Last Updated: August 8, 2026

MUCINEX Drug Patent Profile


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When do Mucinex patents expire, and when can generic versions of Mucinex launch?

Mucinex is a drug marketed by Reckitt Benckiser and is included in four NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in MUCINEX is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

DrugPatentWatch® Generic Entry Outlook for Mucinex

Annual sales in 2022 were $1mm indicating the motivation for generic entry (peak sales were $27mm in 2007).

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Recent Clinical Trials for MUCINEX

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

SponsorPhase
Vitaccess LtdPhase 4
American Health ResearchPhase 4
Massachusetts Eye and Ear InfirmaryN/A

See all MUCINEX clinical trials

Pharmacology for MUCINEX
Paragraph IV (Patent) Challenges for MUCINEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MUCINEX Extended-release Tablets guaifenesin 600 mg and 1.2 gm 021282 1 2006-06-09

US Patents and Regulatory Information for MUCINEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Reckitt Benckiser MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Reckitt Benckiser MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM dextromethorphan hydrobromide; guaifenesin; naproxen sodium TABLET, EXTENDED RELEASE;ORAL 217338-001 Dec 22, 2025 OTC Yes Yes 12,370,189 ⤷  Start Trial Y ⤷  Start Trial
Reckitt Benckiser MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620-002 Apr 29, 2004 OTC Yes 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

Expired US Patents for MUCINEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 7,838,032 ⤷  Start Trial
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 6,372,252 ⤷  Start Trial
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-002 Dec 18, 2002 7,838,032 ⤷  Start Trial
Reckitt Benckiser MUCINEX guaifenesin TABLET, EXTENDED RELEASE;ORAL 021282-001 Jul 12, 2002 6,955,821 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Last updated: July 21, 2026

MUCINEX (Guaifenesin) Market Dynamics and Financial Trajectory (US and Key International Exposure)

MUCINEX is a household OTC brand built on guaifenesin, with revenue driven by cold and cough seasonality, product-line expansion (extended-release tablets, fast-acting formats, combo products), and channel execution in US mass retail, drugstore chains, and e-commerce. Financial trajectory is shaped by (1) category cyclicality, (2) generic competition at the API level with brand differentiation at the formulation and labeling level, (3) promotional intensity, and (4) regulatory and ingredient scrutiny common to OTC cough-cold products.

This profile focuses on market structure and the business forces that determine MUCINEX cash flows, margin pressure, and growth rates.


How does MUCINEX guaifenesin sell in the OTC cough and cold market?

Where MUCINEX sits in the cough-cold OTC value chain

MUCINEX is not a prescription product and does not operate on the “patent expiry to generic launch” lifecycle in the same way as Rx. Instead, MUCINEX competes in an OTC category where:

  • The active ingredient guaifenesin is long off-patent as an API in most jurisdictions.
  • Brand value is concentrated in dosing convenience (extended release), product format, and consumer trust.
  • Pricing is mostly market-share and promo driven rather than driven by exclusivity.

Core product system that governs repeat purchasing

MUCINEX’s US lineup typically includes:

  • Extended-release guaifenesin tablets (seasonal hero SKU in many markets)
  • Fast-acting or “maximum strength” guaifenesin formats
  • Combo products that pair guaifenesin with decongestants or other cough-cold actives (format-dependent by country and regulatory status)

The business model relies on “shelf dominance” during winter peaks and on brand extensions that capture multiple consumer segments (daytime vs nighttime use cases, perceived “strength,” and dosing schedules).


What are the key market drivers for MUCINEX revenue growth and decline?

Seasonality and demand elasticity

OTC cough-cold demand is seasonal and weather-sensitive:

  • Demand peaks in winter respiratory seasons in North America and much of Europe.
  • Retail sell-through rises with higher incidence of URIs, but category growth can be offset by shifts toward other symptom-management ingredients.

The elasticity pattern for guaifenesin is usually moderate: consumers trade among “expectorant” options and between combination products, depending on perceived effectiveness and price.

Competitive landscape: branded vs private label

Because guaifenesin is widely available, MUCINEX’s competitive advantage is branding. Competitors include:

  • Branded OTC expectorants using guaifenesin
  • Private-label stores brands and club brands offering guaifenesin at lower unit prices
  • Mix-and-match combination products that pull spend away from single-ingredient expectorants

This creates a market dynamic where:

  • Unit volume may remain stable even when category growth slows.
  • Revenue can still decline if the mix shifts toward lower-priced SKUs or if retailers demand trade spend.

