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Last Updated: December 22, 2024

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride and what is the scope of freedom to operate?

Codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms, Halsey, Genus, Nostrum Labs Inc, Hikma, Amneal Pharms, Cenci, and Wockhardt, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Pharmacology for CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

US Patents and Regulatory Information for CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nostrum Labs Inc PROMETH VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088764-001 Oct 31, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040674-001 Dec 23, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms PHENERGAN VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 008306-005 Apr 2, 1984 DISCN Yes 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

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride

Introduction to the Drugs

Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride are widely used pharmaceuticals with diverse applications in pain management, cough relief, and other medical conditions.

Codeine Phosphate

  • Primary Uses: Codeine Phosphate is a semi-synthetic opioid used for its analgesic, antitussive, and antidiarrheal properties. It is commonly combined with other analgesics like acetaminophen or aspirin to enhance pain relief while minimizing the risk of dependency and side effects[1][4].

Phenylephrine Hydrochloride

  • Primary Uses: Phenylephrine Hydrochloride is a decongestant used to relieve nasal congestion associated with colds, allergies, and other respiratory conditions. It is often combined with other medications like Promethazine and Codeine Phosphate to address multiple symptoms[3].

Promethazine Hydrochloride

  • Primary Uses: Promethazine Hydrochloride is an antihistamine used for treating allergy symptoms, nausea, and as a sedative. It is also used in combination with other drugs to relieve coughs and upper respiratory symptoms[3][5].

Market Size and Growth

Codeine Phosphate Market

  • The Codeine Phosphate market was valued at USD 274.39 million in 2023 and is projected to reach USD 292.64 million in 2024, expanding to USD 489.81 million by 2032, with a CAGR of 6.65% during the forecast period[1].
  • The growth is driven by the increasing prevalence of chronic pain conditions, advancements in drug formulations, and expanding healthcare infrastructure[1].

Promethazine Hydrochloride Market

  • The global Promethazine Hydrochloride market experienced significant growth, though specific recent figures are not provided. The market was impacted by the COVID-19 pandemic but is expected to recover and grow with a forecasted CAGR between 2020-2025[2][5].

Phenylephrine Hydrochloride Market

  • While specific market size data for Phenylephrine Hydrochloride is not readily available, its use in combination with other medications like Promethazine and Codeine Phosphate indicates its integral role in the broader market for respiratory and allergy treatments[3].

Drivers of Growth

Codeine Phosphate

  • Increasing Prevalence of Chronic Pain: Conditions such as osteoarthritis, rheumatoid arthritis, and cancer-related pain drive the demand for effective pain management solutions[1][4].
  • Advancements in Drug Formulations: Improved drug delivery systems and formulation technologies enhance the efficacy and safety of Codeine Phosphate[1].
  • Expanding Healthcare Infrastructure: Growing healthcare investments in developing regions increase access to advanced medical treatments and pharmaceuticals[1].

Promethazine Hydrochloride

  • Growing Awareness of Allergy and Respiratory Treatments: Increasing awareness and acceptance of antihistamine and decongestant therapies contribute to market growth[5].
  • Combination Therapies: Promethazine Hydrochloride is often used in combination with other drugs, such as Phenylephrine and Codeine Phosphate, which expands its market reach[3].

Phenylephrine Hydrochloride

  • Combination Therapies: Its use in combination with other medications like Promethazine and Codeine Phosphate for treating multiple symptoms simultaneously drives its demand[3].

Market Dynamics

Demand and Supply Factors

  • The demand for these drugs is driven by the increasing prevalence of chronic pain, allergy, and respiratory conditions. Supply is influenced by factors such as production capacity, regulatory approvals, and distribution networks[1][5].

Pricing Trends

  • Pricing is affected by competition, regulatory influences, and the cost of raw materials. Generic versions of these drugs can impact pricing by offering more affordable alternatives[1][4].

Regulatory Influences

  • Regulatory approvals and inclusion in essential medicine lists by health authorities significantly impact the availability and affordability of these drugs. For example, Akorn, Inc. received FDA approval for its Promethazine and Codeine Phosphate formulations[3].

Technological Advancements

  • Advancements in drug delivery systems and formulation technologies have enhanced the efficacy and safety profiles of these drugs, making them more appealing to both healthcare professionals and patients[1].

