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Last Updated: March 22, 2025

PHERAZINE DM Drug Patent Profile


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Summary for PHERAZINE DM
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PHERAZINE DM at DailyMed
Drug patent expirations by year for PHERAZINE DM

US Patents and Regulatory Information for PHERAZINE DM

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Halsey PHERAZINE DM dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088913-001 Mar 2, 1987 DISCN 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

Understanding the Market Dynamics and Financial Trajectory of Promethazine DM

Introduction

Promethazine DM, a medication combining promethazine and dextromethorphan, is primarily used to treat coughs and colds. However, its use and abuse have significant implications for both public health and the pharmaceutical industry. Here, we will delve into the market dynamics and financial trajectory associated with Promethazine DM.

What is Promethazine DM?

Promethazine DM is a generic medication that includes promethazine, an antihistamine, and dextromethorphan, a cough suppressant. It is used to alleviate symptoms of allergies, the common cold, and motion sickness, but it has also been misused for its sedative effects[4].

Market Dynamics

Prescription and Over-the-Counter Sales

Promethazine DM is available by prescription and, in some cases, over-the-counter. The market for such medications is influenced by seasonal demand, with higher sales during cold and flu seasons. However, the misuse of these drugs, particularly when combined with codeine, has led to increased regulatory scrutiny and public health concerns[4].

Competitive Landscape

The pharmaceutical market for antihistamines and cough suppressants is highly competitive. The development of "me-too" or follow-on drugs, which offer similar therapeutic benefits, can impact the market share of existing drugs. Studies have shown that the period of marketing exclusivity for breakthrough drugs has decreased over time, leading to quicker entry of competitive products into the market[3].

Regulatory Environment

Regulatory bodies have been vigilant about the misuse of promethazine and codeine combinations. Stricter regulations and monitoring have been implemented to curb the abuse of these substances. This regulatory environment can affect the sales and profitability of Promethazine DM[4].

Financial Trajectory

Revenue and Sales

The revenue generated from Promethazine DM is influenced by its prescription and over-the-counter sales. However, the financial performance of companies producing this medication can be volatile due to factors such as regulatory changes, competition, and public health concerns. For instance, MEI Pharma reported a revenue increase from $40.7 million to $48.8 million between 2022 and 2023, but this was largely due to the recognition of previously deferred revenue rather than increased sales of specific products like Promethazine DM[2].

Research and Development Expenses

Companies involved in the production of Promethazine DM and similar medications often incur significant research and development expenses. These costs are crucial for maintaining market competitiveness and addressing emerging health issues. For example, Prime Medicine reported an increase in R&D expenses from $30.9 million to $37.8 million between the first quarters of 2023 and 2024, reflecting the ongoing investment in their pipeline and platform[5].

General and Administrative Expenses

General and administrative expenses also play a significant role in the financial trajectory of companies producing Promethazine DM. These expenses can include costs related to marketing, regulatory compliance, and workforce management. MEI Pharma, for instance, saw an increase in G&A expenses from $30.5 million to $33.1 million between 2022 and 2023, partly due to severance costs and higher external professional services[2].

Abuse and Misuse Impact

Public Health Concerns

The misuse of Promethazine DM, particularly when combined with codeine, has severe public health implications. This includes risks such as respiratory depression, seizures, and fatal overdoses. These concerns can lead to decreased sales and increased regulatory scrutiny, affecting the financial performance of companies involved[4].

Economic Burden

The economic burden of substance abuse, including the misuse of Promethazine DM, is substantial. It includes costs related to healthcare, law enforcement, and lost productivity. Addressing these issues requires significant investment in public health programs and addiction treatment services, which can indirectly impact the financial trajectory of pharmaceutical companies[4].

Financial Performance Indicators

Cash Flow and Liquidity

Companies producing Promethazine DM need to maintain a strong cash position to fund operations, research, and development. MEI Pharma, for example, had $100.7 million in cash, cash equivalents, and short-term investments as of June 30, 2023, which is sufficient to fund operations for at least the next 12 months[2].

Net Loss and Profitability

The net loss of companies involved in the production of Promethazine DM can be significant due to high operating expenses and regulatory challenges. Prime Medicine reported a net loss of $45.8 million for the first quarter of 2024, compared to $39.4 million for the same period in 2023[5].

Key Takeaways

  • Market Dynamics: The market for Promethazine DM is influenced by seasonal demand, regulatory environment, and competitive landscape.
  • Financial Trajectory: Revenue and sales are impacted by regulatory changes, competition, and public health concerns. Research and development expenses, as well as general and administrative costs, are significant.
  • Abuse and Misuse: The misuse of Promethazine DM has severe public health implications and economic burdens.
  • Financial Performance: Companies need to maintain a strong cash position and manage high operating expenses to remain profitable.

FAQs

What is Promethazine DM used for?

Promethazine DM is used to treat coughs and colds, combining the antihistamine promethazine with the cough suppressant dextromethorphan.

Why is Promethazine DM abused?

Promethazine DM is abused for its sedative effects, particularly when combined with codeine to create substances like "purple drank" or "lean."

What are the risks associated with Promethazine DM abuse?

Abuse of Promethazine DM can lead to respiratory depression, seizures, fatal overdoses, and long-term health issues such as memory loss and cardiovascular problems.

How does regulatory scrutiny impact the financial trajectory of Promethazine DM?

Regulatory scrutiny can lead to decreased sales, increased costs for compliance, and potential legal liabilities, all of which can negatively impact the financial performance of companies producing Promethazine DM.

What are the economic implications of Promethazine DM abuse?

The economic implications include healthcare costs, law enforcement expenses, and lost productivity, all of which contribute to a significant economic burden.

Sources

  1. Promethazine Addiction: Understanding Promethazine Abuse - The Hope House
  2. MEI Pharma Reports Fiscal Year 2023 Results and Operational Updates - MEI Pharma
  3. The economics of follow-on drug research and development - PubMed
  4. Promethazine Abuse: The Dangers of Codeine Addiction - Gratitude Lodge
  5. Prime Medicine Reports First Quarter 2024 Financial Results and Operational Updates - Prime Medicine

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