DEXTROMETHORPHAN POLISTIREX - Generic Drug Details

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. Twenty-eight 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:	28
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	1,952
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
Tris Pharma Inc	DEXTROMETHORPHAN POLISTIREX	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091135-001	May 25, 2012		OTC	No	No
Amneal	DEXTROMETHORPHAN POLISTIREX	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	203133-001	Jul 28, 2017		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
Rb Hlth	DELSYM	dextromethorphan polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	018658-001	Oct 8, 1982

DEXTROMETHORPHAN POLISTIREX Market Analysis and Financial Projection Experimental

Dextromethorphan Polistirex Market Dynamics and Financial Trajectory

Market Overview

Dextromethorphan polistirex, a cough suppressant commonly used in over-the-counter (OTC) medications, is a significant player in the global pharmaceutical market. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global dextromethorphan market, which includes dextromethorphan polistirex, was valued at USD 487.25 million in 2022. It is projected to reach USD 587.31 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.8% during the forecast period of 2023 to 2030[1].

Drivers of Market Growth

Increasing Prevalence of Cough Related Conditions

The rising prevalence of respiratory conditions such as the common cold, flu, bronchitis, and allergies is a major driver of the market. These conditions lead to an increased demand for cough medications, thereby boosting the sales of dextromethorphan polistirex[1][3][4].

Growing Consumer Awareness and Self Medication

Increased access to healthcare information and the trend towards self-medication have made consumers more aware of OTC medications like dextromethorphan. This awareness has led to higher sales as individuals seek relief from cough symptoms through self-medication[1][4].

Growing Investment in Healthcare Facilities

Investments in healthcare facilities, particularly in regions like North America and Asia-Pacific, have also contributed to the market growth. These investments include research activities and the expansion of healthcare services, which in turn increase the demand for dextromethorphan polistirex[1][3].

Regional Market Performance

North America

North America dominates the global dextromethorphan market due to a strong base of healthcare facilities, a significant presence of major market players, and a high incidence of flu and cold cases, especially among the geriatric population[1][3][4].

Asia-Pacific

The Asia-Pacific region is expected to witness significant growth due to government initiatives promoting healthcare awareness, the rise in healthcare facilities, and a large population pool. This region offers substantial untapped markets and growing demand for quality healthcare[1][3].

Product Type and Dosage Form

Over-the-Counter (OTC) Dominance

The OTC segment dominates the product type segment of the global dextromethorphan market due to high demand for these products. Dextromethorphan polistirex is often available in extended-release oral suspension forms, which are popular for their convenience and effectiveness[1][2].

Extended-Release Dosage Forms

The approval of the first-ever generic to Delsym, an extended-release oral liquid suspension containing dextromethorphan polistirex, by Tris Pharma marks a significant development. This product, distributed exclusively by Perrigo, is expected to be a major player in the market, especially during the cough/cold/flu season[2].

Distribution Channels

The market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, online pharmacies, and others. Retail pharmacies are a key distribution channel, given the widespread availability and ease of access to OTC medications like dextromethorphan polistirex[1][4].

Challenges and Restraints

Side Effects Associated with Dextromethorphan

Despite the market's growth prospects, it faces challenges from the side effects associated with dextromethorphan, such as drowsiness, dizziness, and stomach upset. These side effects can restrain the market's expansion over the forecast period[4].

Competitive Landscape

The dextromethorphan market is characterized by the presence of both international and local companies. Key players include AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical. These companies contribute to the market's dynamic nature through continuous innovation and product development[4].

Financial Performance and Projections

• Annual Sales: The entire Delsym brand, which includes dextromethorphan polistirex products, generates annual sales of more than $100 million[2].
• Market Size Projections: By 2030, the global dextromethorphan market is expected to reach USD 587.31 million, with a CAGR of 4.8% during the forecast period[1].
• Long-Term Growth: The market is projected to exceed USD 685.12 million by the end of 2036, with a CAGR of over 4.3% during the period from 2024 to 2036[3].

Key Takeaways

• The global dextromethorphan market is driven by the increasing prevalence of respiratory conditions and growing consumer awareness of OTC medications.
• North America and Asia-Pacific are key regions driving market growth.
• Extended-release dosage forms, such as dextromethorphan polistirex, are gaining popularity.
• Despite growth prospects, the market faces challenges from side effects associated with dextromethorphan.
• The competitive landscape is dynamic, with major players continuously innovating and expanding their product portfolios.

FAQs

What is the current market size of the global dextromethorphan market?

The global dextromethorphan market was valued at USD 487.25 million in 2022[1].

Who are the major players in the dextromethorphan market?

Major players include AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical[4].

What is the expected CAGR of the global dextromethorphan market from 2023 to 2030?

The market is expected to grow at a CAGR of 4.8% during the forecast period of 2023 to 2030[1].

What are the primary drivers of the dextromethorphan market?

The primary drivers include the increasing prevalence of cough-related conditions and growing consumer awareness and self-medication practices[1][3][4].

Which region is expected to witness significant growth in the dextromethorphan market?

Asia-Pacific is expected to witness significant growth due to government initiatives, rising healthcare facilities, and a large population pool[1][3].

Cited Sources

1. Data Bridge Market Research: Global Dextromethorphan Market Size, Scope, Growth, Value & Statistics.
2. Tris Pharma: Tris Pharma Announces Approval of First-Ever Generic to Delsym.
3. Research Nester: Dextromethorphan Market Size, Growth Forecasts 2024-2036.
4. Mordor Intelligence: Dextromethorphan Market Size - Mordor Intelligence.