You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Diphenhydramine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for diphenhydramine hydrochloride; pseudoephedrine hydrochloride and what is the scope of patent protection?

Diphenhydramine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in one branded drug marketed by Parke Davis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for diphenhydramine hydrochloride; pseudoephedrine hydrochloride
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 3
DailyMed Link:diphenhydramine hydrochloride; pseudoephedrine hydrochloride at DailyMed
Recent Clinical Trials for diphenhydramine hydrochloride; pseudoephedrine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ache Laboratorios Farmaceuticos S.A.Phase 3
Johnson & Johnson Consumer and Personal Products WorldwidePhase 4

See all diphenhydramine hydrochloride; pseudoephedrine hydrochloride clinical trials

US Patents and Regulatory Information for diphenhydramine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis BENYLIN diphenhydramine hydrochloride; pseudoephedrine hydrochloride SOLUTION;ORAL 019014-001 Jun 11, 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

Diphenhydramine hydrochloride; pseudoephedrine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Diphenhydramine Hydrochloride

Market Overview

The diphenhydramine hydrochloride market is poised for steady growth, driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The diphenhydramine market is estimated to reach USD 0.99 billion in 2024 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.30% to reach USD 1.10 billion by 2029[1][3].

Key Drivers of Growth

Increasing Prevalence of Allergies

The rising number of people suffering from seasonal allergies and allergic rhinitis is a significant driver. According to the Centers for Disease Control and Prevention, approximately 25.7% of US adults reported experiencing seasonal allergies in 2022, which is expected to increase the demand for effective medications like diphenhydramine[1][3].

Growing Incidence of Motion Sickness and Insomnia

Motion sickness among international travelers and the increasing prevalence of insomnia are also driving the market. For instance, an estimated 66.5 million tourists traveled internationally in the United States in 2023, increasing the risk of motion sickness and thus the demand for diphenhydramine[1].

Rising Prevalence of Cold and Flu Cases

The growing number of cold and flu cases globally also contributes to the market's expansion. About 35 to 64 million flu cases were reported in the United States from October 2024 to June 2024, increasing the demand for medications that relieve symptoms such as runny nose, sneezing, and watery eyes[1][3].

Regional Market Analysis

North America

North America is anticipated to hold the largest market share due to the high burden of allergies and insomnia in the region. The increasing number of international travelers experiencing motion sickness also contributes to this dominance[1][3].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market, driven by increasing research and development activities and a growing population with allergic conditions[1][3].

Market Concentration and Major Players

The diphenhydramine market has a medium level of concentration, with key players such as Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd. These companies are involved in strategic collaborations and product innovations to maintain their market position[1][3].

Side Effects and Challenges

Despite the growth drivers, the side effects of diphenhydramine, such as anticholinergic toxicity, respiratory failure, arrhythmias, and cardiac arrest, are likely to hinder the market's growth. Proper patient education and adherence to dosage instructions are crucial to mitigate these risks[2].

Availability and Accessibility

Diphenhydramine's availability as an over-the-counter (OTC) medication enhances its accessibility, making it a preferred choice for consumers without the need for a prescription. This accessibility is a significant factor in boosting sales and market growth[1][3].

Research and Development

Increasing research and development expenditures aimed at exploring new applications and formulations of diphenhydramine are expected to further boost the market. This includes innovations in delivery methods and the development of new products targeting specific conditions like insomnia and motion sickness[1][3].

Market Volume and CAGR

In terms of volume, the global diphenhydramine hydrochloride market was roughly 61 thousand tonnes in 2023 and is anticipated to grow at a CAGR of 3.5% until 2034[4].

Consumer Health Trends

The broader consumer healthcare market, within which diphenhydramine operates, is also experiencing significant growth. The global consumer healthcare market was valued at $281 billion in 2022 and is poised to grow to $543.27 billion by 2031, with a CAGR of 7.60% during the forecast period (2024-2031)[5].

Online Distribution and E-commerce

The online distribution channel is set to become the fastest-growing segment in the global consumer healthcare market, fueled by the increasing penetration of the internet and the rising popularity of e-commerce. This trend is expected to benefit the diphenhydramine market as well, making the product more accessible to a wider audience[5].

Key Takeaways

  • Market Size: Expected to reach USD 1.10 billion by 2029, growing at a CAGR of 2.30% from 2024.
  • Key Drivers: Increasing prevalence of allergies, motion sickness, and insomnia, along with rising cold and flu cases.
  • Regional Dominance: North America holds the largest market share, while Asia-Pacific is the fastest-growing region.
  • Major Players: Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd.
  • Challenges: Side effects such as anticholinergic toxicity and the need for proper patient education.
  • Accessibility: Availability as an OTC medication enhances its market growth.

FAQs

Q1: What is the current market size of the diphenhydramine market?

The diphenhydramine market size is estimated at USD 0.99 billion in 2024[1][3].

Q2: Which region is expected to be the fastest-growing market for diphenhydramine?

The Asia-Pacific region is expected to be the fastest-growing market for diphenhydramine[1][3].

Q3: What are the major side effects of diphenhydramine that could hinder market growth?

The major side effects include anticholinergic toxicity, respiratory failure, arrhythmias, and cardiac arrest[2].

Q4: How does the availability of diphenhydramine as an OTC medication impact its market growth?

The availability of diphenhydramine as an OTC medication enhances its accessibility, making it a preferred choice for consumers without the need for a prescription, thus boosting sales and market growth[1][3].

Q5: What is the projected CAGR for the global diphenhydramine hydrochloride market in terms of volume until 2034?

The global diphenhydramine hydrochloride market is anticipated to grow at a CAGR of 3.5% until 2034[4].

Sources

  1. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis.
  2. NCBI Bookshelf: Diphenhydramine Toxicity - StatPearls.
  3. Mordor Intelligence: Diphenhydramine Market Size (2024 - 2029).
  4. ChemAnalyst: Diphenhydramine Hydrochloride Market Size, Share & Forecast to 2034.
  5. Financial Express: We have made strategic choices for Indian market to grow, scale and meet unmet needs of consumers.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.