Last Updated: May 10, 2026

DEXTROMETHORPHAN POLISTIREX - Generic Drug Details


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What are the generic drug sources for dextromethorphan polistirex and what is the scope of freedom to operate?

Dextromethorphan polistirex is the generic ingredient in two branded drugs marketed by Rb Hlth, Amneal, and Tris Pharma Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for dextromethorphan polistirex. Thirty suppliers are listed for this compound.

Summary for DEXTROMETHORPHAN POLISTIREX
US Patents:0
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 30
Raw Ingredient (Bulk) Api Vendors: 30
Patent Applications: 2,503
What excipients (inactive ingredients) are in DEXTROMETHORPHAN POLISTIREX?DEXTROMETHORPHAN POLISTIREX excipients list
DailyMed Link:DEXTROMETHORPHAN POLISTIREX at DailyMed
Medical Subject Heading (MeSH) Categories for DEXTROMETHORPHAN POLISTIREX
Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN POLISTIREX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DELSYM Extended-release Suspension dextromethorphan polistirex 30 mg/5 mL 018658 1 2009-01-12

US Patents and Regulatory Information for DEXTROMETHORPHAN POLISTIREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Tris Pharma Inc DEXTROMETHORPHAN POLISTIREX dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 091135-001 May 25, 2012 OTC No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal DEXTROMETHORPHAN POLISTIREX dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 203133-001 Jul 28, 2017 OTC 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

Expired US Patents for DEXTROMETHORPHAN POLISTIREX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 ⤷  Start Trial ⤷  Start Trial
Rb Hlth DELSYM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018658-001 Oct 8, 1982 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Dextromethorphan Polistirex: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

How big is the market and where does it sit in the value chain?

Dextromethorphan polistirex is an extended-release antitussive positioned for cough suppression. In most geographies, it is sold primarily through retail pharmacy channels as an OTC or behind-the-counter product depending on local regulation, with price formation driven by (1) generic availability, (2) shelf-size economics and pharmacy formulary practices, and (3) whether competitors are also branded or depend on extended-release profiles.

In practical market terms, dextromethorphan polistirex participates in the “cold and cough” segment where:

  • Volume growth is modest and cyclical, tied to seasonal respiratory illness patterns.
  • Value growth is constrained by generic penetration and intense competitive price pressure.
  • Product differentiation relies on formulation (extended-release behavior), packaging, and channel execution rather than clinical novelty.

Financially, this structure typically produces a trajectory characterized by:

  • Early brand-led uptake, followed by margin compression after generic entry.
  • Earnings volatility driven by seasonal demand and promotion intensity.
  • Low R&D capitalization in later lifecycle stages because formulation and manufacturing process are the main levers, not new mechanism innovation.

What drives demand for dextromethorphan polistirex?

Key demand drivers are operational and seasonal:

  1. Seasonality of respiratory infections

    • Cough prevalence increases during fall and winter waves, shifting monthly demand and inventory cycles.
  2. Substitution within antitussives

    • Extended-release dextromethorphan competes with other antitussive formats (immediate-release dextromethorphan, combination cold products, and alternative actives depending on local availability).
    • Consumers and retailers favor price and availability, pushing consistent substitution once multiple equivalent options exist.
  3. Regulatory and labeling

    • Dextromethorphan is used widely across OTC cough indications with labeling that governs age eligibility, contraindications, and dosing.
  4. Channel economics

    • Retail and managed care tend to favor lowest net cost for therapeutically substitutable SKUs, especially post-generic entry.

How have market dynamics changed over time?

Dextromethorphan polistirex has followed a typical lifecycle pattern for non-NME cough therapies:

  • Pre-generic phase: branded positioning supports higher wholesale and retail price realization.
  • Post-generic phase: pricing converges toward competitive benchmarks, increasing SKU count but compressing gross margins.
  • Late phase: remaining differentiation focuses on extended-release consistency, packaging, and supply reliability.

This creates a finance profile where companies with manufacturing scale and strong distribution win share during seasonal peaks, while smaller entrants face stronger margin pressure and inventory risk.

What is the competitive landscape and how does it impact pricing?

The competitive set is dominated by:

  • Generic extended-release dextromethorphan products (typically multiple manufacturers and labelers).
  • OTC cough combination products containing dextromethorphan.
  • Alternative antitussives and symptom-relief products depending on local formulary and consumer preference.

Pricing impact:

  • Generic competition forces net price compression and promotes trade-down to lower-cost equivalents.
  • Competition intensifies during respiratory seasons because manufacturers and retailers compete for shelf space and promotional slots.

Net effect on financials:

  • Revenue tends to be more dependent on unit volume than on price once generic penetration is high.
  • Operating margin depends heavily on manufacturing cost control and working-capital discipline (inventory and receivables).

What does the regulatory and patent framework imply for cash flows?

Dextromethorphan polistirex is not positioned as a long-running IP moat in the way biologics or disease-modifying therapeutics are. For small-molecule antitussives, cash flow implications typically follow:

  • Broad formulary access post-approval and post-brand exclusivity.
  • Predictable revenue but limited price protection once patents expire or are not enforceable against competitors.
  • Lower probability of sustained blockbuster pricing because the therapeutic area is symptomatic care with substitute products.

The core financial lever therefore becomes manufacturing scale and distribution.

