Dextromethorphan hydrobromide; promethazine hydrochloride - Generic Drug Details

What are the generic sources for dextromethorphan hydrobromide; promethazine hydrochloride and what is the scope of freedom to operate?

Dextromethorphan hydrobromide; promethazine hydrochloride is the generic ingredient in five branded drugs marketed by Halsey, G And W Labs Inc, Pai Holdings, Amneal Pharms, Ani Pharms, Cosette, Hikma, and Pharmobedient, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound.

Summary for dextromethorphan hydrobromide; promethazine hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	14
DailyMed Link:	dextromethorphan hydrobromide; promethazine hydrochloride at DailyMed

Pharmacology for dextromethorphan hydrobromide; promethazine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for dextromethorphan hydrobromide; promethazine hydrochloride

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

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

R06AD	Phenothiazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for dextromethorphan hydrobromide; promethazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	091687-001	Jun 28, 2012	AA	RX	No	No
G And W Labs Inc	PROMETH W/ DEXTROMETHORPHAN	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	088762-001	Oct 31, 1984		DISCN	No	No
Pai Holdings	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649-001	Feb 14, 2006	AA	RX	No	Yes
Halsey	PHERAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	088913-001	Mar 2, 1987		DISCN	No	No
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	090575-001	Feb 8, 2011	AA	RX	No	No
Pharmobedient	PROMETHAZINE W/ DEXTROMETHORPHAN	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	088864-001	Jan 4, 1985	AA	RX	No	No
Hikma	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040027-001	Jul 31, 1996		DISCN	No	No

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape for antitussives and antihistamines remains robust, influenced by evolving consumer needs, regulatory environments, and technological advancements. Among the prominent agents are dextromethorphan hydrobromide and promethazine hydrochloride, both widely utilized in cough suppressants and allergy medications. This report analyzes the current market dynamics, growth drivers, challenges, and financial trajectories for these drugs, providing crucial insights for stakeholders and investors.

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Market Overview

Dextromethorphan Hydrobromide:

Dextromethorphan (DXM) is primarily used as an antitussive in over-the-counter (OTC) cough remedies. Globally, the OTC cough and cold market exceeded USD 15 billion in 2022, with dextromethorphan constituting a significant segment due to its proven efficacy and safety profile.[1] The drug's accessibility and widespread consumer acceptance bolster steady demand, although regulatory regulation varies internationally.

Promethazine Hydrochloride:

Promethazine, an antihistamine with additional antiemetic properties, is prescribed for allergic reactions, nausea, and motion sickness. Though primarily available via prescription, a substantial OTC presence exists in specific markets. The global antihistamine market was valued at USD 5.1 billion in 2021, with promethazine accounting for a notable share, especially in North America and Europe.[2]

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Market Dynamics

Drivers

• Growing Burden of Respiratory Illnesses and Allergies:
  Increased prevalence of respiratory conditions and allergic disorders drives demand for cough suppressants and antihistamines containing dextromethorphan and promethazine. Notably, the COVID-19 pandemic accentuated the importance of effective symptomatic relief, boosting OTC utilization.

• Regulatory Environment Favoring OTC Availability:
  In regions like North America, regulatory agencies such as the FDA facilitate OTC availability of these medications, expanding consumer access and fostering market growth.

• Advancements in Formulation Technologies:
  Innovations enhancing drug delivery, bioavailability, and patient compliance—such as sustained-release formulations—have strengthened market appeal.

• Broad-Consumer Base:
  Children, adults, and elderly populations use these drugs, increasing market penetration.

Challenges

• Regulatory Restrictions and Abuse Potential:
  Dextromethorphan faces scrutiny due to abuse potential leading to recreational misuse. Some jurisdictions have implemented sales restrictions or age limits, which can variably impact market availability [3].

• Safety Concerns and Side Effects:
  Promethazine's sedative effects, risk of respiratory depression in certain populations, and potential drug interactions necessitate cautious prescribing, possibly impacting demand growth.

• Market Saturation and Competitive Landscape:
  A multitude of generic products exists, squeezing profit margins and incentivizing innovation or differentiation.

• COVID-19 Disruption:
  While initially boosting sales, pandemic-related supply chain disruptions and shifting healthcare priorities pose risks.

