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Last Updated: December 27, 2024

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE - Generic Drug Details


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What are the generic drug sources for bromodiphenhydramine hydrochloride; codeine phosphate and what is the scope of patent protection?

Bromodiphenhydramine hydrochloride; codeine phosphate is the generic ingredient in three branded drugs marketed by Forest Labs, Alpharma Us Pharms, and Wockhardt, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
US Patents:0
Tradenames:3
Applicants:3
NDAs:3
DailyMed Link:BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE at DailyMed

US Patents and Regulatory Information for BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Us Pharms BROMANYL bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 088343-001 Aug 15, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 088626-001 Oct 12, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Forest Labs AMBENYL bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 009319-006 Jan 10, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bromodiphenhydramine Hydrochloride and Codeine Phosphate

Introduction

Understanding the market dynamics and financial trajectory of specific pharmaceuticals is crucial for stakeholders, including manufacturers, investors, and healthcare providers. This article delves into the market and financial aspects of bromodiphenhydramine hydrochloride and codeine phosphate, two drugs used in the treatment of various medical conditions.

Market Overview of Antihistamines and Narcotic Analgesics

Antihistamines

Antihistamines, such as bromodiphenhydramine hydrochloride, are widely used to treat allergic reactions. The market for antihistamines is influenced by seasonal demand, particularly during pollen blossom periods, which typically peak in the spring and summer months. This seasonal fluctuation is evident in the sales data of antihistamines, where sales volumes increase significantly during these periods[1].

Narcotic Analgesics

Codeine phosphate, a narcotic analgesic, is used to relieve pain and cough. The market for codeine phosphate is driven by the rising prevalence of cough and cold, as well as its use in various illnesses requiring pain management. The global codeine phosphate market is projected to grow at a CAGR of 4.3% from 2023 to 2032, reaching a value of USD 0.29 billion by 2032[3].

Bromodiphenhydramine Hydrochloride Market Dynamics

Uses and Mechanism of Action

Bromodiphenhydramine hydrochloride is an ethanolamine antihistamine with antimicrobial properties, used primarily in the control of cutaneous allergies. It competes with free histamine for binding at H1-receptor sites, reducing the negative symptoms brought on by histamine[5].

Market Demand

The demand for bromodiphenhydramine hydrochloride is steady, driven by its effectiveness in treating cutaneous allergies. However, the market is not as seasonal as that of other antihistamines, given its specific use case.

Pricing and Accessibility

The affordability of bromodiphenhydramine hydrochloride is a key factor in its market success. Patients often opt for drugs that are readily available and priced competitively, which can positively impact the revenue of pharmacy organizations[1].

Codeine Phosphate Market Dynamics

Uses and Mechanism of Action

Codeine phosphate is a narcotic analgesic used to relieve cough, runny or stuffy nose, sneezing, and other symptoms caused by allergies or the common cold. It acts on the central nervous system to relieve pain and is often combined with antihistamines like promethazine[4].

Market Demand

The demand for codeine phosphate is driven by its versatility in treating various symptoms. It is segmented into different applications, including narcotic analgesic, antitussive, and others. The rising prevalence of cough and cold, as well as its use in pain management, are significant drivers of this market[3].

Regulatory Considerations

Codeine phosphate is subject to strict regulatory oversight due to its potential for abuse and side effects, particularly in children. This has led to specific guidelines and restrictions on its use, especially in pediatric patients[4].

Financial Trajectory

Revenue Projections

The global codeine phosphate market is expected to grow from USD 0.20 billion in 2023 to USD 0.29 billion by 2032, at a CAGR of 4.3%. This growth is driven by increasing demand for pain management and antitussive treatments[3].

Seasonal Fluctuations

For antihistamines like bromodiphenhydramine hydrochloride, seasonal fluctuations play a significant role. Sales volumes typically peak during the spring and summer months, reflecting the increased incidence of allergic reactions during these periods[1].

Profit Margins

Pharmacy organizations benefit significantly from the sale of these drugs, especially when they are priced competitively. For instance, antihistamines priced between 100 to 500 rubles (approximately $1.38 to $6.88) contribute substantially to pharmacy profits[1].

Competitive Landscape

Key Players

The market for both bromodiphenhydramine hydrochloride and codeine phosphate is competitive, with several key players involved in their manufacture and distribution. For codeine phosphate, top companies operating in the market include those specializing in narcotic analgesics and antitussive medications[3].

Market Segmentation

The codeine phosphate market is segmented by type (extracted from opium and synthesized from morphine) and application (narcotic analgesic, antitussive, and others). This segmentation helps in targeting specific market needs and optimizing product offerings[3].

Regulatory and Safety Considerations

Safety Profile

Both bromodiphenhydramine hydrochloride and codeine phosphate have specific safety profiles that need to be considered. Codeine phosphate, in particular, has black box warnings and precautions due to its potential for respiratory depression, especially in children and ultra-rapid metabolizers[4].

Regulatory Compliance

Pharmaceutical companies must comply with stringent regulatory requirements to ensure the safe and effective use of these drugs. This includes adherence to guidelines on dosage, contraindications, and monitoring for adverse effects[4].

Consumer Preferences and Accessibility

Patient Preferences

Patients often prefer drugs that are affordable and readily available. The inclusion of these drugs in the assortment of pharmacy organizations is crucial for meeting patient preferences and ensuring quick and spontaneous purchases[1].

Distribution and Availability

Ensuring the economic and physical accessibility of these drugs is vital. Pharmaceutical organizations must maintain adequate stocks to meet seasonal and ongoing demand, ensuring that patients have access to these medications when needed[1].

Key Takeaways

  • Seasonal Demand: Antihistamines like bromodiphenhydramine hydrochloride experience peak demand during spring and summer months.
  • Market Growth: The codeine phosphate market is projected to grow at a CAGR of 4.3% from 2023 to 2032.
  • Regulatory Oversight: Codeine phosphate is subject to strict regulatory guidelines due to its potential for abuse and side effects.
  • Competitive Landscape: The market is competitive, with several key players involved in the manufacture and distribution of these drugs.
  • Safety Profile: Both drugs have specific safety profiles that need careful consideration, especially codeine phosphate’s potential for respiratory depression.

FAQs

What is the projected growth rate of the codeine phosphate market?

The codeine phosphate market is expected to exhibit a CAGR of 4.3% from 2023 to 2032[3].

What are the primary drivers of the codeine phosphate market?

The primary drivers include the rising prevalence of cough and cold, and the use of painkillers in various illnesses[3].

Why is seasonal demand important for antihistamines?

Seasonal demand is crucial because antihistamine sales volumes peak during the spring and summer months due to increased allergic reactions during these periods[1].

What are the safety concerns associated with codeine phosphate?

Codeine phosphate has safety concerns related to respiratory depression, particularly in children and ultra-rapid metabolizers. It also has black box warnings and specific precautions[4].

How does the pricing of bromodiphenhydramine hydrochloride impact its market success?

The affordability of bromodiphenhydramine hydrochloride is a key factor in its market success, as patients often opt for competitively priced drugs, which can positively impact pharmacy revenues[1].

Sources

  1. Antihistamines: research and analysis of the regional retail market.
  2. Diphenhydramine: Uses, Interactions, Mechanism of Action.
  3. Codeine Phosphate Market Size, Share, Growth, Trends 2032.
  4. Promethazine and codeine (oral route) - Mayo Clinic.
  5. Bromodiphenhydramine: Uses, Interactions, Mechanism of Action.

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