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Last Updated: December 22, 2024

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE Drug Patent Profile


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When do Promethazine Hydrochloride And Phenylephrine Hydrochloride patents expire, and what generic alternatives are available?

Promethazine Hydrochloride And Phenylephrine Hydrochloride is a drug marketed by Amneal Pharms and is included in one NDA.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.

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Summary for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Drug patent expirations by year for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
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US Patents and Regulatory Information for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040902-001 Aug 25, 2009 AA RX 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

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Promethazine Hydrochloride and Phenylephrine Hydrochloride

Introduction

Promethazine hydrochloride and phenylephrine hydrochloride are key components in various pharmaceutical formulations, particularly those aimed at relieving upper respiratory symptoms associated with allergies and the common cold. This article delves into the market dynamics and financial trajectory of these drugs, highlighting their current status, growth drivers, and future projections.

Market Size and Growth Projections

The market for phenylephrine hydrochloride, a crucial ingredient in these formulations, is substantial and growing. As of 2022, the phenylephrine hydrochloride market was valued at USD 777.6 million and is anticipated to reach USD 1.6 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 7.7% during the forecast period[1].

For the broader phenylephrine drugs market, which includes various formulations containing phenylephrine, the market size was valued at USD 21.7 billion in 2023 and is expected to grow at a CAGR of 6.6% between 2024 and 2032, reaching USD 38.4 billion by 2032[3].

Key Applications and Indications

Promethazine hydrochloride and phenylephrine hydrochloride are primarily used for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergies or the common cold. Here are some key applications:

  • Nasal Decongestion: Phenylephrine hydrochloride is a vital component in nasal decongestant medications, providing relief from nasal congestion by constricting blood vessels in the nasal passages[1][2].
  • Cold and Allergic Reactions: These drugs are indicated for the relief of symptoms associated with colds and allergic reactions, such as sneezing, runny nose, and itchy eyes[2][3].
  • Other Indications: They are also used in the treatment of eye diseases and hypotension, among other applications[1][3].

Route of Administration

The phenylephrine drugs market is segmented by route of administration, with the oral segment dominating the market. In 2023, the oral segment held a market share of 52.5%[3].

  • Oral Formulations: Promethazine and phenylephrine are available in oral solutions, tablets, and syrups. These formulations are widely used due to their ease of administration and effectiveness[2][4].
  • Topical and Parenteral Routes: While less common, these drugs can also be administered topically or parenterally, depending on the specific indication and formulation[2].

Geographical Distribution

The market for these drugs is geographically diverse, with North America holding a significant share.

  • North America: This region dominated the phenylephrine hydrochloride market with a business share of 38.9% in 2022 and is expected to continue its dominance throughout the forecast period. The U.S. market, in particular, is expected to exhibit a CAGR of 6.9% between 2024 and 2032[1][3].
  • Europe and Asia: Countries like Germany and India are also expected to show significant growth in the phenylephrine drugs market during the forecast period[3].

Competitive Landscape

The market for promethazine hydrochloride and phenylephrine hydrochloride is highly competitive, with several major players.

  • Key Players: Companies such as Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa hold significant market shares. Other players like Akorn, Inc. are also active in the market, launching new formulations and expanding their product portfolios[1][4].
  • Strategic Initiatives: These companies engage in strategic acquisitions, mergers, collaborations, and partnerships to maintain a competitive edge and address the rising demand for phenylephrine-based drugs[1][3].

Growth Drivers

Several factors drive the growth of the market for these drugs:

  • Increasing Prevalence of Respiratory Diseases: The rise in respiratory diseases such as the common cold, allergies, and sinusitis increases the demand for phenylephrine-based drugs. For instance, around 28.9 million adults in the U.S. were diagnosed with sinusitis in 2022[3].
  • Preference for Non-Sedating Decongestants: Phenylephrine is favored over pseudoephedrine due to its non-sedating properties, which aligns with consumer preferences for medications that do not cause drowsiness[3].

Challenges and Pitfalls

Despite the growth potential, the market faces several challenges:

  • Regulatory Frameworks: The manufacturing and distribution of these drugs are subject to stringent regulatory standards, which can be a challenge for new entrants and existing players alike[1].
  • COVID-19 Pandemic Impact: The COVID-19 pandemic had indirect effects on the phenylephrine hydrochloride market, including disruptions in the pharmaceutical industry and shifts in consumer behavior[1].

Pharmacology and Clinical Use

Understanding the pharmacology of these drugs is crucial for their effective use.

  • Promethazine Hydrochloride: Promethazine is an H1 receptor blocking agent with antihistaminic, sedative, and antiemetic effects. It is well absorbed from the gastrointestinal tract and has a half-life of approximately 12-15 hours[2][5].
  • Phenylephrine Hydrochloride: Phenylephrine causes vasoconstriction, increasing resistance and decreasing capacitance of blood vessels. It is irregularly absorbed from the gastrointestinal tract and is metabolized in the liver and intestine[2].

Safety and Adverse Effects

Both drugs have potential adverse effects that need to be considered:

  • Promethazine: Adverse effects include respiratory depression, neuroleptic malignant syndrome, and paradoxical reactions such as hyperexcitability and abnormal movements[2][5].
  • Phenylephrine: Adverse effects include hypertension, nervous system reactions like restlessness and anxiety, and cardiovascular effects such as bradycardia and increased cardiac workload[2].

Key Takeaways

  • The market for promethazine hydrochloride and phenylephrine hydrochloride is growing, driven by the increasing prevalence of respiratory diseases and consumer preference for non-sedating decongestants.
  • North America dominates the market, with significant growth expected in other regions like Europe and Asia.
  • The competitive landscape is characterized by strategic initiatives among major players to maintain market share.
  • Understanding the pharmacology and potential adverse effects of these drugs is crucial for their safe and effective use.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for promethazine hydrochloride and phenylephrine hydrochloride? A: These drugs are primarily indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergies or the common cold.

Q: Which region dominates the phenylephrine hydrochloride market? A: North America dominates the phenylephrine hydrochloride market, with a significant business share.

Q: What is the expected growth rate of the phenylephrine drugs market between 2024 and 2032? A: The phenylephrine drugs market is expected to grow at a CAGR of 6.6% between 2024 and 2032.

Q: What are the main growth drivers for the phenylephrine hydrochloride market? A: The main growth drivers include the increasing prevalence of respiratory diseases and consumer preference for non-sedating decongestants.

Q: Which companies are key players in the phenylephrine hydrochloride market? A: Key players include Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa, among others.

Cited Sources:

  1. Global Market Insights, "Phenylephrine Hydrochloride Market Size Report, 2032"
  2. Drugs.com, "Promethazine and Phenylephrine: Package Insert / Prescribing Info"
  3. Global Market Insights, "Phenylephrine Drugs Market Size & Share Report, 2024 – 2032"
  4. Biospace, "Akorn, Inc. Launches Two Additional Promethazine Syrup Formulations"
  5. DrugBank, "Promethazine: Uses, Interactions, Mechanism of Action"

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