DELSYM Drug Patent Profile

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

Delsym is a drug marketed by Rb Hlth and is included in one NDA.

The generic ingredient in DELSYM is dextromethorphan polistirex. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Delsym

A generic version of DELSYM was approved as dextromethorphan polistirex by TRIS PHARMA INC on May 25^th, 2012.

Summary for DELSYM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	5
Patent Applications:	1,343
Drug Prices:	Drug price information for DELSYM
What excipients (inactive ingredients) are in DELSYM?	DELSYM excipients list
DailyMed Link:	DELSYM at DailyMed

See drug prices for DELSYM

See drug sales revenues for DELSYM

Recent Clinical Trials for DELSYM

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

Sponsor	Phase
University of Southern California	Phase 4
Takeda	Phase 4
The Johns Hopkins Institute for Clinical and Translational Research (ICTR)	Phase 2

See all DELSYM clinical trials

Pharmacology for DELSYM

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

Paragraph IV (Patent) Challenges for DELSYM

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 DELSYM

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

Expired US Patents for DELSYM

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

International Patents for DELSYM

See the table below for patents covering DELSYM around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2234282	COMPLEXES MEDICAMENT/RESINE STABILISES PAR DES CHELATEURS (DRUG-RESIN COMPLEXES STABILIZED BY CHELATING AGENTS)
European Patent Office	0911039

Supplementary Protection Certificates for DELSYM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
1539166	2013/055	Ireland		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166	CR 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624

DELSYM Market Analysis and Financial Projection Experimental

Delsym and the Dextromethorphan Market: Understanding Market Dynamics and Financial Trajectory

Market Overview of Dextromethorphan

The dextromethorphan market, which includes products like Delsym, is poised for stable growth driven by several key factors. Here are some critical aspects of the market dynamics and financial trajectory.

Market Size and Growth Projections

The global dextromethorphan market was valued at USD 487.25 million in 2022 and is expected 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][3][5].

Key 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 significant driver of the market. Dextromethorphan, commonly used as an over-the-counter cough suppressant, sees increased demand due to these conditions[1][3][5].

Growing Consumer Awareness and Self-Medication

Increased access to healthcare information and the trend towards self-medication practices have led consumers to seek relief from cough symptoms using over-the-counter medications like dextromethorphan. This shift towards self-medication is a major growth driver[1][3][5].

Growing Investment in Healthcare Facilities

The expansion and investment in healthcare facilities, particularly in regions like North America and Asia-Pacific, also contribute to the market's growth. These investments include research activities and the establishment of new healthcare infrastructure[1][3].

Market Segmentation

By Product Type

The market is dominated by over-the-counter (OTC) products, which account for the largest share due to high consumer demand. Prescription drugs also form a part of the market but are less prevalent compared to OTC products[1].

By Dosage Form

Dextromethorphan is available in various dosage forms, including syrups, tablets, and other forms. Syrups, particularly extended-release oral suspensions like Delsym, are popular due to their ease of use and effectiveness[1][3].

By Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, online pharmacies, and others. Retail pharmacies are a major distribution channel due to their widespread presence and consumer preference[1][3].

Regional Analysis

North America

North America is the largest market for dextromethorphan, driven by a strong base of healthcare facilities, a high incidence of flu and cold cases, and a trend towards self-medication. The region's market growth is also fueled by ongoing research into broader applications of dextromethorphan[1][3][5].

Asia-Pacific

The Asia-Pacific region is expected to witness significant growth due to government initiatives promoting healthcare awareness, an increase in healthcare facilities, and a large population pool. This region offers substantial untapped markets and growing demand for quality healthcare[1][3][5].

Major Players and 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 innovation and product launches[1][3][5].

Recent Developments: Generic Alternatives to Delsym

A significant recent development is the approval of the first-ever generic to Delsym by Tris Pharma. This generic version, distributed exclusively by Perrigo, is expected to provide a cost-effective alternative to the brand-name product, potentially impacting market dynamics and consumer choices[2].

Financial Impact of Generic Alternatives

The introduction of generic alternatives can lead to increased competition and potentially lower prices. For instance, the generic version of Delsym is priced around $11.56 for 89 milliliters, compared to the brand-name product which costs around $20 for the same quantity[2][4].

Challenges and Restraints

Side Effects Associated with Dextromethorphan

Despite the growth prospects, the market faces challenges from side effects associated with dextromethorphan. These side effects can restrain market expansion and influence consumer preferences towards alternative treatments[1][3][5].

Key Takeaways

• The global dextromethorphan market is projected to grow at a CAGR of 4.8% from 2023 to 2030.
• North America dominates the market, while Asia-Pacific is expected to witness significant growth.
• Over-the-counter products and syrups are the dominant segments.
• Major players include AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical.
• The introduction of generic alternatives, such as the generic to Delsym, is expected to impact market dynamics.
• Side effects associated with dextromethorphan are a significant restraint to market growth.

FAQs

What is the current market size of the dextromethorphan market?

The dextromethorphan market was valued at USD 487.25 million in 2022 and is expected to reach USD 587.31 million by 2030[1].

Who are the key players in the dextromethorphan market?

Key players include AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical[1][3][5].

Which region has the largest share in the dextromethorphan market?

North America accounts for the largest market share in the dextromethorphan market[1][3][5].

What is the impact of generic alternatives on the dextromethorphan market?

Generic alternatives, such as the generic to Delsym, can increase competition and potentially lower prices, affecting consumer choices and market dynamics[2][4].

What are the major drivers of the dextromethorphan market?

The major drivers include the increasing prevalence of cough-related conditions, growing consumer awareness and self-medication, and growing investment in healthcare facilities[1][3][5].

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. Mordor Intelligence: Dextromethorphan Market Size - Mordor Intelligence.
4. Drugs.com: Delsym Prices, Coupons, Copay Cards & Patient Assistance.
5. Mordor Intelligence: Dextromethorphan Market Size & Share Analysis - Growth Trends.