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Last Updated: January 2, 2025

HYDRAMINE Drug Patent Profile


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Which patents cover Hydramine, and when can generic versions of Hydramine launch?

Hydramine is a drug marketed by Alpharma Us Pharms and is included in two NDAs.

The generic ingredient in HYDRAMINE 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hydramine

A generic version of HYDRAMINE was approved as diphenhydramine hydrochloride by WEST-WARD PHARMS INT on December 31st, 1969.

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Summary for HYDRAMINE
Drug patent expirations by year for HYDRAMINE
Recent Clinical Trials for HYDRAMINE

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

SponsorPhase
Hamad Medical CorporationPhase 4

See all HYDRAMINE clinical trials

US Patents and Regulatory Information for HYDRAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Us Pharms HYDRAMINE diphenhydramine hydrochloride ELIXIR;ORAL 080763-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alpharma Us Pharms HYDRAMINE diphenhydramine hydrochloride SYRUP;ORAL 070205-001 Jan 28, 1986 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

HYDRAMINE Market Analysis and Financial Projection

Diphenhydramine Market Dynamics and Financial Trajectory

Market Overview

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 other conditions such as motion sickness and insomnia. Here’s a detailed look at the market dynamics and financial trajectory of diphenhydramine.

Market Size and Growth

The diphenhydramine market is projected to experience steady growth over the forecast period. As of 2024, the market size is estimated at 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%[1][3].

For a longer-term perspective, another forecast suggests that the market could reach USD 746.73 million by 2030, growing at a CAGR of 4.0% from 2023 to 2030[5].

Market Drivers

Growing Number of Allergic Populations

The increasing prevalence of allergies due to environmental changes and rising pollution levels is a significant driver for the diphenhydramine market. For instance, approximately 25.7% of US adults reported experiencing seasonal allergies in 2022, according to the Centers for Disease Control and Prevention[1][3].

Rising Prevalence of Motion Sickness and Insomnia

The high burden of motion sickness and insomnia also fuels the demand for diphenhydramine. In North America, more than 35% of Canadians and between 10% and 30% of US adults struggle with chronic insomnia, making diphenhydramine a sought-after medication for its sedative properties[1].

Increasing Research and Development Expenditures

The market is further boosted by increasing research and development expenditures aimed at exploring new applications and formulations of diphenhydramine. This includes developing new dosage forms and improving the efficacy of existing treatments[1][3].

Market Restraints

Side Effects of Diphenhydramine

Despite its widespread use, diphenhydramine has several side effects, such as drowsiness, dry mouth, and constipation, which can act as market restraints. These side effects may lead some consumers to seek alternative treatments, potentially slowing market growth[3].

Geographical Analysis

North America

North America holds the largest market share for diphenhydramine, driven by the high burden of allergies and insomnia in the region. The well-established healthcare infrastructure and high healthcare expenditure in this region also contribute to its dominance[1][3].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market for diphenhydramine, driven by factors such as increasing healthcare accessibility, a rising prevalence of allergies, and shifting consumer behavior towards self-medication. Countries like China and India are key contributors to this growth[1][4].

Europe and Other Regions

Europe and other regions, including the Middle East, Africa, and Latin America, also show significant growth potential. These regions are influenced by varying healthcare infrastructure, awareness levels, and economic factors, but are gradually expanding due to growing urbanization and improving access to medications[4][5].

Market Segmentation

By Dosage Forms

The diphenhydramine market is segmented by dosage forms, including tablets, injections, powders, and syrups. Each form caters to different patient preferences and medical needs, contributing to the market's diversification[3][5].

By Application

The market is also segmented by application, with key segments including allergies, insomnia, cold, nausea, and other applications. The effectiveness of diphenhydramine in treating a wide range of symptoms enhances its demand across these segments[3][5].

Competitive Landscape

The diphenhydramine market is characterized by a medium level of market concentration, with several major players operating in the space. Key players include:

  • Fresenius Kabi
  • Johnson & Johnson
  • PAI Pharma
  • Pfizer Inc.
  • Souvin Pharmaceuticals Pvt. Ltd.
  • Atom Pharma
  • Bayer Healthcare
  • S.S. Pharmachem
  • Remedy Labs
  • Amar Healthcare[1][4]

These companies engage in strategic collaborations and product innovations, ensuring a dynamic and evolving market environment.

Price Dynamics

The prices of diphenhydramine hydrochloride are expected to rise moderately in the near future, driven by steady demand from the pharmaceutical and healthcare sectors, coupled with constrained supply. Seasonal changes, such as the allergy season, further drive this trend, leading manufacturers and suppliers to adjust prices accordingly[2].

Global events, such as the Mid-Autumn Festival in China and potential labor strikes at U.S. ports, can also influence supply chain dynamics and prices. Additionally, economic factors like consumer sentiment and monetary policies can impact demand and prices[2].

Key Takeaways

  • The diphenhydramine 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%.
  • The market is driven by the growing number of allergic populations, rising prevalence of motion sickness and insomnia, and increasing research and development expenditures.
  • North America holds the largest market share, while the Asia-Pacific region is the fastest-growing market.
  • The market is segmented by dosage forms and applications, with key players engaging in strategic collaborations and product innovations.
  • Price dynamics are influenced by seasonal demand, supply chain disruptions, and economic factors.

FAQs

What is the current market size of the diphenhydramine market?

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

Which region is the fastest-growing market for diphenhydramine?

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

What are the major drivers of the diphenhydramine market?

The major drivers include the growing number of allergic populations, rising prevalence of motion sickness and insomnia, and increasing research and development expenditures[1][3].

Who are the key players in the diphenhydramine market?

Key players include Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd., among others[1][4].

Why are diphenhydramine prices expected to rise?

Diphenhydramine prices are expected to rise due to steady demand, constrained supply, seasonal changes, and potential supply chain disruptions[2].

Sources

  1. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis
  2. ChemAnalyst: Allergy Season Squeeze: Diphenhydramine Hydrochloride Prices Set to Soar in September
  3. Mordor Intelligence: Diphenhydramine Market Size (2024 - 2029)
  4. Verified Market Research: Diphenhydramine Market size was valued at USD 108 Bn in 2023 and is projected to reach USD 145 Bn by 2031
  5. Reanin: Global Diphenhydramine Market | Growth | Share | Size | Trends and Forecast

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