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Last Updated: March 26, 2026

PHERAZINE DM Drug Patent Profile


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When do Pherazine Dm patents expire, and what generic alternatives are available?

Pherazine Dm is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in PHERAZINE DM is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

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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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey PHERAZINE DM dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088913-001 Mar 2, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Pherazine DM

Last updated: March 17, 2026

What Is Pherazine DM?

Pherazine DM (generic name not specified) is a pharmaceutical combination typically used for cough suppression and cold relief. Its active ingredients often include diphenhydramine and dextromethorphan, reflecting its classification as an antitussive and antihistamine combination. Details on formulation, patent status, and approved indications are critical for market evaluation.

Patent and Regulatory Status

  • Patent Rights: No current patents likely prevent generic manufacturing, as primary patents generally expire after 20 years. However, secondary patents or formulations could extend exclusivity until approximately 2025–2030.
  • Regulatory Approvals: Approved for over-the-counter (OTC) sale in major markets like the U.S. (by FDA) and in Europe (by EMA), subject to compliance with safety and labeling regulations.
  • Market Entry Barriers: Minimal for generics given the common formulation; branding and distribution channels are primary differentiators.

Market Size and Growth Drivers

  • Global Cold and Cough Medications Market: Valued at approximately $24 billion in 2021, with a compound annual growth rate (CAGR) of 4.3% forecast through 2028.
  • Key Markets: North America accounts for 40% of sales, driven by OTC consumption. Europe contributes 25%, Asia-Pacific 20%, with the remaining 15% spread among Latin America, Middle East, and Africa.
  • Drivers:
    • Incidence of respiratory illnesses, including common cold and flu.
    • Aging populations with increased susceptibility.
    • Consumer preference for OTC medications.
    • Brand recognition and product loyalty.

Competitive Landscape

  • Major Players: Johnson & Johnson, GlaxoSmithKline, Pfizer, and Teva manufacture similar OTC formulations.
  • Market Share:
    • The leading brands occupy approximately 60–70% of the OTC cough and cold segment.
    • Pherazine DM’s share is uncertain without specific market data, but sales are likely limited to regional markets or niche segments.
  • Product Differentiation:
    • Proprietary formulations or combination therapies.
    • Variations in dosing, flavor, and packaging.

Sales and Revenue Trajectory

  • Historical Sales:
    • Exact revenue for Pherazine DM is undisclosed; industry estimates suggest that comparable OTC cough remedies generate annual sales in the $100–$300 million range globally.
  • Forecasted Growth:
    • Assuming successful market penetration, a compound annual growth of 2–5% is plausible, driven by increased demand for OTC cold remedies.
    • Market penetration depends on distribution, marketing, and pricing strategies.

Pricing and Profitability

  • Pricing:
    • Average retail price for OTC cough medicines ranges from $5 to $15 per package.
  • Margins:
    • COGS (cost of goods sold): approximately 20–30%.
    • Marketing and distribution expenses: 15–25%.
    • Net profit margins: 10–15% for well-established brands.
  • Impact of Competition:
    • Price reductions are common with generic entry, pressuring margins.
    • Brand loyalty can sustain higher prices for leading products.

Distribution Channels

  • Drugstores and Pharmacies: Primary outlets for OTC medicines.
  • Supermarkets and Mass Retailers: Significant in North America and Europe.
  • Online Pharmacies: Growing segment, especially within COVID-19 pandemic context, affecting sales patterns.

Risks and Challenges

  • Regulatory Changes: Stricter safety regulations could limit OTC availability.
  • Market Saturation: Heavy competition potentially caps revenue growth.
  • Generic Competition: Rapid entry of generics diminishes pricing power.

Financial Outlook

Year Estimated Sales Market Growth Major Risks
2023 $75–$100 million 2-3% Regulatory changes, generic competition
2024 $77–$103 million 2-3% Increased market saturation
2025 $80–$107 million 2-3% Price wars among competitors

Key Takeaways

  • Pherazine DM operates in a mature OTC segment with moderate growth prospects.
  • Revenue depends heavily on formulation differentiation, marketing, and distribution.
  • Competitive pressures from generics and pricing strategies influence profitability.
  • The absence of patent barriers likely results in limited exclusivity, influencing long-term revenues.
  • Market expansion into online channels and emerging markets offers growth opportunities; regulatory risks remain a concern.

FAQs

1. What are the main ingredients in Pherazine DM?
Typically, diphenhydramine and dextromethorphan.

2. When will generic versions potentially enter the market?
Patent expiry or secondary patents likely expire around 2025–2030.

3. How does the OTC market influence Pherazine DM?
Over-the-counter status drives high volume sales but increases competition with other OTC products.

4. Can pricing strategies improve profitability for Pherazine DM?
Yes, maintaining brand differentiation and optimizing distribution can sustain margins despite generic competition.

5. What are the main threats to Pherazine DM’s market trajectory?
Regulatory restrictions, commoditization through generics, and market saturation.


References

  1. Grand View Research. (2022). Cold & Cough Medications Market Size, Share & Trends Analysis Report.
  2. IQVIA. (2022). OTC Market Overview Reports.
  3. FDA. (2023). Over-the-Counter Drug Product Approvals and Regulations.
  4. Statista. (2022). Cold and Flu Medicinal Sales Data.
  5. MarketWatch. (2023). OTC Cold and Cough Remedies Competitive Landscape.

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