You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

DIPHEN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Diphen patents expire, and what generic alternatives are available?

Diphen is a drug marketed by Usl Pharma, Morton Grove, 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, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Bel Mar, Dr Reddys, Gland Pharma Ltd, Hikma, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms Inc, Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Inwood Labs, Leading, Mylan, Parke Davis, R And S Pharma, Specgx Llc, Strides Pharma, Upsher Smith Labs, Winder Labs Llc, Scherer Rp, and Chartwell Molecular. and is included in one hundred and seven NDAs.

The generic ingredient in DIPHEN is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diphen

A generic version of DIPHEN was approved as phenytoin sodium by HIKMA on December 31st, 1969.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for DIPHEN?
  • What are the global sales for DIPHEN?
  • What is Average Wholesale Price for DIPHEN?
Drug patent expirations by year for DIPHEN
Drug Prices for DIPHEN

See drug prices for DIPHEN

Recent Clinical Trials for DIPHEN

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

SponsorPhase
Hospira, Inc.Phase 4
University of PennsylvaniaPhase 4
Hospira, now a wholly owned subsidiary of PfizerPhase 4

See all DIPHEN clinical trials

US Patents and Regulatory Information for DIPHEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
App Pharms DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 040466-001 May 28, 2002 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 087765-001 Mar 15, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pvt Form DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 083027-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Newtron Pharms DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 086544-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cumberland Swan DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride SYRUP;ORAL 073611-001 Aug 20, 1992 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Industries DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085506-001 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

DIPHEN Market Analysis and Financial Projection Experimental

Diphenhydramine Market Dynamics and Financial Trajectory

Introduction to Diphenhydramine

Diphenhydramine, commonly known by the brand name Benadryl, is a first-generation H1-antihistamine and sedative. Developed by George Rieveschl and introduced in 1946, it is widely used for treating allergic reactions, motion sickness, and insomnia[4].

Market Size and Growth Projections

The diphenhydramine market is anticipated to experience steady growth over the coming years. As of 2024, the market size is estimated at USD 0.99 billion and is projected 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].

Long-Term Projections

Looking further ahead, the market is expected to expand significantly. By 2031, the diphenhydramine market is projected to reach USD 145 billion, growing at a CAGR of 4.2% from 2024 to 2031. This growth is driven by increasing healthcare accessibility, rising prevalence of allergies, and shifting consumer behavior towards self-medication[5].

Key Drivers of Market Growth

Rising Prevalence of Allergies

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

Increasing Incidence of Motion Sickness and Insomnia

The rising prevalence of motion sickness and insomnia also contributes to the market's growth. Diphenhydramine's dual role as an antihistamine and sedative makes it a popular choice for treating these conditions. The insomnia segment, in particular, is anticipated to witness substantial growth due to rising stress levels, mental health issues, and an aging population[3].

Research and Development

Increasing research and development expenditures are another key factor driving the market. Efforts to explore new applications and formulations of diphenhydramine are expected to enhance its market presence and expand its user base[1][3].

Regional Market Dynamics

North America

North America is currently the largest market for diphenhydramine, driven by the high burden of allergies and insomnia in the region. The presence of major pharmaceutical companies and the high awareness of health issues among the population also contribute to its significant market share[1][3].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market for diphenhydramine. Countries like China and India are witnessing rapid growth due to increased healthcare accessibility and a rising prevalence of allergies. This region is expected to play a crucial role in the market's expansion over the coming years[1][5].

Middle East and Africa

In the Middle East and Africa, the market is influenced by varying healthcare infrastructure and awareness levels. However, the region is gradually expanding due to growing urbanization and improving access to medications. The market here is characterized by distinct trends affected by cultural, economic, and regulatory factors[5].

Latin America

Latin America is another emerging market, driven by the recognition of the benefits of over-the-counter (OTC) medications and increasing awareness about health issues such as allergies. The market in this region is expected to grow as the economies develop and healthcare access improves[5].

Competitive Landscape

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

  • Fresenius Kabi
  • Johnson & Johnson
  • Pfizer Inc.
  • Bayer Healthcare
  • Souvin Pharmaceuticals Pvt. Ltd.
  • Atom Pharma
  • Remedy Labs
  • Amar Healthcare[5]

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

Product Innovations and Combinations

Diphenhydramine is often combined with other medications to enhance its efficacy. For example, the combination of naproxen sodium and diphenhydramine hydrochloride, marketed as Aleve PM, is used for relief of occasional sleeplessness and pain. Clinical studies have shown that this combination is effective in reducing sleep latency and maintaining sleep, although it also comes with common adverse events such as dizziness, nausea, and headache[2].

Marketing and Branding

Diphenhydramine is sold under various brand names globally, including Benadryl, Nytol, Dimedrol, and Vivinox. In the US, it is also marketed as ZzzQuil by Procter & Gamble and as Sominex by Prestige Brands. These branding strategies help in increasing the market reach and consumer recognition of the product[4].

Adverse Events and Safety Concerns

While diphenhydramine is generally effective, it comes with several adverse events, including dizziness, nausea, headache, and somnolence. The sedative effects can be particularly pronounced, with somnolence lasting several hours in some cases. These safety concerns are closely monitored and addressed through regulatory reviews and clinical studies[2].

Key Takeaways

  • The diphenhydramine market is projected to grow from USD 0.99 billion in 2024 to USD 1.10 billion by 2029 at a CAGR of 2.30%.
  • Long-term projections indicate the market could reach USD 145 billion by 2031, growing at a CAGR of 4.2%.
  • Rising prevalence of allergies, motion sickness, and insomnia are key drivers of the market.
  • North America is the largest market, while the Asia-Pacific region is the fastest-growing.
  • Major players are driving innovation through strategic collaborations and product developments.
  • Adverse events and safety concerns are closely monitored to ensure safe use.

Frequently Asked Questions

Q: What is the current market size of the diphenhydramine market?

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

Q: What is the projected growth rate of the diphenhydramine market from 2024 to 2029?

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

Q: Which region is the fastest-growing market for diphenhydramine?

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

Q: What are the common adverse events associated with diphenhydramine?

Common adverse events include dizziness, nausea, headache, and somnolence[2].

Q: Which companies are major players in the diphenhydramine market?

Major players include Fresenius Kabi, Johnson & Johnson, Pfizer Inc., Bayer Healthcare, and others[5].

Sources

  1. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis.
  2. FDA: N205-352 Naproxen & Diphenhydramine Clinical PREA.
  3. Mordor Intelligence: Diphenhydramine Market Size (2024 - 2029).
  4. Wikipedia: Diphenhydramine.
  5. Verified Market Research: Diphenhydramine Market Size And Forecast.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.