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Last Updated: December 27, 2024

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for phenylephrine hydrochloride; promethazine hydrochloride and what is the scope of patent protection?

Phenylephrine hydrochloride; promethazine hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Genus, Hikma, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, and Xttrium Labs Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Pharmacology for PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

US Patents and Regulatory Information for 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
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
Genus PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040654-001 Dec 7, 2006 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040675-001 Dec 23, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms PHENERGAN VC phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 008604-003 Apr 2, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
G And W Labs Inc PROMETH VC PLAIN phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088761-001 Nov 8, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cenci PROMETHAZINE VC PLAIN phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088815-001 Nov 22, 1985 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

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Phenylephrine Hydrochloride and Promethazine Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

Phenylephrine Hydrochloride and Promethazine Hydrochloride are two significant active pharmaceutical ingredients (APIs) in the pharmaceutical industry, each with distinct applications and market dynamics. This article delves into the market size, growth drivers, challenges, and financial projections for these APIs.

Phenylephrine Hydrochloride Market Dynamics

Market Size and Growth

The Phenylephrine Hydrochloride market was valued at USD 777.6 million in 2022 and is projected to reach USD 1.6 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 7.7% during the forecast period from 2023 to 2032[1][5].

Growth Drivers

  • Demand for Decongestant Medications: The primary driver of the Phenylephrine Hydrochloride market is the consistent demand for decongestant medications, particularly for treating respiratory ailments such as the common cold, allergies, and sinus congestion[1][5].
  • Versatility in Formulations: Phenylephrine Hydrochloride is adaptable in various formulations, including nasal sprays, oral tablets, and liquids, which enhances its market appeal[1][5].
  • Impact of COVID-19: The COVID-19 pandemic indirectly boosted the demand for Phenylephrine Hydrochloride by increasing the need for cold and flu medications due to heightened concerns about respiratory symptoms[5].

Market Segmentation

  • Application: The market is segmented based on application, with nasal decongestant products being the dominant segment.
  • Mode of Manufacturing: In-house manufacturing holds a significant market share of 72.2% and is expected to grow at a CAGR of 7.6% over the forecast period[5].
  • Geographical Distribution: North America dominates the market with a 38.9% share in 2022, driven by the presence of diverse pharmaceutical manufacturers and stringent regulatory frameworks[5].

Challenges

  • Regulatory and Competitive Landscape: The market is highly competitive, with major players like Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa competing through strategic acquisitions, mergers, and partnerships[5].
  • Price Volatility: There have been instances of significant price increases for Phenylephrine Hydrochloride, particularly in the ophthalmic sector, which can impact market dynamics and consumer behavior[2].

Promethazine Hydrochloride Market Dynamics

Market Size and Growth

While specific current market size figures for Promethazine Hydrochloride are not provided in the sources, the global market is expected to grow significantly from 2024 to 2031. The report scope includes a detailed analysis of market trends, opportunities, and challenges[3].

Growth Drivers

  • Increasing Prevalence of Allergic Disorders: The demand for Promethazine Hydrochloride is driven by the rising prevalence of allergic reactions and other conditions it treats.
  • Diverse Applications: Promethazine Hydrochloride is used in various applications, including anti-allergic, anti-emetic, and sedative treatments, which broadens its market base[3].

Market Segmentation

  • Type and Application: The market is segmented by type and application, with detailed regional and country-level analyses provided[3].
  • Geographical Distribution: The market is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America, each with its own growth trends and contributing countries[3].

Challenges

  • Competition and Regulatory Compliance: The Promethazine Hydrochloride market faces competition from other antihistamines and regulatory challenges that can impact market growth.
  • ESG and PESTEL Analysis: The market is influenced by environmental, social, and governance (ESG) factors, as well as political, economic, social, technological, environmental, and legal (PESTEL) factors, which need to be carefully analyzed for strategic positioning[3].

Financial Trajectory

Phenylephrine Hydrochloride

  • Current Market Size: USD 777.6 million in 2022[1][5].
  • Projected Market Size: USD 1.6 billion by 2032[1][5].
  • CAGR: 7.7% from 2023 to 2032[1][5].

Phenylephrine Drugs Market

  • Current Market Size: USD 21.7 billion in 2023[4].
  • Projected Market Size: USD 38.4 billion by 2032[4].
  • CAGR: 6.6% from 2024 to 2032[4].

Promethazine Hydrochloride

  • While specific financial projections are not detailed, the market is expected to grow significantly from 2024 to 2031, driven by increasing demand and diverse applications[3].

Competitive Landscape

Phenylephrine Hydrochloride

The market is highly competitive with key players such as Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa. These companies engage in strategic initiatives like acquisitions, mergers, collaborations, and partnerships to maintain their market share[5].

Promethazine Hydrochloride

The competitive landscape includes various pharmaceutical companies competing in the antihistamine market. Companies are focusing on product launches, investments, and partnerships to strengthen their market position[3].

Regional Analysis

Phenylephrine Hydrochloride

North America dominates the Phenylephrine Hydrochloride market, followed by other regions. The U.S. and Germany are expected to exhibit significant growth rates during the forecast period[5].

Promethazine Hydrochloride

The market is segmented into major regions, with North America, Europe, Asia Pacific, Middle East & Africa, and Latin America each contributing to the global market growth. Regional and country-level analyses provide insights into the specific growth trends and opportunities[3].

Key Takeaways

  • Phenylephrine Hydrochloride: The market is driven by demand for decongestant medications and is expected to grow at a CAGR of 7.7% from 2023 to 2032.
  • Promethazine Hydrochloride: The market is driven by the increasing prevalence of allergic disorders and is expected to grow significantly from 2024 to 2031.
  • Competitive Landscape: Both markets are highly competitive, with key players engaging in strategic initiatives to maintain market share.
  • Regional Growth: North America is a dominant region for both markets, with other regions also showing significant growth potential.

FAQs

Q: What is the projected market size for Phenylephrine Hydrochloride by 2032?

A: The Phenylephrine Hydrochloride market is projected to reach USD 1.6 billion by 2032[1][5].

Q: What drives the demand for Phenylephrine Hydrochloride?

A: The demand is primarily driven by the consistent need for decongestant medications to treat respiratory ailments such as the common cold, allergies, and sinus congestion[1][5].

Q: How does the COVID-19 pandemic impact the Phenylephrine Hydrochloride market?

A: The pandemic indirectly boosted the demand for Phenylephrine Hydrochloride by increasing the need for cold and flu medications due to heightened concerns about respiratory symptoms[5].

Q: What is the competitive landscape like for Promethazine Hydrochloride?

A: The market is competitive, with companies focusing on product launches, investments, and partnerships to strengthen their market position[3].

Q: Which regions are expected to show significant growth in the Phenylephrine Hydrochloride market?

A: North America, particularly the U.S., and Germany are expected to exhibit significant growth rates during the forecast period[5].

Sources

  1. Global Market Insights - Phenylephrine Hydrochloride Market Size
  2. American Academy of Ophthalmology - EyeNet: Rising Prices of Phenylephrine
  3. Cognitive Market Research - Global Promethazine Hydrochloride Market Report 2024 Edition
  4. Global Market Insights - Phenylephrine Drugs Market Size & Share Report, 2024 – 2032
  5. Global Market Insights - Phenylephrine Hydrochloride Market Size Report, 2032

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