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Last Updated: December 22, 2024

BENADRYL Drug Patent Profile


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Which patents cover Benadryl, and what generic alternatives are available?

Benadryl is a drug marketed by Mcneil Cons and is included in three NDAs.

The generic ingredient in BENADRYL is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

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Summary for BENADRYL
Drug patent expirations by year for BENADRYL
Drug Sales Revenue Trends for BENADRYL

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Recent Clinical Trials for BENADRYL

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SponsorPhase
Washington University School of MedicinePhase 2
Assertio Holdings, IncPhase 2
Dayton Children's HospitalN/A

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US Patents and Regulatory Information for BENADRYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mcneil Cons BENADRYL diphenhydramine hydrochloride CAPSULE;ORAL 005845-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mcneil Cons BENADRYL diphenhydramine hydrochloride INJECTABLE;INJECTION 006146-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mcneil Cons BENADRYL diphenhydramine hydrochloride CAPSULE;ORAL 005845-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mcneil Cons BENADRYL diphenhydramine hydrochloride ELIXIR;ORAL 005845-004 Approved Prior to Jan 1, 1982 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

BENADRYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diphenhydramine (Benadryl)

Introduction to Diphenhydramine (Benadryl)

Diphenhydramine, commonly known by its brand name Benadryl, is an antihistamine medication widely used to relieve symptoms of allergies, hay fever, the common cold, and even sleep disorders. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global diphenhydramine market is substantial and growing. As of 2023, the market was valued at USD 567.45 million and is expected to increase to USD 746.73 million by 2030, growing at a Compounded Annual Growth Rate (CAGR) of 4.0%[1].

In another estimate, the market size is expected to reach USD 0.99 billion in 2024 and grow at a CAGR of 2.30% to reach USD 1.10 billion by 2029[3][5].

Geographical Distribution

Geographically, North America and Europe are currently the dominant regions in the diphenhydramine market, driven by well-established healthcare infrastructure, high healthcare expenditure, and increasing research and development activities. However, the Asia Pacific region is expected to witness rapid growth due to factors such as a burgeoning population, rising disposable income, and increasing awareness about healthcare[1][3].

Drivers of Market Growth

Several factors are driving the growth of the diphenhydramine market:

Increasing Prevalence of Allergies

The rising number of people suffering from seasonal allergies and allergic rhinitis is a significant driver. For instance, approximately 25.7% of US adults reported experiencing seasonal allergies in 2022[5].

Growing Geriatric Population

The increasing geriatric population, which is more prone to conditions treatable by diphenhydramine, is another key factor[1].

Rising Consumer Awareness

Increasing consumer awareness about over-the-counter (OTC) medications has led to a growing preference for self-medication, which includes diphenhydramine due to its convenience and cost-effectiveness[1].

Insomnia and Motion Sickness

The high prevalence of insomnia and motion sickness also contributes to the demand for diphenhydramine. For example, about 30% of American adults experience insomnia, and diphenhydramine is often used for its sedating effects[3].

Market Segmentation

The diphenhydramine market is segmented by dosage forms, applications, and geography.

  • Dosage Forms: Diphenhydramine is available in various forms, including tablets, capsules, and liquid formulations.
  • Applications: It is used for allergies, hay fever, the common cold, insomnia, and motion sickness.
  • Geography: The market is segmented into regions such as North America, Europe, Asia Pacific, Middle East and Africa, and Latin America[1][3].

Major Players

Key players in the diphenhydramine market include 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[3].

Financial Performance and Projections

The financial performance of the diphenhydramine market is robust and projected to continue growing.

  • Revenue Growth: The market is expected to grow from USD 0.99 billion in 2024 to USD 1.10 billion by 2029, at a CAGR of 2.30%[3][5].
  • Regional Contributions: North America holds the largest market share, while the Asia Pacific region is expected to be the fastest-growing market during the forecast period[3].

Challenges and Restraints

Despite the positive growth trajectory, the diphenhydramine market faces some challenges:

  • Side Effects: The side effects of diphenhydramine, such as drowsiness and dry mouth, can hinder market growth.
  • Regulatory Scrutiny: Changes in regulatory policies and increased scrutiny over OTC medications can also impact market dynamics[5].

Conclusion

The diphenhydramine market, driven by the widespread use of Benadryl, is poised for significant growth. Factors such as increasing allergy prevalence, a growing geriatric population, and rising consumer awareness about OTC medications are key drivers. While North America currently dominates the market, the Asia Pacific region is expected to see rapid expansion. Despite some challenges, the market's financial trajectory indicates continued growth and expansion.

Key Takeaways

  • The global diphenhydramine market is valued at USD 567.45 million in 2023 and is expected to grow to USD 746.73 million by 2030.
  • North America and Europe are the dominant regions, but the Asia Pacific is the fastest-growing market.
  • Increasing allergy prevalence, a growing geriatric population, and rising consumer awareness drive market growth.
  • Major players include Fresenius Kabi, Johnson & Johnson, and Pfizer Inc.
  • The market faces challenges such as side effects and regulatory scrutiny.

FAQs

1. What is the current market size of the diphenhydramine market?

The diphenhydramine market size is estimated at USD 0.99 billion in 2024[3][5].

2. What is the expected growth rate of the diphenhydramine market?

The market is expected to grow at a CAGR of 2.30% from 2024 to 2029[3][5].

3. Which region is the largest market for diphenhydramine?

North America holds the largest market share for diphenhydramine[3][5].

4. What are the primary drivers of the diphenhydramine market?

The primary drivers include increasing allergy prevalence, a growing geriatric population, and rising consumer awareness about OTC medications[1][3].

5. Who are the major players in the diphenhydramine market?

Major players include Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd.[3].

Cited Sources

  1. Global Diphenhydramine Market | Growth | Share | Size | Trends and Forecast - Reanin[1]
  2. ARS Pharmaceuticals Reports Third Quarter 2024 Financial Results - ARS Pharmaceuticals[2]
  3. Diphenhydramine Market Size & Share Analysis - Mordor Intelligence[3]
  4. Human Antihistamine Drug Market Size | CAGR OF 9.9% - Market.US[4]
  5. Diphenhydramine Market Size (2024 - 2029) - Mordor Intelligence[5]

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