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Last Updated: December 22, 2024

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE Drug Patent Profile


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When do Diphenhydramine Hydrochloride Preservative Free patents expire, and what generic alternatives are available?

Diphenhydramine Hydrochloride Preservative Free is a drug marketed by Abraxis Pharm, Dr Reddys, Fresenius Kabi Usa, and Intl Medication. and is included in four NDAs.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE 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 Diphenhydramine Hydrochloride Preservative Free

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

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Summary for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Drug patent expirations by year for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Recent Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

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

SponsorPhase
Stamford Anesthesiology Services, PCN/A
I-FlowN/A
University of WashingtonPhase 2

See all DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE clinical trials

Pharmacology for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

US Patents and Regulatory Information for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Pharm DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 080586-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Intl Medication DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 084094-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 080873-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 091526-001 Mar 26, 2013 AP RX 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 PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Diphenhydramine Hydrochloride

Introduction to Diphenhydramine Hydrochloride

Diphenhydramine hydrochloride is an antihistamine with anticholinergic and sedative properties, widely used to alleviate symptoms of allergic reactions, including anaphylaxis, and other uncomplicated allergic conditions. It is available in various forms, including oral, injectable, and topical preparations.

Market Size and Growth

The global diphenhydramine market has shown significant growth in recent years. As of 2023, the diphenhydramine market size was valued at USD 108 billion and is projected to reach USD 145 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.2% from 2024 to 2031[3].

In terms of volume, the global diphenhydramine hydrochloride market was approximately 61 thousand tonnes in 2023 and is expected to grow at a CAGR of 3.5% during the forecast period[1].

Market Drivers

Several factors drive the demand for diphenhydramine hydrochloride:

Rising Prevalence of Allergies

The increasing exposure to allergens due to environmental changes and rising pollution levels has boosted the demand for antihistamines like diphenhydramine. This trend is expected to continue, driving market growth[3].

Expanding Product Forms

The development of new dosage forms, such as orally disintegrating tablets (ODTs), has enhanced the market appeal of diphenhydramine. These formulations offer better palatability and faster disintegration, making them more acceptable to patients[4].

Geographical Demand

North America is a prominent consumer of diphenhydramine hydrochloride, driven by a high incidence of allergic reactions and a well-established healthcare system[1].

Financial Trajectory

The financial trajectory of the diphenhydramine hydrochloride market is promising, with several key indicators:

Revenue Growth

The market is expected to grow from USD 108 billion in 2023 to USD 145 billion by 2031, indicating a robust financial outlook[3].

Investment in Research and Development

Companies are investing heavily in the development of new formulations and delivery systems, such as ODTs, which are likely to attract higher premiums and contribute to revenue growth[4].

Pricing Strategies

Real-time pricing data and benchmarking reports are crucial for companies to implement competitive pricing strategies. This helps in increasing brand presence and market share in a rapidly changing market environment[1].

Regional Analysis

North America

North America remains a significant market for diphenhydramine hydrochloride due to its large patient population and advanced healthcare infrastructure. The region's demand is driven by the high prevalence of allergic conditions and the availability of various dosage forms[1].

Other Regions

Other regions, including Europe and Asia-Pacific, are also experiencing growth due to increasing awareness of allergic conditions and improving healthcare access. These regions offer potential for future market expansion.

Competitive Landscape

The diphenhydramine hydrochloride market is competitive, with several key players involved in the production and distribution of the drug. Companies like Pfizer and Fresenius Kabi are prominent in this market, offering a range of formulations including injectable and oral forms[2][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of diphenhydramine hydrochloride. Regulatory approvals and compliance with safety standards are essential for the launch and continued sale of the drug. For instance, diphenhydramine hydrochloride injections must be inspected visually for particulate matter and discoloration before administration[2].

Challenges and Opportunities

Side Effects and Contraindications

Despite its efficacy, diphenhydramine hydrochloride has several side effects, including drowsiness, dry mouth, and potential interactions with other medications. These factors can impact patient compliance and market growth. However, these challenges also present opportunities for the development of safer and more tolerable formulations[2].

Emerging Markets

Emerging markets in regions like Asia-Pacific offer significant opportunities for growth. Increasing healthcare spending and a growing middle class in these regions are expected to drive demand for antihistamines like diphenhydramine hydrochloride.

Conclusion

The market for diphenhydramine hydrochloride is poised for continued growth driven by increasing demand for antihistamines, the development of new formulations, and expanding geographical reach. Here are some key takeaways:

  • Market Size and Growth: The global diphenhydramine market is valued at USD 108 billion in 2023 and is projected to reach USD 145 billion by 2031.
  • Market Drivers: Rising prevalence of allergies, expanding product forms, and geographical demand are key drivers.
  • Financial Trajectory: The market is expected to grow at a CAGR of 4.2% from 2024 to 2031.
  • Regional Analysis: North America is a prominent consumer, with other regions offering future growth potential.
  • Competitive Landscape: The market is competitive with key players like Pfizer and Fresenius Kabi.

Key Takeaways

  • Growing Demand: Increasing exposure to allergens drives the demand for diphenhydramine hydrochloride.
  • New Formulations: Development of ODTs and other forms enhances market appeal.
  • Geographical Expansion: North America is a key market, with opportunities in emerging regions.
  • Regulatory Compliance: Adherence to safety standards is crucial for market success.
  • Challenges and Opportunities: Side effects present challenges but also opportunities for safer formulations.

FAQs

Q1: What is the projected market size of diphenhydramine hydrochloride by 2031? The diphenhydramine market is projected to reach USD 145 billion by 2031[3].

Q2: Which region is the largest consumer of diphenhydramine hydrochloride? North America is the largest consumer of diphenhydramine hydrochloride[1].

Q3: What are the common side effects of diphenhydramine hydrochloride? Common side effects include drowsiness, dry mouth, and potential interactions with other medications[2].

Q4: What are the new formulations being developed for diphenhydramine hydrochloride? New formulations include orally disintegrating tablets (ODTs) that offer better palatability and faster disintegration[4].

Q5: What is the CAGR of the diphenhydramine hydrochloride market from 2024 to 2031? The CAGR of the diphenhydramine hydrochloride market is expected to be 4.2% from 2024 to 2031[3].

Sources

  1. ChemAnalyst - Diphenhydramine Hydrochloride Market Size, Share & Forecast to ...
  2. Pfizer - DiphenhydrAMINE Hydrochloride Injection, USP
  3. Verified Market Research - Diphenhydramine Market size was valued at USD 108 Bn in 2023 and is projected to reach USD 145 Bn by 2031
  4. ACS Publications - Expedited Development of Diphenhydramine Orally Disintegrating ...
  5. Fresenius Kabi USA - DiphenhydrAMINE Hydrochloride Injection, USP

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