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Last Updated: December 22, 2024

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Drug Patent Profile


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When do Promethazine Hydrochloride And Dextromethorphan Hydrobromide patents expire, and what generic alternatives are available?

Promethazine Hydrochloride And Dextromethorphan Hydrobromide is a drug marketed by Amneal Pharms, Ani Pharms, Hikma, and Tris Pharma Inc. and is included in four NDAs.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

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Summary for PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
US Patents:0
Applicants:4
NDAs:4
Finished Product Suppliers / Packagers: 5
What excipients (inactive ingredients) are in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE?PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE excipients list
DailyMed Link:PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE at DailyMed
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Pharmacology for PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

US Patents and Regulatory Information for PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Introduction

Promethazine hydrochloride and dextromethorphan hydrobromide is a combination drug commonly used for the temporary relief of coughs and upper respiratory symptoms associated with allergies or the common cold. This article delves into the market dynamics and financial trajectory of this drug, highlighting key drivers, opportunities, and challenges.

Market Size and Growth

The global dextromethorphan market, which includes products like promethazine hydrochloride and dextromethorphan hydrobromide, was valued at USD 487.25 million in 2022. It is projected 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].

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 significantly drives the demand for cough medications. Dextromethorphan, as an antitussive agent, is a key component in many over-the-counter (OTC) cough suppressants, contributing to market growth[1].

Growing Consumer Awareness and Self-Medication

Increased access to healthcare information and the practice of self-medication have made consumers more aware of OTC medications like dextromethorphan. This awareness leads to higher sales of products containing dextromethorphan, further boosting the market[1].

Growing Investment in Healthcare Facilities

The surging focus on improving healthcare facilities and infrastructure, along with rising partnerships and strategic collaborations between public and private players, creates lucrative opportunities for the market. This investment in healthcare enhances the availability and accessibility of medications like promethazine hydrochloride and dextromethorphan hydrobromide[1].

Opportunities in the Market

Expansion of the Pharmaceutical Industry

The pharmaceutical industry is experiencing growth due to advancements in drug development, increasing investments in research and development, and expanding healthcare infrastructure. This growth directly benefits the market for dextromethorphan-containing products[1].

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. These advancements attract consumers and contribute to market expansion[1].

Restraints and Challenges

Rising Competition

The market faces significant competition from both local and global brands. This competition can lead to pricing pressures and challenges in capturing market share, especially for new entrants or smaller players[1].

Regulatory and Safety Concerns

Promethazine hydrochloride and dextromethorphan hydrobromide have specific contraindications, such as use in children under 2 years of age and in patients receiving monoamine oxidase inhibitors (MAOIs). These regulatory and safety concerns can impact market growth and require careful management by manufacturers[2][5].

Regional Market Dynamics

North America

North America dominates the global dextromethorphan market due to a strong base of healthcare facilities, a strong presence of major players, and rising research activities in the region[1].

Asia-Pacific

The Asia-Pacific region is expected to witness significant growth during the forecast period due to government initiatives, increasing healthcare facilities, growing research activities, and a large population pool. This region presents substantial opportunities for market expansion[1].

Recent Market Developments

ANI Pharmaceuticals Launch

ANI Pharmaceuticals recently launched Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, marking their 14th new product launch in 2024. This strategic move aligns with the upcoming cough and cold season and is expected to contribute to the company's strong growth in the generics market[3][4].

Financial Trajectory

U.S. Annual Sales

The U.S. annual sales for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution total approximately $42.6 million, based on July 2024 data from IQVIA. This figure indicates a significant market presence and potential for further growth[3][4].

Strategic Impact

The consistent pipeline execution by ANI Pharmaceuticals, including this recent launch, could lead to improved market share and financial performance. However, investors must consider factors such as market competition and pricing pressures to fully assess the financial impact[4].

Key Takeaways

  • The global dextromethorphan market is expected to grow at a CAGR of 4.8% from 2023 to 2030.
  • Increasing prevalence of cough-related conditions and growing consumer awareness drive market growth.
  • Technological advancements in drug delivery systems and expansion of the pharmaceutical industry present opportunities.
  • Regulatory and safety concerns, along with rising competition, are key challenges.
  • North America and Asia-Pacific are significant regions for market growth.
  • Recent launches by companies like ANI Pharmaceuticals are strategic moves to capitalize on market opportunities.

FAQs

What is the projected market size for the global dextromethorphan market by 2030?

The global dextromethorphan market is projected to reach USD 587.31 million by 2030[1].

What are the main drivers of the market growth for promethazine hydrochloride and dextromethorphan hydrobromide?

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

Which regions are expected to see significant growth in the dextromethorphan market?

North America and the Asia-Pacific region are expected to see significant growth during the forecast period[1].

What is the U.S. annual sales figure for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution?

The U.S. annual sales for this oral solution total approximately $42.6 million, based on July 2024 data from IQVIA[3][4].

What are the contraindications for promethazine hydrochloride and dextromethorphan hydrobromide?

The drug is contraindicated for children under 2 years of age and in patients receiving monoamine oxidase inhibitors (MAOIs)[2][5].

Sources

  1. Data Bridge Market Research, Global Dextromethorphan Market – Industry Trends and Forecast to 2030.
  2. DailyMed, Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.
  3. ANI Pharmaceuticals, ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.
  4. Stock Titan, ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.
  5. Drugs.com, Promethazine DM Dosage Guide.

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