DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for dextromethorphan hydrobromide; promethazine hydrochloride and what is the scope of patent protection?

Dextromethorphan hydrobromide; promethazine hydrochloride is the generic ingredient in five branded drugs marketed by Halsey, G And W Labs Inc, Slate Run Pharma, Amneal Pharms, Ani Pharms, Hikma, Tris Pharma Inc, and Wockhardt Bio Ag, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Twelve 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:	12
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
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	090575-001	Feb 8, 2011	AA	RX	No	No
Ani Pharms	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	011265-002	Apr 2, 1984	AA	RX	Yes	No
Halsey	PHERAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	088913-001	Mar 2, 1987		DISCN	No	No
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	091687-001	Jun 28, 2012	AA	RX	No	No
Slate Run Pharma	PROMETHAZINE DM	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040649-001	Feb 14, 2006	AA	RX	No	Yes
Hikma	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	040027-001	Jul 31, 1996		DISCN	No	No
Wockhardt Bio Ag	PROMETHAZINE W/ DEXTROMETHORPHAN	dextromethorphan hydrobromide; promethazine hydrochloride	SYRUP;ORAL	088864-001	Jan 4, 1985	AA	RX	No	No

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Introduction

Dextromethorphan hydrobromide and promethazine hydrochloride are two widely used pharmaceutical compounds, each with distinct applications and market dynamics. This article delves into the current market trends, financial trajectories, and future outlooks for these drugs.

Dextromethorphan Hydrobromide Market Dynamics

Market Size and Growth

The global dextromethorphan market was valued at USD 487.25 million in 2022 and is projected to reach USD 587.31 million by 2030, growing at a CAGR of 4.8% during the forecast period of 2023 to 2030[2].

Drivers

• Increasing Prevalence of Cough Related Conditions: The rising prevalence of respiratory conditions such as the common cold, flu, bronchitis, and allergies has significantly increased the demand for cough medications, driving the growth of the dextromethorphan market[2].
• Growing Consumer Awareness and Self Medication: Increased access to healthcare information and self-medication practices have led consumers to seek relief from cough symptoms through over-the-counter medications, contributing to market growth[2].
• Growing Investment in Healthcare Facilities: Improvements in healthcare infrastructure and investments in research and development have fostered market growth[2].

Opportunities

• Expansion of the Pharmaceutical Industry: Advancements in drug development and expanding healthcare infrastructure have positively impacted the dextromethorphan market[2].
• Technological Advancements in Drug Delivery Systems: Innovations in drug delivery systems, such as improved formulations and combination products, have enhanced the efficacy and convenience of cough medications containing dextromethorphan[2].

Restraints/Challenges

• Rising Competition: The market faces competition from local and domestic brands, as well as from other cough and cold medications[2].

Promethazine Hydrochloride Market Dynamics

Market Size and Growth

The global promethazine hydrochloride market experienced significant growth in recent years, although it was impacted by the COVID-19 pandemic. The market size reached a notable figure in 2020, with a forecasted growth rate leading to a substantial market size by 2025[1].

Drivers

• Multi-action Properties: Promethazine hydrochloride is used as an antihistamine and sedative, making it versatile in various therapeutic contexts. This multi-action property is a key driver for its market growth[5].
• Strategic Product Launches: Companies like ANI Pharmaceuticals have launched new products, such as the Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, which aligns with market opportunities and seasonal demand[4].

Opportunities

• Expanding Pharmaceutical Industry: The pharmaceutical industry's growth, driven by advancements in drug development and expanding healthcare infrastructure, benefits the promethazine hydrochloride market[3].
• Patient-Centered Care: The shift towards patient-centered care and the need for effective allergy solutions have created opportunities for promethazine hydrochloride in the market[5].

Restraints/Challenges

• COVID-19 Impact: The COVID-19 pandemic significantly affected the global economy and various industries, including the promethazine hydrochloride market, leading to a decrease in growth rates[1].
• Market Competition: The market faces competition from other antihistamines and sedatives, as well as pricing pressures and regulatory challenges[4].

