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. Thirty 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:	2
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
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	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
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
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	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	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

DELSYM: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is DELSYM and where does it sell?

DELSYM is an antitussive brand line positioned for treatment of cough. In the U.S., it is sold as an OTC cough product under the Reckitt portfolio (Delsym is a Reckitt brand). Its market exposure is driven by:

• U.S. OTC cough demand cycles (winter respiratory seasonality)
• Pharmacy and mass channel distribution
• Competitive substitution against other OTC cough-and-cold products
• Price/mix swings from private label and multi-symptom formats

Brand/product anchor

• DELSYM is marketed in cough formulations (including extended-release cough products) in the U.S. OTC market (Reckitt brand ownership and marketing presence) [1].

How does the OTC cough market drive DELSYM volumes?

DELSYM’s unit movement tracks the broader OTC cough category, which typically expands in colder months and tightens during warmer periods. Key dynamics shaping demand and re-ordering patterns:

Seasonality and promotional cycles

• Demand spikes: late fall through winter due to respiratory viral prevalence and cold-weather spread dynamics.
• Promotional intensity: retailers increase trade spending in peak months; brands respond with price promotions, display allowances, and bundling.

Category shift to fewer, stronger symptom claims

Cough products compete against:

• Multi-symptom combinations (cough plus congestion or pain/fever)
• Suppressant/expectorant differentiation (dosing convenience and perceived onset)
• Private label alternatives with aggressive shelf pricing

DELSYM’s positioning as a cough-focused product supports shelf relevance when consumers want targeted therapy rather than combination therapy.

What pricing forces affect DELSYM’s financial trajectory?

DELSYM’s financial path is shaped by four pricing levers:

1. Retail list price and trade-down

   • List prices rise with commodity and freight costs, but net realized pricing can compress due to retailer promotions and couponing.

2. Private label and store-brand encroachment

   • Store brands often undercut national brands in commodity-like OTC categories, creating margin pressure unless brand pricing resists through value messaging and formulation differentiation.

3. Channel mix

   • Growth in mass or club formats can pressure price per unit but raise volume.
   • Pharmacy channels can support higher net pricing but face intense competitive shelf rotations.

4. Formulation and regimen economics

   • Extended-release formats can support higher price per unit and reduce dosing frequency, which can defend willingness to pay during peak cough seasons.

Where does competition squeeze DELSYM?

DELSYM competes in the broader cough and cold shelf with:

• Other OTC antitussives (including dextromethorphan-based alternatives)
• Expectorants and cough suppressants in combination formats
• Multi-symptom products that bundle cough with additional actives

The OTC market’s substitution risk is structurally high: consumers may switch within the same symptom set (cough) based on price, package format, and perceived speed.

How does DELSYM’s ownership influence financial reporting and trajectory?

DELSYM is a Reckitt brand. Reckitt’s financials are reported across product lines rather than single-brand P&Ls, so market trajectory for DELSYM is inferred from brand presence, segment performance, and OTC category conditions.

Reckitt’s reporting context

• Reckitt is the owner/marketer of Delsym in the U.S. OTC market [1].
• Reckitt’s Consumer Health and related portfolios sit within a broader multinational OTC platform where category seasonality and promo cycles influence quarterly revenue patterns.

What are the measurable financial trajectory signals for DELSYM?

Public filings typically do not disclose DELSYM-specific revenue or segment margin. The financial trajectory is therefore read through:

• Reckitt’s overall Consumer Health performance trends during cough seasons
• OTC category retail sell-through behavior
• Pricing and promotional intensity in cough products

Operational reality

• For OTC cough products, revenue tends to show pronounced seasonality with:
  • Highest sell-through in Q4 and Q1 (U.S. winter season)
  • Lower demand in Q2 and Q3 (post-season decline)

How do market dynamics typically affect quarterly revenue phasing?

A practical quarterly model for cough-focused brands like DELSYM:

• Q4 (peak ramp): increasing prescriptions for cough products and stronger retail replenishment. Promo activity increases to lock in shelf share before winter.
• Q1 (peak): highest consumer demand and largest sell-through volume.
• Q2 (post-peak normalization): volumes soften; manufacturers adjust inventory and reduce promo pressure to protect net pricing.
• Q3 (baseline): trough demand period; growth depends more on incremental share, channel expansion, and pack/formulation preference rather than seasonality.

The same pattern applies unless a major competitive event changes shelf dynamics or a supply disruption affects availability.

What events could materially change DELSYM’s trajectory?

For OTC cough brands, major trajectory drivers usually fall into two buckets:

1) Competitive and regulatory shelf changes

• Reformulations by competitors
• New OTC entrant promotions
• Any regulatory labeling shifts that change consumer perception or allowable claims

2) Supply and cost shocks

• Raw material inflation
• Logistics and packaging cost shifts
• Manufacturing capacity constraints that limit fill rates during peak demand

Even without public DELSYM-only financial reporting, these shocks tend to show up as category-level volatility (pricing, promotional intensity, and retailer ordering swings).

What is the investment-relevant view of DELSYM’s economics?

For a brand like DELSYM, investor-grade economics hinge on whether the brand maintains:

• Share stability: does it lose shelf presence during private-label and multi-symptom promotions?
• Net pricing resilience: does brand pricing offset discounting in peak months?
• Mix advantage: does extended-release or differentiated packaging sustain higher realized pricing?

If DELSYM holds share and maintains net pricing discipline, revenue can remain resilient even if category units fluctuate.

What is DELSYM’s likely market future given OTC trends?

Key forward-facing market trends affecting cough OTC brands:

• Consolidation of household purchasing around fewer brands: consumers often keep a short list of trusted cough products, supporting stable baseline demand.
• Value seeking with continued preference for trusted actives: private label takes share, but national brands with differentiation and proven consumer recognition can defend against margin collapse.
• Retail media and targeted promotions: brands that sustain presence via retailer programs can reduce share loss during promo-heavy seasons.

Market dynamics snapshot

Dimension	Core driver for DELSYM	Financial implication
Seasonality	Winter respiratory demand	Strong Q4-Q1 revenue phasing
Channel	Pharmacy and mass OTC replenishment cycles	Net price depends on trade intensity
Competition	Substitution within cough symptom set	Share and margin pressure in promo peaks
Pricing	Private label and couponing	Discounting reduces net realized revenue per unit
Mix	Extended-release and format preference	Can support higher net pricing vs commodity cough SKUs

Key Takeaways

• DELSYM’s financial trajectory is driven by U.S. OTC cough seasonality with peak revenue phasing in Q4 and Q1.
• The brand’s economics hinge on net pricing resilience versus private label and multi-symptom substitution, plus mix support from extended-release formats.
• Because DELSYM-specific revenue is not separated in public financial statements, trajectory assessment relies on Reckitt brand ownership context and OTC category seasonality and promo intensity. [1]

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FAQs

1) Is DELSYM prescription or OTC?

DELSYM is sold as an OTC cough product. [1]

2) Who owns the DELSYM brand?

DELSYM is a Reckitt brand. [1]

3) When do DELSYM sales typically peak?

Sales peak during the U.S. winter respiratory season, concentrated in Q4 and Q1. (Market behavior of OTC cough products; OTC seasonality framing.) [1]

4) What hurts DELSYM profitability most?

Net pricing compression from retailer promotions, couponing, and private label substitution in peak cough months.

5) What protects DELSYM against competitive pressure?

Brand recognition in cough symptom-focused therapy and any mix advantage tied to extended-release or differentiated formats.

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References

[1] Reckitt. “Delsym.” Reckitt brand information and product page. https://www.reckitt.com/brands/delsym/