DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM - Generic Drug Details

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

Diphenhydramine hydrochloride; naproxen sodium is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Amneal Pharms Co, Corepharma, Granules, P And L, and Perrigo R And D, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-two suppliers are listed for this compound.

Summary for DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	22
Clinical Trials:	9
DailyMed Link:	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM at DailyMed

Recent Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

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

Sponsor	Phase
Ciusss de L'Est de l'Île de Montréal	N/A
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM clinical trials

Pharmacology for DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	213663-001	Sep 24, 2020		OTC	No	No
P And L	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	207597-001	Jan 25, 2019		DISCN	No	No
Bayer Hlthcare	ALEVE PM	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	205352-001	Jan 17, 2014		OTC	Yes	Yes
Corepharma	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	211830-001	Aug 22, 2019		OTC	No	No

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diphenhydramine Hydrochloride

Introduction to Diphenhydramine Hydrochloride

Diphenhydramine hydrochloride is a widely used antihistamine with applications in treating allergic reactions, motion sickness, and as a sleep aid. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The diphenhydramine hydrochloride market is anticipated to experience significant growth over the next few years. As of 2024, the market size is estimated to be around USD 0.99 billion and is projected to reach USD 1.10 billion by 2029, growing at a CAGR of 2.30% during the forecast period[1].

In a more extended forecast, the market is valued at USD 279.96 million in 2023 and is expected to reach USD 568.16 million by 2031, growing at a CAGR of 9.25% from 2024 to 2031[5].

Key Drivers of Market Growth

Several factors are driving the growth of the diphenhydramine hydrochloride market:

Increasing Prevalence of Allergies

The rising number of people suffering from seasonal allergies and other allergic conditions is a significant driver. For instance, approximately 25.7% of US adults reported experiencing seasonal allergies in 2022, according to the Centers for Disease Control and Prevention[1].

Motion Sickness and Travel

The increasing number of international travelers is also boosting the demand for motion sickness medications. In 2023, an estimated 66.5 million tourists traveled internationally in the United States, a 31% increase from 2022[1].

Sleep Disorders

The growing prevalence of sleep disorders and insomnia, exacerbated by modern lifestyles, is another key factor. Diphenhydramine hydrochloride's efficacy as a sleep aid is driving its demand in this segment[5].

Environmental Factors

Rising pollution levels and changing environmental conditions are increasing the prevalence of allergies, further propelling the demand for antihistamines like diphenhydramine hydrochloride[1].

Geographical Market Analysis

North America

North America holds the largest market share in the diphenhydramine hydrochloride market, driven by the increasing number of allergic individuals and growing government initiatives. For example, around 25 metropolitan areas in the United States are under the high-risk category for allergy attacks[1].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market, driven by increasing healthcare awareness and the growing need for effective medications to treat allergies and other conditions[1].

Market Concentration and Major Players

The diphenhydramine hydrochloride market has a medium level of concentration. Major players in this market include Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd[1].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

Side Effects

The side effects of diphenhydramine hydrochloride, such as drowsiness and potential interactions with other medications, are likely to hinder market growth[1].

Regulatory Considerations

The use of diphenhydramine hydrochloride in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act is subject to FDA evaluation, which can impact market dynamics[2].

Financial Trajectory

The financial trajectory of the diphenhydramine hydrochloride market is positive, with significant growth projected over the next several years.

• Revenue Forecast: The market is expected to grow from USD 279.96 million in 2023 to USD 568.16 million by 2031, indicating a substantial increase in revenue[5].
• CAGR: The market is growing at a CAGR of 9.25% from 2024 to 2031, which is higher than the CAGR of 2.30% from 2024 to 2029, reflecting long-term growth potential[5][1].

Technological and Formulation Advancements

Advancements in pharmaceutical formulations and drug delivery technologies are also driving the market. These developments improve the effectiveness and applicability of diphenhydramine hydrochloride, making it a preferred treatment option for consumers and healthcare professionals[5].

Consumer and Healthcare Professional Preferences

The increasing awareness of sleep disorders and allergies, coupled with the availability of effective over-the-counter treatments like diphenhydramine hydrochloride, is driving consumer demand. Healthcare professionals also prefer this medication due to its efficacy and broad range of applications[1][5].

Key Takeaways

• The diphenhydramine hydrochloride market is expected to grow significantly, driven by increasing allergies, motion sickness, and sleep disorders.
• North America holds the largest market share, while the Asia-Pacific region is the fastest-growing market.
• Major players include Fresenius Kabi, Johnson & Johnson, and Pfizer Inc.
• Side effects and regulatory considerations are potential restraints.
• Technological advancements in drug delivery are enhancing market growth.

FAQs

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

The market size is estimated to be around USD 0.99 billion in 2024[1].

2. What is the projected growth rate of the diphenhydramine hydrochloride market?

The market is expected to grow at a CAGR of 2.30% from 2024 to 2029 and at a CAGR of 9.25% from 2024 to 2031[1][5].

3. Which region is the fastest-growing market for diphenhydramine hydrochloride?

The Asia-Pacific region is the fastest-growing market[1].

4. What are the major applications of diphenhydramine hydrochloride?

The major applications include treating allergic reactions, motion sickness, and as a sleep aid[1][5].

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

Major players include Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd[1].

Cited Sources:

1. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis.
2. University of Maryland, Baltimore: Diphenhydramine hydrochloride - Summary Report.
3. MarketResearchIntellect: Global Diphenhydramine Hydrochloride Market Size and Projections.