Financial Trajectory

Dextromethorphan Hydrobromide

• The U.S. annual sales for dextromethorphan-containing products are substantial, with the launch of new products like the Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contributing to this revenue. For instance, the U.S. annual sales for this oral solution total approximately $42.6 million as of July 2024[4].
• The global market is expected to grow steadily, driven by increasing demand for cough medications and advancements in drug delivery systems.

Promethazine Hydrochloride

• The global market size of promethazine hydrochloride is forecasted to reach significant figures by 2025, with a CAGR that indicates steady growth despite the initial impact of the COVID-19 pandemic[1].
• Strategic product launches, such as those by ANI Pharmaceuticals, are expected to contribute to improved market share and financial performance for companies in this sector[4].

Regional Analysis

Dextromethorphan Hydrobromide

• North America: Dominates the global dextromethorphan market due to a strong base of healthcare facilities and significant research activities[2].
• Asia-Pacific: Expected to witness significant growth due to government initiatives, rising healthcare facilities, and a large population pool[2].

Promethazine Hydrochloride

• Asia Country Analysis: Countries like China, Japan, India, and Korea have been analyzed for their market size and price trends, indicating a strong presence in the Asian market[1].
• Europe: Countries such as Germany, the UK, France, and Italy also show significant market activity and growth potential[1].

Product Segmentation

Dextromethorphan Hydrobromide

• Product Type: Over-the-counter (OTC) products dominate the market due to high demand[2].
• Dosage Form: Syrup, tablet, and other forms are popular, with oral administration being the most common route[2].

Promethazine Hydrochloride

• Product Type: Different types of promethazine hydrochloride products, such as Type I and Type II, have varying market impacts and growth rates[3].
• Formulation Type: Tablet, injection, syrup, suspension, and other formulations are available, catering to different therapeutic needs[5].

Distribution Channel

Dextromethorphan Hydrobromide

• Hospital Pharmacy: A significant distribution channel, along with retail pharmacy, online pharmacy, and others[2].

Promethazine Hydrochloride

• Online and Offline Channels: Both online and offline distribution channels are crucial, with pharmaceutical wholesalers also playing a key role[5].

Key Takeaways

• The dextromethorphan hydrobromide market is driven by increasing prevalence of cough-related conditions and advancements in drug delivery systems.
• Promethazine hydrochloride's market growth is influenced by its multi-action properties and strategic product launches.
• Both markets face competition and regulatory challenges but are expected to grow steadily due to expanding healthcare infrastructure and patient-centered care approaches.
• Regional markets, especially in North America and Asia-Pacific, are significant for both drugs.

FAQs

Q: What is the projected market size for dextromethorphan hydrobromide by 2030?

A: The global dextromethorphan market is expected to reach USD 587.31 million by 2030[2].

Q: How has the COVID-19 pandemic affected the promethazine hydrochloride market?

A: The pandemic led to a decrease in the global economy and impacted the growth rate of the promethazine hydrochloride market, although it is forecasted to recover and grow by 2025[1].

Q: What are the key drivers for the dextromethorphan hydrobromide market?

A: Key drivers include the increasing prevalence of cough-related conditions, growing consumer awareness and self-medication practices, and advancements in drug delivery systems[2].

Q: Which regions are expected to dominate the promethazine hydrochloride market?

A: Asia and Europe are significant regions for the promethazine hydrochloride market, with countries like China, Japan, India, and European nations showing strong market activity[1].

Q: What is the significance of the launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution by ANI Pharmaceuticals?

A: This launch aligns with the company's strategy to expand its product portfolio and capitalize on market opportunities, particularly during the cough and cold season, and demonstrates ANI's aggressive growth strategy in the generics market[4].

Sources

1. Market Research Store: Global Promethazine Hydrochloride Market Report 2020[1].
2. Data Bridge Market Research: Global Dextromethorphan Market[2].
3. Cognitive Market Research: Global Promethazine Hydrochloride Market Report 2024 Edition[3].
4. Stock Titan: ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution[4].
5. Verified Industry Insights: Dioxy Promethazine Hydrochloride Market Analysis[5].