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Last Updated: December 22, 2024

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Drug Patent Profile


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

Phenylephrine Hydrochloride And Promethazine Hydrochloride is a drug marketed by Genus and Hikma and is included in two NDAs.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE 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 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
Drug patent expirations by year for PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
Pharmacology for PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

US Patents and Regulatory Information for PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phenylephrine Hydrochloride and Promethazine Hydrochloride

Overview of Phenylephrine Hydrochloride and Promethazine Hydrochloride

Phenylephrine hydrochloride and promethazine hydrochloride are two significant active pharmaceutical ingredients (APIs) used in various medical applications. Here, we will delve into the market dynamics, financial trajectories, and key factors influencing these markets.

Phenylephrine Hydrochloride Market

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 CAGR of 7.7% during the forecast period[1].

Key Applications

Phenylephrine hydrochloride is primarily used in nasal decongestant medications, treating conditions such as the common cold, allergies, and sinusitis. Its application in cold and flu medications saw an increase during the COVID-19 pandemic due to heightened concerns about respiratory symptoms[1].

Regional Dominance

North America dominates the phenylephrine hydrochloride market, holding a 38.9% market share in 2022. This region is home to a diverse array of pharmaceutical manufacturers, ensuring stringent quality and safety standards overseen by regulatory bodies like the FDA and Health Canada[1].

Competitive Landscape

The market is highly competitive, with key players like Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa holding significant market shares. These companies engage in strategic acquisitions, mergers, collaborations, and partnerships to maintain their competitive edge[1].

Promethazine Hydrochloride Market

Market Size and Growth

The promethazine hydrochloride injection market has witnessed substantial growth and is expected to continue this trend from 2023 to 2031. The market is categorized by type (intravenous drip, intramuscular injection) and application (hospital, clinics, other)[3].

Key Applications

Promethazine hydrochloride is used to relieve cough and upper respiratory symptoms, as well as nasal congestion. It is often combined with other ingredients like phenylephrine and codeine in cough syrups[2].

Regional Outlook

The market is segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The positive outlook suggests strong growth rates in these regions, driven by increasing demand for promethazine hydrochloride injections in healthcare settings[3].

Competitive Dynamics

Similar to the phenylephrine hydrochloride market, the promethazine hydrochloride market is characterized by the presence of established pharmaceutical companies. These companies are involved in strategic initiatives such as collaborations, product launches, and partnerships to strengthen their market positions[3].

Drivers and Challenges

Drivers

  • Increasing Prevalence of Respiratory Diseases: The rise in conditions like the common cold, allergies, and sinusitis drives the demand for both phenylephrine and promethazine hydrochloride-based drugs[4].
  • COVID-19 Pandemic: The pandemic led to increased demand for medications alleviating respiratory symptoms, indirectly boosting the market for these APIs[1].

Challenges

  • Regulatory Frameworks: Stringent quality and safety standards set by regulatory bodies like the FDA and Health Canada can pose challenges for manufacturers[1].
  • Market Competition: The highly competitive nature of the market requires companies to continuously innovate and engage in strategic initiatives to maintain market share[1][3].

Financial Trajectory

Phenylephrine Hydrochloride

  • The market is expected to grow from USD 777.6 million in 2022 to USD 1.6 billion by 2032, with a CAGR of 7.7%[1].
  • The oral segment of phenylephrine drugs, which includes decongestants, dominated the market with a 52.5% market share in 2023 and is expected to continue growing[4].

Promethazine Hydrochloride

  • The promethazine hydrochloride injection market is projected to experience sustained and significant expansion from 2023 to 2031, driven by increasing demand in healthcare settings[3].

Regional Insights

North America

  • North America is a dominant region for both phenylephrine and promethazine hydrochloride markets, with significant market shares in 2022 and 2023, respectively[1][4].

Europe and Asia-Pacific

  • Countries like Germany in Europe and India in Asia-Pacific are expected to exhibit high growth rates in the phenylephrine drugs market during the forecast period[4].
  • The Asia-Pacific region is also anticipated to contribute significantly to the growth of the promethazine hydrochloride injection market[3].

Key Players and Strategies

Phenylephrine Hydrochloride

  • Key players such as Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa are engaged in strategic acquisitions, mergers, collaborations, and partnerships to maintain their competitive edge[1].

Promethazine Hydrochloride

  • Established pharmaceutical companies are actively adopting multi-pronged approaches, including collaborations, product launches, and partnerships to address the rising demand for promethazine hydrochloride injections[3].

Conclusion

The markets for phenylephrine hydrochloride and promethazine hydrochloride are poised for significant growth driven by increasing demand for treatments of respiratory diseases and the aftermath of the COVID-19 pandemic. Understanding the market dynamics, regional insights, and strategies of key players is crucial for businesses looking to capitalize on these trends.

Key Takeaways

  • Growing Demand: Increasing prevalence of respiratory diseases drives the demand for both APIs.
  • Regional Dominance: North America is a key region for both markets.
  • Competitive Landscape: The markets are highly competitive, with key players engaging in strategic initiatives.
  • Regulatory Compliance: Manufacturers must adhere to stringent quality and safety standards.
  • Market Growth: Both markets are expected to see substantial growth over the forecast periods.

FAQs

What is the projected market size for phenylephrine hydrochloride by 2032?

The phenylephrine hydrochloride market is anticipated to reach USD 1.6 billion by 2032[1].

What are the primary applications of phenylephrine hydrochloride?

Phenylephrine hydrochloride is primarily used in nasal decongestant medications and treatments for cold, allergies, and sinusitis[1].

How has the COVID-19 pandemic affected the market for these APIs?

The pandemic led to increased demand for medications alleviating respiratory symptoms, indirectly boosting the market for both phenylephrine and promethazine hydrochloride[1].

Which region dominates the phenylephrine hydrochloride market?

North America dominates the phenylephrine hydrochloride market, holding a 38.9% market share in 2022[1].

What is the expected growth rate for the promethazine hydrochloride injection market?

The promethazine hydrochloride injection market is expected to experience sustained and significant expansion from 2023 to 2031, though specific growth rates are not provided in the sources[3].

Sources

  1. GMI Insights: Phenylephrine Hydrochloride Market Size Report, 2032
  2. DrugBank: Promethazine: Uses, Interactions, Mechanism of Action
  3. Market Research Intellect: Global Promethazine Hydrochloride Injection Market Size, Trends
  4. GMI Insights: Phenylephrine Drugs Market Size & Share Report, 2024 – 2032
  5. Business Wire: Global Phenylephrine Hydrochloride Market Insights (2021 to 2026)

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