Dextromethorphan polistirex - Generic Drug Details

What are the generic 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

Pharmacology for dextromethorphan polistirex

Drug Class	Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for dextromethorphan polistirex

Antitussive Agents

Excitatory Amino Acid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for dextromethorphan polistirex

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

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
Amneal	DEXTROMETHORPHAN POLISTIREX	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	203133-001	Jul 28, 2017		OTC	No	No
Tris Pharma Inc	DEXTROMETHORPHAN POLISTIREX	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091135-001	May 25, 2012		OTC	No	No

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	4,221,778
Rb Hlth	DELSYM	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	018658-001	Oct 8, 1982	5,980,882

Market Dynamics and Financial Trajectory for Dextromethorphan Polistirex

Last updated: February 13, 2026

Dextromethorphan polistirex (DMP) is an extended-release formulation used primarily as an antitussive to suppress coughs. It is delivered as an oral suspension or tablet, often in combination products for cold and cough relief. The product's market presence stems from its inclusion in over-the-counter (OTC) medicines, with some prescription applications depending on regional regulations.

Market Overview

The global cough and cold remedies market, valued at approximately $9.7 billion in 2022, projects an annual growth rate of 3-4% through 2030. Key drivers include increased consumer demand for OTC remedies, rising prevalence of respiratory infections, and expanding regional markets, particularly in Asia-Pacific.

Dextromethorphan (DXM), the active ingredient within DMP, enjoys widespread recognition. Its extended-release form, polistirex, offers sustained cough suppression, enhancing its attractiveness for prolonged symptom management.

Market Segments & Regional Distribution

• OTC Sector: Dominates the market, with DMP marketed as a standalone or combination product.
• Prescription Segment: Limited, mainly for cases requiring controlled dosing to prevent misuse.
• Regional Markets: U.S., Europe, and Asia-Pacific account for 75% of sales, driven by regulatory environments and consumer preferences.

Regulatory Landscape

Regulatory bodies tightly control DXM formulations due to abuse potential. In the U.S., the Substance Abuse and Mental Health Services Administration (SAMHSA) monitors products containing DXM, with some states imposing purchase limits or age restrictions.

In Europe, regulations vary; some countries classify DMP as a pharmacy-only medication, limiting OTC sales.

Market Drivers & Challenges

Drivers:

• Increasing respiratory illness incidence.
• Growing aging population prone to chronic cough.
• Consumer preference for extended-release formulations, driven by convenience.

Challenges:

• Abuse potential leading to criminal restrictions.
• Competition from alternative antitussives, such as codeine or new synthetic agents.
• Regulatory hurdles, especially concerning sales restrictions and scheduling.

Competitive Landscape

Market players include Johnson & Johnson (Vick’s Formula 44), Glenmark, and Perrigo. These companies develop products that incorporate DMP, often in combination with antihistamines or decongestants.

The market exhibits moderate competition with innovation focused on formulation improvements to reduce misuse and improve bioavailability.

Financial Trajectory

Revenue Estimates:
Based on sales data from OTC cough remedies, DMP-containing products contribute approximately $300-500 million annually worldwide. The segment for extended-release formulations like polistirex is a subset of this, estimated at $50-120 million.

Growth Potential:
A compound annual growth rate (CAGR) of 4-5% is projected over the next five years, driven by new product launches, market expansion in emerging economies, and regulatory easing in some regions.

Profitability:
Gross margins for OTC cough suppressants averaging 40-50%, with extended-release formulations potentially commanding premium pricing due to convenience and dosing accuracy.

Research & Development Investment:
Major companies invest in reformulation for improved abuse deterrence or combination therapies, though high regulatory costs and patent expiration pressures influence profit margins.

Intellectual Property & Patent Trends

Patent expirations over the last decade for key DXM formulations have opened market access and prompted generic competition. Companies focus on novel delivery systems, abuse-deterrent technologies, and combinatory products to sustain market share.

Conclusion

The DMT polistirex market will grow steadily, influenced by respiratory disease prevalence and consumer preference for extended-release formulations. Regulatory developments remain a key risk factor, especially in markets sensitive to abuse potential. Innovation in formulations and combination products will sustain competitive advantage and profitability.

---

Key Takeaways

• The global cough remedy market is growing modestly, with Dextromethorphan Polistirex as a significant contributor within OTC segments.
• Regulatory controls influence sales and formulation strategies, with abuse mitigation efforts driving innovation.
• Revenue estimates suggest a global market contribution of approximately $50-120 million for DMP in extended-release forms, with moderate growth prospects.
• Competing formulations and regulatory challenges shape the future landscape, emphasizing formulation innovation and geographic expansion.
• Intellectual property strategies are pivotal, with patent expirations prompting focus on abuse-deterrent technologies.

---

FAQs

1. What factors influence the market share of dextromethorphan polistirex?
   Market share depends on regulatory restrictions, consumer demand for extended-release formulations, and competition from alternative cough suppressants.

2. How does regulation affect sales in different regions?
   In regions like the U.S., regulation by agencies like the FDA and SAMHSA limits sales due to abuse potential, impacting revenue. European markets vary, with some countries restricting OTC sales.

3. What are the main competitors in this segment?
   Johnson & Johnson and Perrigo dominate, focusing on formulations that blend DMP with other active ingredients or incorporate abuse-deterrent features.

4. What is the outlook for innovation in dextromethorphan formulations?
   Research targets abuse-deterrent technology, sustained delivery systems, and combination therapies to sustain market relevance.

5. How do patent expirations impact the market?
   Expired patents lead to increased generic competition, reducing prices and profit margins unless offset by product differentiation or new formulations.

---

References

1. IBISWorld. "Cough and Cold Medicine Manufacturing in the US," 2022.
2. Grand View Research. "Over-the-Counter (OTC) Drugs Market Size, Share & Trends," 2023.
3. FDA. "Regulatory Status of Dextromethorphan," 2022.
4. WHO. "Global Burden of Respiratory Diseases," 2021.
5. NICE. "Guidelines on Cough Management," 2022.