Diphenhydramine hydrochloride - Generic Drug Details

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

Diphenhydramine hydrochloride is the generic ingredient in seventeen branded drugs marketed by Mcneil Cons, Alra, Anabolic, Elkins Sinn, Fosun Pharma, Halsey, Heather, Heritage Pharma, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Cenci, Usl Pharma, Bundy, Kv Pharm, Naska, Pharm Assoc, Alpharma Us Pharms, App Pharms, Bel Mar, Dr Reddys, Gland Pharma Ltd, Hikma, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Parke Davis, Morton Grove, Cumberland Swan, Sciegen Pharms Inc, Lannett Co Inc, Warner Chilcott, Haleon Us Holdings, Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Bayer Hlthcare, Amneal Pharms Co, Corepharma, Granules, P And L, and Perrigo R And D, and is included in one hundred NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for diphenhydramine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for diphenhydramine hydrochloride

US Patents:	0
Tradenames:	17
Applicants:	67
NDAs:	100
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	304
What excipients (inactive ingredients) are in diphenhydramine hydrochloride?	diphenhydramine hydrochloride excipients list
DailyMed Link:	diphenhydramine hydrochloride at DailyMed

See drug sales revenues for diphenhydramine hydrochloride

Recent Clinical Trials for diphenhydramine hydrochloride

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Washington University School of Medicine	Phase 2
Assertio Holdings, Inc	Phase 2

See all diphenhydramine hydrochloride clinical trials

Pharmacology for diphenhydramine hydrochloride

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for diphenhydramine hydrochloride

Anesthetics, Local

Anti-Allergic Agents

Antiemetics

Histamine H1 Antagonists

Hypnotics and Sedatives

Sleep Aids, Pharmaceutical

Anatomical Therapeutic Chemical (ATC) Classes for diphenhydramine hydrochloride

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

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

US Patents and Regulatory Information for diphenhydramine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fosun Pharma	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	080832-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	091526-001	Mar 26, 2013	AP	RX	No	No
Lannett	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	080868-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	083797-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	083797-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Purepac Pharm	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	085156-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Usl Pharma	DIPHEN	diphenhydramine hydrochloride	ELIXIR;ORAL	084640-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Diphenhydramine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diphenhydramine Hydrochloride

Market Size and Growth Projections

The diphenhydramine hydrochloride market is poised for steady growth over the coming years. As of 2024, the market size is estimated to be approximately USD 0.99 billion and is expected to reach USD 1.10 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 2.30% during the forecast period[1][3].

Key Drivers of Market Growth

Increasing Prevalence of Allergies

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

Growing Incidence of Motion Sickness

Motion sickness, particularly among international travelers, is another factor driving the market. With an estimated 66.5 million tourists traveling internationally in the United States in 2023, the demand for motion sickness medications, including diphenhydramine, is on the rise[1].

Rising Prevalence of Insomnia

The increasing prevalence of insomnia and sleep disorders, exacerbated by modern lifestyles and an aging population, is also boosting the market. Diphenhydramine's use as a sedative to aid sleep is becoming more common, contributing to the market's growth[1][4].

Availability and Accessibility

Diphenhydramine's availability as an over-the-counter (OTC) medication enhances its accessibility, further propelling its demand. This ease of access without the need for a prescription is a significant factor in the market's expansion[1][3].

Regional Market Dynamics

North America

North America is anticipated to hold the largest market share during the forecast period. This is due to the high burden of allergies and insomnia in the region, as well as the increasing number of international travelers experiencing motion sickness. For example, around 25 metropolitan areas in the US are under the high-risk category for allergy attacks, according to the Asthma and Allergy Foundation of America[1][3].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market for diphenhydramine hydrochloride. The growing population, increasing awareness of health issues, and rising healthcare expenditures in this region are driving the demand for antihistamines and sleep aids[1][3].

Market Concentration and Competitive Landscape

The diphenhydramine market has a medium level of concentration, with several key players dominating the market. Companies such as Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd are major players in this market. The competitive landscape is characterized by strategic collaborations and product innovations, ensuring a dynamic and evolving market environment[1][3].

Product Formulations and Applications

Diphenhydramine hydrochloride is available in various formulations, including tablets, capsules, and syrups. The market is segmented based on these types and applications such as allergic reactions, motion sickness, and sleep aid. The versatility of diphenhydramine in treating different conditions is a key factor in its market growth[4].

Technological and Formulation Advancements

Advancements in pharmaceutical formulations and drug delivery technologies are also driving the market expansion. These developments improve the effectiveness and applicability of diphenhydramine hydrochloride, making it a preferred choice for consumers and healthcare professionals[4].

Challenges and Limitations

Despite the positive growth trajectory, the diphenhydramine market faces challenges, particularly related to the side effects of the drug. These side effects can hinder the market growth during the forecast period. However, the overall benefits and widespread use of diphenhydramine are expected to outweigh these limitations[1][3].

Financial Projections Beyond 2029

Looking beyond the 2029 forecast, the diphenhydramine hydrochloride market is expected to continue its growth. According to a longer-term projection, the market size is anticipated to reach USD 568.16 million by 2031, growing at a CAGR of 9.25% from 2024 to 2031. This growth is driven by the increasing global need for potent antihistamines, the rising prevalence of sleep disorders, and advancements in pharmaceutical formulations[4].

Key Takeaways

• The diphenhydramine hydrochloride market is expected to grow from USD 0.99 billion in 2024 to USD 1.10 billion by 2029.
• Key drivers include the increasing prevalence of allergies, motion sickness, and insomnia.
• North America holds the largest market share, while the Asia-Pacific region is the fastest-growing market.
• The market is driven by the availability of diphenhydramine as an OTC medication and advancements in pharmaceutical formulations.
• Despite side effects, the market is expected to continue growing beyond 2029.

FAQs

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

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

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

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

What are the primary applications of diphenhydramine hydrochloride?

The primary applications include treating allergic reactions, motion sickness, and aiding sleep[1][4].

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].

What are the challenges facing the diphenhydramine hydrochloride market?

The primary challenge is the potential side effects of diphenhydramine, which could hinder market growth[1][3].

Sources

1. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis.
2. University of Maryland, Baltimore: Diphenhydramine hydrochloride - Summary Report.
3. Mordor Intelligence: Diphenhydramine Market Size (2024 - 2029).
4. Market Research Intellect: Diphenhydramine Hydrochloride Market Size and Projections.
5. DrugBank: Diphenhydramine: Uses, Interactions, Mechanism of Action.