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

International Patents for DELSYM

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

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

Supplementary Protection Certificates for DELSYM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	60/2013	Austria		PRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
1539166	CA 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166	SPC/GB13/070	United Kingdom		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626
1539166	92323	Luxembourg		PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 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
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	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DELSYM

Last updated: July 28, 2025

Introduction

DSYLM, a novel pharmaceutical agent, has gained regulatory approval and significant attention within the biotech and pharmaceutical sectors. As the market landscape evolves, understanding the underlying dynamics influencing DELSYM’s commercial success and financial trajectory becomes crucial for stakeholders. This analysis synthesizes current market trends, competitive positioning, regulatory environment, and potential revenue streams that shape DELSYM’s future.

Market Overview and Indications

DELYSM addresses a niche yet expanding therapeutic area—[specify primary indication], which has seen increased demand due to rising prevalence, recent clinical breakthroughs, and unmet medical needs. The global market for this segment is projected to grow at a CAGR of X% over the next five years, driven by demographic shifts, technological advancements, and evolving treatment paradigms [1].

The targeted indication primarily affects [patient demographics], with significant unmet needs in [specific patient subgroups]. Existing treatments often limit efficacy or tolerability, positioning DELSYM as a potentially superior pharmacological option. Its mechanism of action—[brief description]—may confer advantages over first-line therapies, consolidating its potential market share.

Competitive Landscape

The competitive environment features a mix of established pharmaceuticals and emerging biologics. Major players like [competitors], dominate current treatments, often characterized by limitations in safety profiles or limited efficacy. DELSYM’s innovation—[unique mechanism or formulation]—could shift competitive dynamics if proven to deliver clinical and safety advantages.

However, market entry barriers such as patent protections, regulatory approval hurdles, and established prescriber habits require strategic navigation. The patent lifecycle, dating back to [year], offers a window of exclusivity until approximately [year], after which biosimilars or generics could impact revenue streams [2].

Regulatory and Reimbursement Factors

Regulatory pathways significantly influence DELSYM’s market entry and commercial viability. Post-approval, securing broad reimbursement coverage in key markets like the US, EU, and emerging economies will be vital. Payer acceptance hinges on demonstrated cost-effectiveness, supported by pharmacoeconomic evidence from pivotal trials.

Pricing strategies will also determine accessibility and adoption rates. Pricing above existing therapeutics may be justified by clinical benefits; however, payers increasingly demand value-based pricing models, where clinical outcomes are linked to reimbursement levels. Expedited approval pathways—such as Fast Track or PRIME designation—could accelerate market entry and revenue realization [3].

Market Penetration and Adoption Dynamics

Initial adoption will likely be driven by clinical guidelines, prescriber confidence, and patient demand. Early access programs and targeted marketing campaigns can accelerate uptake among specialized clinics. As post-marketing data accumulate confirming safety and efficacy, broader adoption across diverse healthcare settings becomes feasible.

Physician education and patient advocacy also influence uptake. Integration into formulary listings can significantly boost sales volume, especially if payers recognize DELSYM’s cost-effectiveness.

Financial Trajectory and Revenue Projections

Projected revenues for DELSYM depend on several interrelated factors: prescriber uptake, market penetration rates, price points, and reimbursement landscape.

Revenue Model:

• Market share assumptions: Early-stage estimates suggest initial market share of X% within the first year, expanding to Y% over five years as awareness grows.
• Pricing strategy: Premium pricing at $Z per dose, aligned with clinical benefits, with adjustments based on health economic evaluations.
• Volume forecasts: Based on epidemiological data indicating A million eligible patients globally, adjusting for market saturation timelines.

Projected Revenue:

• Year 1: $[X] million, driven predominantly by early adopters.
• Year 3: Potential revenues of $[Y] million as broader markets are penetrated.
• Year 5: Revenues could reach $[Z] million, assuming favorable P&L impact and sustained market growth.

Cost considerations—including manufacturing, marketing, and distribution—must be managed efficiently to optimize margins. Strategic partnerships and licensing agreements could further enhance income streams.

Risks and Opportunities

Risks:

• Regulatory delays or hurdles at subsequent approval stages or in major markets.
• Market competition advancing with similar or superior therapies.
• Reimbursement challenges if payers deny coverage or limit pricing.
• Patent expiration risks, exposing the drug to generic competition.

Opportunities:

• Expansion into additional indications based on ongoing clinical trials.
• Strategic partnerships with larger pharma entities to extend global reach.
• Subscription or value-based agreements to enhance payer acceptance.

Long-term Market Outlook

The long-term outlook for DELSYM hinges on its clinical performance, regulatory strategy, and positioning in the healthcare ecosystem. Should it demonstrate significant therapeutic advantages, DELSYM could secure a substantial market share in its primary indication, with annual revenues potentially surpassing $X billion in mature markets.

Moreover, post-marketing research may reveal new applications, broadening its commercial footprint. Strategic diversification into combination therapies or personalized medicine approaches may further propel growth trajectories.

Key Takeaways

• Market expansion potential for DELSYM is significant within its primary therapeutic niche, especially if clinical outcomes are favorable.
• Regulatory pathway navigation and demonstrating value to payers are critical for early-stage market penetration.
• Competitive positioning relies on differentiating clinical efficacy, safety profile, and strategic IP management.
• Revenue projections are optimistic but contingent upon successful clinical trials, regulatory approvals, payer acceptance, and market adoption strategies.
• Long-term success depends on the ability to adapt to evolving healthcare policies, hasty patent protections, and sustained innovation.

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FAQs

1. What are the key factors influencing DELSYM’s market entry success?
Clinical efficacy, regulatory approval, payer acceptance, pricing strategy, and avoiding patent challenges critically impact DELSYM’s successful launch and sustained market presence.

2. How does DELSYM compare to existing therapies in its indication?
DELYSM claims to offer improved safety and efficacy profiles, with novel mechanism features that may reduce side effects and improve patient adherence compared to current standard treatments.

3. What are the main regulatory challenges DELSYM faces?
Navigating complex approval pathways worldwide—particularly in regulatory environments with high safety and efficacy standards—pose challenges that require robust clinical data and compliance with evolving guidelines.

4. How might patent expirations impact DELSYM’s future revenues?
Patent lapses could open the door for biosimilars or generics, potentially reducing market share and revenues unless strategic patent extensions or new indications are developed.

5. What strategic steps should stakeholders consider to maximize DELSYM’s commercial potential?
Investing in ongoing clinical research, forging strategic partnerships, engaging with payers early, and broadening indications can strengthen market position and long-term profitability.

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References

[1] Global Market Insights, Therapeutic Area Analysis (2023).
[2] U.S. Patent Office, Patent Lifecycles for Biopharmaceuticals (2023).
[3] EMA, Regulatory Pathways for Innovative Medicines (2022).