Regional Analysis

Codeine Phosphate

  • North America: Dominates the Codeine Phosphate market due to high healthcare expenditures and a well-developed healthcare infrastructure[4].
  • Asia-Pacific and Latin America: These regions are experiencing growth due to increasing healthcare investments and a rising middle-class population with better access to healthcare services[1].

Promethazine Hydrochloride

  • Asia-Pacific, Europe, and North America: These regions are key markets due to their large populations and advanced healthcare systems. The market in these regions is expected to grow as the global epidemic of COVID-19 is controlled and economic activities resume[2][5].

Competitive Strategies

Key Players

  • Companies like Akorn, Inc. are launching new formulations and combinations of these drugs to expand their market share. For instance, Akorn launched Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup, and Promethazine Hydrochloride, Phenylephrine Hydrochloride, and Codeine Phosphate Syrup CV[3].

Financial Trajectory

Codeine Phosphate

  • The market is expected to grow from USD 274.39 million in 2023 to USD 489.81 million by 2032, with a CAGR of 6.65% during the forecast period[1].

Promethazine Hydrochloride

  • Although specific financial projections are not detailed, the market is expected to recover and grow post-pandemic, driven by increasing demand for allergy and respiratory treatments[2][5].

Phenylephrine Hydrochloride

  • The financial trajectory is closely tied to its use in combination therapies. For example, the sales of Promethazine/Phenylephrine/Codeine Syrup were approximately $16 million for the twelve months ended July 31, 2015[3].

Challenges and Opportunities

Challenges

  • Regulatory Scrutiny: Opioid-based drugs like Codeine Phosphate face regulatory scrutiny due to their potential for abuse and dependency[1][4].
  • Competition from Generics: Generic versions of these drugs can reduce market share for branded products[1][4].

Opportunities

  • Expanding Healthcare Infrastructure: Growing healthcare investments in developing regions offer new market opportunities[1].
  • Advancements in Drug Formulations: Improvements in drug delivery systems and formulation technologies can enhance the efficacy and safety of these drugs, making them more attractive to patients and healthcare professionals[1].

Key Takeaways

  • The Codeine Phosphate market is expected to grow significantly due to the increasing prevalence of chronic pain conditions and advancements in drug formulations.
  • Promethazine Hydrochloride and Phenylephrine Hydrochloride markets are driven by the growing awareness of allergy and respiratory treatments and their use in combination therapies.
  • Regulatory approvals, technological advancements, and expanding healthcare infrastructure are key factors influencing the market dynamics of these drugs.
  • Companies are launching new formulations to capitalize on emerging opportunities and expand their market share.

FAQs

What is the projected market size for Codeine Phosphate by 2032?

The Codeine Phosphate market is projected to reach USD 489.81 million by 2032, with a CAGR of 6.65% during the forecast period[1].

How does the COVID-19 pandemic impact the Promethazine Hydrochloride market?

The COVID-19 pandemic significantly impacted the Promethazine Hydrochloride market, but it is expected to recover and grow as the global epidemic is controlled and economic activities resume[2][5].

What are the primary uses of Phenylephrine Hydrochloride?

Phenylephrine Hydrochloride is primarily used as a decongestant to relieve nasal congestion associated with colds, allergies, and other respiratory conditions[3].

Which regions dominate the Codeine Phosphate market?

North America dominates the Codeine Phosphate market, with significant growth also expected in Asia-Pacific and Latin America due to increasing healthcare investments[1][4].

What are the key drivers of the Codeine Phosphate market?

The key drivers include the increasing prevalence of chronic pain conditions, advancements in drug formulations, and expanding healthcare infrastructure[1].

Sources

  1. Global Growth Insights: Codeine Phosphate Market Share, Forecast, 2032.
  2. Market Research Store: Global Promethazine Hydrochloride Market Report 2020.
  3. BioSpace: Akorn, Inc. Launches Two Additional Promethazine Syrup Formulations.
  4. Business Research Insights: Codeine Phosphate Market Size, Share, Growth, Trends 2032.
  5. Cognitive Market Research: Global Promethazine Hydrochloride Market Report 2024 Edition.

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