Retailer execution and promotional intensity

In OTC, revenue trajectory is strongly linked to:

  • Slotting, end-cap and holiday promotions
  • Trade spend and consumer coupons
  • Planogram stability for hero SKUs, especially extended-release formats

Margins are typically compressible when retailers negotiate higher promotional funding, particularly for mature OTC brands with generic and private-label pressure.


How strong is the patent and exclusivity position behind MUCINEX guaifenesin?

Does MUCINEX have meaningful exclusivity like an Rx asset?

MUCINEX is a legacy OTC guaifenesin brand. For business modeling:

  • The API (guaifenesin) is not a proprietary driver of exclusivity value in the way modern small molecules are.
  • Brand differentiation typically resides in specific product formulations, dosing regimens, and labeling strategy rather than enforceable “blockbuster” market exclusivity.

What limits IP-driven defensibility

Even if certain formulation or packaging technologies exist, the practical OTC market tends to:

  • Allow rapid entry of generic guaifenesin by ingredient availability and regulatory acceptance.
  • Shift the competitive battlefield to retail economics: price, promo funding, and consumer recognition.

Result: financial trajectory is more sensitive to trade terms and consumer perception than to patent-protected supply restriction.


What product formats drive the financial trajectory of MUCINEX?

Extended-release vs immediate-release economics

In OTC expectorants, extended-release products often support:

  • Higher willingness to pay per dose
  • Better consumer satisfaction narratives (“less frequent dosing”)
  • Easier differentiation vs “plain” guaifenesin generics

Fast-acting formats can win on urgency-based consumer trips but may face steeper price competition.

Combination products: mix-driven margin effects

Combo products can improve revenue per transaction but can also:

  • Increase compliance complexity for consumers
  • Intensify competitive pressure if dominant players pair similar actives
  • Raise scrutiny risk if any component faces regulatory updates

Mix effects often determine whether the brand grows revenue faster than units, which is where profitability turns.


When does MUCINEX typically see peak demand and how does that shape quarterly earnings?

Seasonal pattern used for forecasting

A typical OTC cough-cold brand earnings cadence:

  • Third quarter is usually lower, preparing inventory.
  • Fourth quarter and first quarter include winter peak demand cycles.
  • Promotional calendars often intensify late Q3 into Q4.

This seasonality tends to cause:

  • Concentrated working capital needs in pre-season stocking
  • Inventory management risk when winter intensity is lower than expected

Working capital and supply chain

Seasonal brands can face:

  • Retailer order volatility
  • Inventory write-down risk at the end of peak season
  • Contracting costs that rise in lead-up months

MUCINEX profitability often hinges on how accurately pre-season demand is forecast and how quickly SKUs are rebalanced after retailer sell-through data emerges.


What generic or private-label entry risks exist for MUCINEX?

Primary risk: value migration, not “true replacement”

Because guaifenesin is widely available, entry risks typically show up as:

  • Price erosion through retailer preference for store brand
  • Trade-down from premium branded SKUs to lower-cost SKUs
  • Increased promo frequency by competitors forcing MUCINEX to match incentives

Secondary risk: assortment rationalization

Retailers may reduce facings for slower-moving SKUs and concentrate space on:

  • Best-selling strength/dosing variants
  • Fast-moving combination products
  • Private-label lines that improve retailer margin

Assortment shrinkage can reduce market share even if the category remains stable.


How does MUCINEX compare with other OTC expectorant brands and generics?

Competition categories in cough and cold expectorants

MUCINEX competes against:

  • Branded guaifenesin expectorant products
  • Private-label guaifenesin
  • Other cough actives that shift the consumer perception of cough control (even if not direct substitutes on mechanism)

Comparison outcome typically depends on:

  • Perceived effectiveness and consumer trust
  • Dosing convenience and “strength” framing
  • Price-per-dose under promotion

Business takeaway

For financial trajectory, MUCINEX’s differentiator is “brand + format,” which supports pricing resilience relative to store brand during promos, but cannot fully prevent value migration once category intensity softens.


What does the FDA and OTC monograph landscape mean for MUCINEX?

OTC regulatory environment impact

OTC cough-cold products operate under OTC regulatory frameworks and FDA labeling rules. Business-relevant impacts include:

  • Label updates and safety messaging changes
  • Ingredient review outcomes that can force reformulation or warning changes
  • Manufacturing and quality compliance requirements that affect supply continuity

For MUCINEX, any change in labeling or acceptable use for guaifenesin components would alter packaging, marketing copy, and retailer sell-through.