What is the expected financial trajectory across lifecycle stages?

A realistic trajectory for dextromethorphan polistirex in established markets is:

1) Growth stage (brand or limited competition)

  • Revenue expands with brand adoption and retail distribution.
  • Margin profile is stronger because price realization exceeds cost plus normal distribution spreads.

2) Transition stage (generic entry and mix shift)

  • Revenue growth slows as net price declines.
  • Volume may hold or grow due to substitution, but gross margin compresses.
  • Increased marketing and trade spending reduces operating margin.

3) Maturity stage (high competition)

  • Revenue becomes seasonal and volume-driven.
  • EBITDA margins stabilize but remain pressured by price competition and promotional intensity.
  • Operational focus shifts to supply chain efficiency, forecasting accuracy, and SKU rationalization.

How do seasonal dynamics translate into operating performance?

Because cough incidence is seasonal, quarterly results for cough therapies often show:

  • Higher revenue and lower relative SG&A as a percentage in winter and early cold seasons due to absorption of fixed costs.
  • Working-capital fluctuations driven by pre-season inventory builds and post-season clearing promotions.

For businesses exposed to these dynamics, earnings quality depends on the ability to:

  • Forecast demand by region and channel.
  • Avoid over-inventory that triggers end-of-season markdowns.

What are the likely manufacturing and distribution economics?

For extended-release oral antitussives, economics are typically shaped by:

  • Raw material costs and polymer-based formulation consistency.
  • Manufacturing yield and batch-to-batch release profile control.
  • Scale economies across multiple SKUs or labelers.
  • Distribution reach and contract manufacturing arrangements.

Financially, this is usually less sensitive to clinical endpoints and more sensitive to:

  • Cost of goods sold (COGS).
  • Supply continuity.
  • Compliance and batch release costs.

What does this mean for investor or business decision-making?

For R&D planning and investment underwriting, the market and financial logic points to the following actionable framing:

Underwrite revenue

  • Expect revenue growth to track seasonal unit demand and channel penetration rather than premium pricing.
  • Model sensitivity to competitive promotional intensity during peak cough season.

Underwrite margin

  • Treat margin as a function of:
    • COGS control,
    • product mix (branded vs generic vs combination),
    • and trade spend intensity.

Underwrite cash flow

  • Focus on working capital cycles around seasonal inventory.
  • Stress-test inventory and receivables for post-season clearance risk.

R&D and lifecycle strategy

  • In late stage, incremental value creation usually comes from manufacturing improvements, line extensions (packaging, dosing, age labeling where permissible), and regulatory strategy rather than new clinical differentiation.

How does this product’s market behavior compare to other symptomatic cough therapies?

Across symptomatic cough categories, the typical pattern is:

  • Higher substitution risk and limited payer differentiation.
  • Price competition as the dominant commercial force.
  • Shelf and channel execution matter more than payer coverage decisions in OTC-heavy settings.

Dextromethorphan polistirex aligns with this behavior, with the extended-release attribute providing only limited long-term price protection once alternatives exist.

Key regulatory and product references that shape the market

The dextromethorphan polistirex active ingredient is recognized in FDA labeling and consumer-facing product labeling frameworks for cough suppression. Standard OTC cough labeling requirements constrain dosing, age indications, and contraindications, affecting market access and consumer adoption patterns. The FDA’s drug labeling and approved product information frameworks govern how products compete on claims and dosing instructions. (See FDA resources on drug labeling and approval status: [1], [2].)

Market risk map

The financial trajectory is most sensitive to these risk factors:

  • Price compression from generic entry
  • Seasonality forecast error
  • Inventory markdown risk after demand normalizes
  • Competitive promotional intensity at retail
  • Manufacturing disruptions that affect supply continuity during peak seasons

Key Takeaways

  • Dextromethorphan polistirex sits in a seasonal, substitutable OTC/symptomatic cough market where unit volume drives revenue more than price.
  • High generic availability compresses margins after the initial brand-lift phase, leaving operating performance dependent on COGS control and inventory discipline.
  • Financial trajectory typically follows a lifecycle pattern: growth with brand exclusivity, margin compression on generic entry, then maturity characterized by seasonal EBITDA stability with working-capital volatility.
  • The extended-release format can support consumer preference early, but long-term price protection is limited once competitive formats and generics expand.
  • Business and investment underwriting should prioritize seasonal demand modeling, promotional intensity sensitivity, and working-capital stress tests over clinical differentiation assumptions.

FAQs

1) What primarily drives revenue for dextromethorphan polistirex?

Unit demand tied to seasonal cough incidence and retail channel penetration. Post-generic, net price realization declines and revenue relies more on volume.

2) Why do margins compress over time?

Generic and alternative antitussive formats increase substitution, forcing net price competition and higher trade spending.

3) What is the main source of cash flow volatility?

Working-capital swings around pre-season inventory builds and post-season inventory clearance.

4) Does extended-release meaningfully protect pricing long term?

It can support preference and mix in early periods, but it usually does not prevent pricing convergence once generic extended-release supply is broad.

5) How should forecasts be structured for this product category?

Separate seasonality-driven volume assumptions from net price assumptions, then model trade spend and inventory markdown risk in peak versus post-peak periods.


References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug labeling (Drugs@FDA and related resources). FDA. https://www.fda.gov/drugs
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drug products. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/

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