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Last Updated: December 22, 2024

IBUPROFEN AND DIPHENHYDRAMINE CITRATE Drug Patent Profile


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Which patents cover Ibuprofen And Diphenhydramine Citrate, and what generic alternatives are available?

Ibuprofen And Diphenhydramine Citrate is a drug marketed by Aurobindo Pharma, Dr Reddys Labs Ltd, Perrigo R And D, and Pld Acquisitions Llc. and is included in four NDAs.

The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE CITRATE is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

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Summary for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
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SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1

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Pharmacology for IBUPROFEN AND DIPHENHYDRAMINE CITRATE

US Patents and Regulatory Information for IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 216204-001 May 31, 2022 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pld Acquisitions Llc IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 211404-001 Apr 11, 2024 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 090619-001 Jul 8, 2009 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo R And D IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 079113-001 Dec 22, 2008 OTC 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

IBUPROFEN AND DIPHENHYDRAMINE CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ibuprofen and Diphenhydramine Citrate

Introduction

Ibuprofen and diphenhydramine citrate are widely used medications, often combined to address various health issues such as pain, fever, and sleep disturbances. Understanding the market dynamics and financial trajectory of these drugs is crucial for stakeholders in the pharmaceutical industry.

Global Ibuprofen Market Overview

The global ibuprofen market is a significant segment within the pharmaceutical industry. Here are some key points:

  • Market Size and Growth: The global ibuprofen market was valued at USD 1.43 billion in 2023 and is projected to reach USD 1.76 billion by 2032, growing at a CAGR of 2.44% during the forecast period (2024-2032)[1].
  • Regional Dominance: The Asia-Pacific region is the largest market shareholder and is expected to expand substantially due to cost-efficient manufacturing, particularly in countries like China and India. North America is the fastest-growing market[1].

Global Diphenhydramine Market Overview

Diphenhydramine, often used in combination with ibuprofen, has its own market dynamics:

  • Market Size and Growth: The diphenhydramine market is estimated to reach USD 0.99 billion in 2024 and grow at a CAGR of 2.30% to reach USD 1.10 billion by 2029[3].
  • Regional Performance: North America holds the largest market share, while the Asia-Pacific region is the fastest-growing market due to increasing allergic populations and rising healthcare expenditures[3].

Combination Therapy: Ibuprofen and Diphenhydramine Citrate

When combined, ibuprofen and diphenhydramine citrate offer a synergistic effect, addressing multiple symptoms:

  • Indications: This combination is used to relieve trouble sleeping caused by minor aches and pains. It helps in falling asleep and staying asleep[5].
  • Formulations: Available in oral tablet form, with typical dosages including 200 mg of ibuprofen and 38 mg of diphenhydramine citrate[2][4].

Market Drivers

Several factors drive the demand for ibuprofen and diphenhydramine citrate:

  • Rising Chronic Diseases: Increasing public awareness of chronic diseases such as rheumatoid arthritis, osteoarthritis, and cardiovascular disease fuels the demand for ibuprofen[1].
  • Allergic Populations: The growing number of people suffering from seasonal allergies and other allergic conditions boosts the demand for diphenhydramine[3].
  • Healthcare Spending: Rising healthcare expenditures, especially in the Asia-Pacific region, support the growth of both markets[1][3].
  • Consumer Awareness: Growing consumer awareness about over-the-counter (OTC) medications and the trend toward self-medication for minor ailments drive the demand for both drugs[1].

Market Challenges

Despite the growth, there are challenges to consider:

  • Side Effects: Both ibuprofen and diphenhydramine citrate have potential side effects. Ibuprofen can cause gastrointestinal issues and increase the risk of cardiovascular disease, while diphenhydramine can cause drowsiness, constipation, and other adverse effects[2][5].
  • Alternative Therapies: The growing acceptance of complementary and alternative medicine (CAM) modalities for pain management may impact the market share of traditional pharmaceuticals like ibuprofen[1].

Regulatory Environment

Regulatory guidelines play a crucial role in the market dynamics:

  • FDA Guidance: The FDA provides draft guidance on the combination of diphenhydramine citrate and ibuprofen, outlining recommended studies and bioequivalence criteria to ensure the safety and efficacy of these products[4].

Key Players and Strategic Initiatives

Major pharmaceutical companies are actively involved in the market:

  • Ibuprofen Market: Companies like IOL Chemicals & Pharmaceuticals are investing heavily in capital expenditures to enhance their production capabilities and diversify their product portfolios[1].
  • Diphenhydramine Market: Key players include Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd., who are driving market growth through various strategic initiatives such as partnerships, product launches, and acquisitions[3].

Demographic Impact

Demographic changes significantly influence the demand for these medications:

  • Aging Population: The aging population, particularly in India, is more prone to multiple chronic illnesses, fueling the demand for pain management solutions like ibuprofen[1].
  • Allergic Populations: The increasing number of people suffering from seasonal allergies and other allergic conditions drives the demand for diphenhydramine[3].

Financial Projections

The financial trajectory of these drugs is promising:

  • Ibuprofen: Expected to grow from USD 1.43 billion in 2023 to USD 1.76 billion by 2032[1].
  • Diphenhydramine: Projected to grow from USD 0.99 billion in 2024 to USD 1.10 billion by 2029[3].

Key Takeaways

  • The global ibuprofen and diphenhydramine citrate markets are driven by rising chronic diseases, increasing healthcare spending, and growing consumer awareness.
  • Asia-Pacific and North America are key regions for these markets.
  • Regulatory guidelines and strategic initiatives by key players are crucial for market growth.
  • Demographic changes, such as an aging population and increasing allergic populations, significantly impact demand.
  • Despite potential side effects, the financial trajectory for both drugs is positive.

FAQs

1. What is the current market size of the global ibuprofen market? The global ibuprofen market was valued at USD 1.43 billion in 2023[1].

2. What is the projected growth rate of the diphenhydramine market from 2024 to 2029? The diphenhydramine market is expected to grow at a CAGR of 2.30% from 2024 to 2029[3].

3. Which region holds the largest market share for ibuprofen and diphenhydramine citrate? Asia-Pacific is the largest market for ibuprofen, while North America holds the largest share for diphenhydramine[1][3].

4. What are the common side effects of the combination therapy of ibuprofen and diphenhydramine citrate? Common side effects include gastrointestinal issues, drowsiness, constipation, and an increased risk of heart attack, heart failure, or stroke[2][5].

5. 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.[3].

Cited Sources:

  1. Straits Research: Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report ...
  2. DailyMed: IBUPROFEN 200 MG AND DIPHENHYDRAMINE CITRATE 38 MG
  3. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis
  4. FDA: Draft Guidance on Diphenhydramine Citrate; Ibuprofen
  5. Mayo Clinic: Diphenhydramine and ibuprofen (oral route) - Mayo Clinic

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