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Financial Trajectory Analysis

Market Revenues and Growth Patterns

• Dextromethorphan Hydrobromide:
  The OTC cough formulation segment grew at a compound annual growth rate (CAGR) of approximately 4.2% between 2017 and 2022. Driven by increased consumption and expanding markets in Asia-Pacific, notably China and India, revenue forecasts project reaching USD 7.8 billion by 2026.[4]

• Promethazine Hydrochloride:
  Despite being prescription-based, the antihistamine segment exhibits a CAGR of 3.5% from 2021 to 2026, supported by expanding allergy diagnoses and aging populations. Global revenues are expected to approach USD 6 billion by 2025.[5]

Market Share and Competitive Dynamics

Major pharmaceutical firms like Johnson & Johnson, GlaxoSmithKline, and Teva Pharmaceuticals dominate the dextromethorphan segment, leveraging extensive distribution channels and brand recognition. In contrast, generic producers chiefly supply promethazine, intensifying price competition.

R&D and Pipeline Activity

While research on new formulations or combination therapies remains modest for these drugs, ongoing post-marketing surveillance ensures safety updates and potential labeling modifications, impacting sales consistency.

Pricing Trends

Price erosion due to generics, combined with strict regulatory controls, constrains profit margins. Strategic partnerships and formulation innovation remain pivotal for financial sustainability.

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Regional Market Insights

• North America:
  Favorable regulatory climate and high consumer health awareness generate stable demand. However, regulatory scrutiny influences product labeling and permissible formulations.

• Europe:
  Stringent safety regulations restrict certain indications, but mature distribution channels ensure consistent sales.

• Asia-Pacific:
  Rapid population growth, increased healthcare expenditure, and expanding OTC drug markets present significant growth opportunities, with CAGR projections exceeding 5%.

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Regulatory and Policy Impact

The evolving regulatory landscape, especially concerns over drug misuse and safety, necessitates ongoing compliance efforts. Governments' initiatives to curb abuse—such as age restrictions and sales limits—may temporarily hinder market expansion but are essential for long-term sustainability.

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Future Outlook and Strategic Implications

• Emerging markets will be central to expansion, driven by rising disposable incomes and healthcare access.

• Innovation in drug delivery systems—including nasal sprays, dissolving tablets, and sustained-release formulations—will differentiate products and support premium pricing.

• Regulatory adaptation and compliance will mitigate risks associated with misuse and safety concerns, sustaining market viability.

• Partnerships and licensing agreements will drive expansion and diversification, particularly in regions with emerging healthcare infrastructures.

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Key Takeaways

• The market for dextromethorphan hydrobromide and promethazine hydrochloride remains steady, bolstered by consistent demand for cough and allergy relief medications.

• Regulatory pressures, especially regarding misuse potential, will influence future sales strategies and formulations.

• Asia-Pacific and emerging markets offer high-growth prospects, contingent on regulatory and cultural acceptance.

• Innovation in drug formulations and delivery methods will underpin competitive advantages.

• Price competition driven by generics necessitates strategic differentiation, including branding and patent management.

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FAQs

1. What are the primary factors influencing the demand for dextromethorphan hydrobromide?
Demand is driven by the prevalence of respiratory illnesses, consumer preference for OTC medications, and regulatory policies facilitating OTC access. The COVID-19 pandemic temporarily increased demand for symptomatic relief.

2. How are regulatory restrictions affecting the market for promethazine hydrochloride?
Regulations prioritize safety, leading to restrictions on certain formulations, age limits, and usage warnings. These measures can reduce accessibility but promote safer prescribing practices.

3. What is the outlook for innovation within these drug markets?
Focus areas include developing sustained-release formulations, combination therapies, and alternative delivery systems to improve efficacy, compliance, and differentiation.

4. How does the geographic distribution impact market growth?
Emerging markets in Asia-Pacific and Latin America show higher growth potential due to demographic trends and increasing healthcare infrastructure, whereas mature markets like North America and Europe exhibit steady, mature growth.

5. What are the main risks for investors in these drug segments?
Regulatory changes, misuse controversies, price erosion due to generics, and shifting healthcare policies pose risks. Strategic planning and diversification are essential for mitigating these threats.

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References

[1] MarketWatch. “OTC Cough & Cold Market Size & Trends.” 2022.
[2] Research and Markets. “Antihistamines Market Analysis.” 2021.
[3] U.S. FDA. “Regulation of Dextromethorphan Sales.” 2020.
[4] Grand View Research. “Dextromethorphan Market Forecasts.” 2022.
[5] MarketsandMarkets. “Antihistamines Market Trends & Projections.” 2021.