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Last Updated: April 22, 2025

PROMETHAZINE W/ DEXTROMETHORPHAN Drug Patent Profile


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When do Promethazine W/ Dextromethorphan patents expire, and when can generic versions of Promethazine W/ Dextromethorphan launch?

Promethazine W/ Dextromethorphan is a drug marketed by Xttrium Labs Inc and is included in one NDA.

The generic ingredient in PROMETHAZINE W/ DEXTROMETHORPHAN 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 W/ DEXTROMETHORPHAN
Drug patent expirations by year for PROMETHAZINE W/ DEXTROMETHORPHAN

US Patents and Regulatory Information for PROMETHAZINE W/ DEXTROMETHORPHAN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Xttrium Labs Inc PROMETHAZINE W/ DEXTROMETHORPHAN dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088864-001 Jan 4, 1985 AA RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Promethazine with Dextromethorphan

Introduction

Promethazine and Dextromethorphan is a combination drug used to treat symptoms of the common cold, allergies, and flu. This article delves into the market dynamics and financial trajectory of this drug, highlighting key factors influencing its market performance.

Market Drivers

Several factors drive the demand for Promethazine and Dextromethorphan:

Increasing Incidence of Common Cold and Flu

The rising cases of common cold and flu globally are significant drivers for this market. For instance, flu affects around 8.0% of the United States population annually, and the cumulative hospitalization rate for flu seasons indicates a consistent need for effective treatments[3].

Self-Medication Trends

There is an increasing shift towards self-medication, particularly for common cold and cough symptoms, as many cough preparations are available over-the-counter (OTC). This trend boosts the demand for combination drugs like Promethazine and Dextromethorphan[4].

Product Launches and Approvals

Recent product launches and approvals, such as the launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution by ANI Pharmaceuticals, contribute to market growth. This launch, timed just before the cough and cold season, is particularly strategic[1][2].

Market Size and Growth

The market for Dextromethorphan, a key component of this combination drug, is expected to register a Compound Annual Growth Rate (CAGR) of 4.1% over the forecast period (2024-2029). This growth is driven by increasing cases of flu and cold, as well as the launch of new dextromethorphan-based drugs[3].

Regional Performance

North America accounts for the largest market share in the Dextromethorphan market, driven by rising cases of flu, a surge in the geriatric population, and an increasing trend towards self-medication. The Asia Pacific region is expected to grow at the highest CAGR over the forecast period[3].

Financial Trajectory

The financial performance of Promethazine and Dextromethorphan is promising, given the market dynamics:

Sales Figures

The U.S. annual sales for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution total approximately $42.6 million, based on July 2024 moving annual total (MAT) IQVIA data. This figure indicates a significant market presence and potential for growth[1][2].

Company Performance

ANI Pharmaceuticals, which recently launched this oral solution, has seen strong growth in its Generics business. The company's 14th new product launch this year underscores its commitment to expanding its product portfolio and driving revenue growth[1][2].

Challenges and Restraints

Despite the positive market dynamics, there are several challenges and restraints to consider:

Side Effects and Misuse

Side effects associated with dextromethorphan drugs and the potential for misuse, particularly in codeine-containing preparations, can restrain market growth. These issues necessitate careful monitoring and regulatory oversight[3][4].

Regulatory Risks

Delays or failures in obtaining and maintaining FDA approvals, as well as changes in regulatory policies, can impact the commercial success of these products. Companies must navigate these risks to ensure continued market presence[2].

Competitive Landscape

The market for Promethazine and Dextromethorphan is competitive, with several key players:

Major Players

Companies like Astrazeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical are major players in the Dextromethorphan market. These companies engage in various growth strategies, including product launches, acquisitions, and partnerships[3].

Market Strategies

To maintain market share, companies focus on organic growth strategies such as product launches and approvals, as well as inorganic strategies like acquisitions and collaborations. For example, the launch of Chericof 12 by Sun Pharmaceutical Industries in India highlights innovative product development[3].

Consumer and Clinical Perspective

From a consumer and clinical perspective, Promethazine and Dextromethorphan offer several benefits:

Symptom Relief

This combination drug effectively reduces cough, runny or stuffy nose, and red, itchy eyes, making it a preferred treatment for common cold, allergies, and flu symptoms[5].

Convenience and Efficacy

The oral solution format, such as the one launched by ANI Pharmaceuticals, offers convenience and efficacy, especially for patients who prefer a liquid formulation.

Research and Development

Ongoing research and development in the use of dextromethorphan for other conditions also contribute to market growth:

Extended Applications

Studies like the one conducted by Stanford University on the use of dextromethorphan for symptom relief in obsessive-compulsive disorder (OCD) and related disorders indicate potential future applications beyond common cold and flu[3].

Key Takeaways

  • The market for Promethazine and Dextromethorphan is driven by increasing cases of common cold and flu, as well as trends towards self-medication.
  • North America is the largest market, with the Asia Pacific region expected to grow at the highest CAGR.
  • U.S. annual sales for the oral solution are approximately $42.6 million.
  • Companies face challenges such as side effects and regulatory risks but employ various growth strategies to maintain market share.
  • Ongoing research and development are expected to expand the applications of dextromethorphan.

FAQs

What are the primary uses of Promethazine and Dextromethorphan?

Promethazine and Dextromethorphan are used to treat symptoms of the common cold, allergies, and flu, including cough, runny or stuffy nose, and red, itchy eyes[5].

Which region has the largest market share for Dextromethorphan?

North America accounts for the largest market share in the Dextromethorphan market[3].

What is the expected CAGR for the Dextromethorphan market?

The Dextromethorphan market is expected to register a CAGR of 4.1% over the forecast period (2024-2029)[3].

What are some of the challenges facing the market for Promethazine and Dextromethorphan?

Challenges include side effects associated with dextromethorphan, potential misuse, and regulatory risks[3][4].

Which companies are major players in the Dextromethorphan market?

Major players include Astrazeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical[3].

Cited Sources

  1. ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution - ANI Pharmaceuticals, Inc.
  2. ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution - ANI Pharmaceuticals, Inc.
  3. Dextromethorphan Market Size & Share Analysis - Growth Trends - Mordor Intelligence
  4. DXM and Codeine Syrup Market Opportunities 2031 - The Insight Partners
  5. Promethazine; Dextromethorphan Oral Solution - Cleveland Clinic

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