sodium can support limited differentiation through formulation and dosing convenience, but it still competes broadly within ibuprofen.
  • Diligence should stress COGS yield, shelf-life/stability performance, working capital controls, and promo sensitivity.

FAQs

  1. Is acetaminophen a patent-driven investment opportunity?
    No. The core molecule is broadly generic; durable advantage typically comes from supply chain execution, formulation-specific protections (if any), and channel contracts.

  2. What is the main driver of returns for these drugs?
    Cost per unit, manufacturing reliability, and inventory turnover under OTC seasonality and promo cycles.

  3. Does ibuprofen sodium offer a meaningful moat vs generic ibuprofen?
    It can support differentiation through fast-release or formulation performance, but it does not usually create a patent-grade moat across markets.

  4. How should investors model downside risk?
    Use margin compression scenarios from API input shocks, increased promotional spend, and any disruption from quality enforcement.

  5. What diligence item most directly impacts earnings volatility?
    Batch yield and the cost of deviations, combined with working capital intensity during seasonal peaks.


References

[1] U.S. Food and Drug Administration. “Drug Safety Communications and Regulatory Information on Acetaminophen and NSAIDs.” (FDA website).
[2] European Medicines Agency. “Paracetamol (acetaminophen) and ibuprofen product information and safety communications.” (EMA website).
[3] World Health Organization. “Guidance on quality assurance of pharmaceuticals and GMP principles.” (WHO publications).

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.