Commercial effect

Regulatory changes tend to:

  • Trigger temporary distribution slowdowns due to repackaging
  • Increase cost of goods via labeling and compliance updates
  • Increase the burden on manufacturing QA and documentation

What settlement, litigation, or exclusivity events affect MUCINEX commercialization?

Typical OTC litigation profile

Unlike Rx branded drugs, OTC guaifenesin brand disputes usually involve:

  • False advertising, labeling claims, or consumer protection actions
  • Trade dress or marketing claims rather than active ingredient patent enforcement
  • Regulatory or adverse-event related communications

These disputes can disrupt marketing but usually do not create long-term market exclusivity. Financial impacts are typically episodic and cost-based rather than structurally transformative.


How should investors model MUCINEX financial trajectory and profitability?

Key forecasting inputs

For a brand-level OTC model, track:

  1. Category unit demand (URI season intensity proxies)
  2. Share vs price (monitor promo intensity and retail pricing)
  3. Mix (extended-release vs immediate-release; single vs combo)
  4. Net sales per unit under trade promotions
  5. Gross margin after retail allowances and freight
  6. Inventory turns and obsolescence after peak seasons

Margin mechanics

MUCINEX’s gross margin resilience depends on:

  • Formulation and manufacturing cost advantages (or lack of them vs generic suppliers)
  • Retail trade terms demanded by major accounts
  • Ability to maintain premium positioning during peak season

Net margin is more sensitive to promotional intensity and retailer reimbursement rates than to the cost of guaifenesin itself.

Revenue volatility

Expect pronounced year-to-year variability driven by:

  • Winter severity
  • Consumer behavior shifts toward combination products
  • Retail promotions and competitor aggressiveness

Where does MUCINEX revenue come from geographically and by channel?

Channel mix priorities

MUCINEX’s US revenue typically draws from:

  • Mass retail (price and volume focus)
  • Drugstore chains (assortment breadth and frequent shopper traffic)
  • E-commerce and marketplace (promo and search-driven discovery)

Channel conditions impact:

  • Promo depth
  • Returns and allowances
  • Demand visibility and fulfillment economics

International exposure

International markets can differ based on:

  • Product labeling and approved OTC claims
  • Local assortment and brand portfolio strategy
  • Regulatory and manufacturing footprint

The commercial thesis outside the US depends more on distribution partner strength and compliance alignment than on patent exclusivity.


Key Takeaways

  • MUCINEX is an OTC, guaifenesin-based brand where financial trajectory is driven by seasonality, retail execution, and promo intensity rather than patent exclusivity.
  • The strongest revenue supports come from extended-release and mix management, with combination products adding transaction value but increasing competitive and compliance exposure.
  • The main risk is value migration to private label and store brands, which typically compresses net sales per unit via trade-down and deeper promotions.
  • Profitability is governed by trade spend, returns/allowances, inventory discipline, and the ability to protect net price during winter peaks.
  • Regulatory and litigation impacts are usually episodic and labeling/cost based, not structural exclusivity disruptions.

FAQs

1) Is MUCINEX the same as generic guaifenesin, and why does branding matter financially?

MUCINEX is a branded guaifenesin OTC expectorant; branding matters because it influences retailer shelf strategy, consumer selection, and the brand’s ability to command net pricing during seasonal promotions despite ingredient-level generic availability.

2) Which MUCINEX formats typically protect net revenue the best during winter cold season?

Extended-release formats typically support better net revenue resilience because they differentiate on dosing convenience and reduce direct comparability to single-dose generics.

3) What retailer behaviors most affect MUCINEX earnings?

Slotting changes, facing reductions, promo funding demands, and trade-down preferences during category shifts most directly influence net sales and margin.

4) How do shifts to combination cough-cold products impact MUCINEX?

Combination products can raise consumer “bundle” purchasing and increase revenue per trip, but they can also reallocate spend away from single-ingredient expectorants, creating mix-driven volatility.

5) Can regulatory label changes materially change MUCINEX cost structure or sales?

Labeling and OTC compliance updates can require repackaging and marketing changes, creating short-term distribution friction and cost increases, which can temporarily pressure net sales and margins.


References

No sources were provided in the prompt, and none are cited in this response.

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