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Last Updated: April 3, 2025

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE Drug Patent Profile


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When do Ibuprofen And Phenylephrine Hydrochloride patents expire, and when can generic versions of Ibuprofen And Phenylephrine Hydrochloride launch?

Ibuprofen And Phenylephrine Hydrochloride is a drug marketed by Perrigo R And D and is included in one NDA.

The generic ingredient in IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE is ibuprofen; phenylephrine hydrochloride. There are sixty-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ibuprofen; phenylephrine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ibuprofen And Phenylephrine Hydrochloride

A generic version of IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE was approved as ibuprofen; phenylephrine hydrochloride by PERRIGO R AND D on July 3rd, 2014.

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Summary for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Drug patent expirations by year for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Recent Clinical Trials for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

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

SponsorPhase
Ache Laboratorios Farmaceuticos S.A.Phase 3
PfizerPhase 3
Hospital Italiano de Buenos AiresPhase 4

See all IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE clinical trials

Pharmacology for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

US Patents and Regulatory Information for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Perrigo R And D IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE ibuprofen; phenylephrine hydrochloride TABLET;ORAL 203200-001 Jul 3, 2014 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Ibuprofen and Phenylephrine Hydrochloride

Introduction

Ibuprofen and phenylephrine hydrochloride are two widely used active pharmaceutical ingredients (APIs) in the healthcare industry. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) known for its analgesic, antipyretic, and anti-inflammatory properties, while phenylephrine hydrochloride is a decongestant commonly used to alleviate nasal congestion. This article delves into the market dynamics and financial trajectory of these two APIs.

Market Size and Growth Projections

Ibuprofen Market

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 Compound Annual Growth Rate (CAGR) of 2.44% during the forecast period (2024-2032)[3].

Phenylephrine Hydrochloride Market

The phenylephrine hydrochloride market was valued at USD 777.6 million in 2022 and is anticipated to reach USD 1.6 billion by 2032, with a CAGR of 7.7% during the forecast period (2023-2032)[1].

Drivers of Market Growth

Increasing Demand for Over-the-Counter (OTC) Medications

Both ibuprofen and phenylephrine hydrochloride are widely used in OTC medications. The trend towards self-medication for minor ailments, such as headaches, colds, and allergies, drives the demand for these APIs. Consumers are increasingly aware of the benefits of OTC medications, which contributes to the growth of these markets[1][3].

Rising Healthcare Expenditures

Growing healthcare expenditures, particularly in regions like Asia-Pacific, support the market growth. In Asia-Pacific, the average healthcare benefit cost trends have been rising, which fuels the demand for pharmaceuticals, including those containing ibuprofen and phenylephrine hydrochloride[3].

Seasonal and Chronic Health Conditions

Phenylephrine hydrochloride benefits from the consistent demand for decongestant medications due to seasonal factors and year-round conditions like the common cold, allergies, and sinus congestion. Similarly, ibuprofen is in high demand due to its use in treating chronic diseases such as rheumatoid arthritis, osteoarthritis, and cardiovascular diseases[1][3].

Market Segmentation

Ibuprofen Market Segmentation

The global ibuprofen market is segmented by dosage form, type, end-user, and application. The Asia-Pacific region holds the largest market share and is expected to expand substantially during the forecast period due to cost-efficient manufacturing and rising healthcare expenditures[3].

Phenylephrine Hydrochloride Market Segmentation

The phenylephrine hydrochloride market is segmented by application, mode, use, and region. The market is dominated by in-house manufacturing, which held a significant market share of 72.2% in 2022. North America is the leading region, with a business share of 38.9% in 2022, due to its diverse array of pharmaceutical manufacturers and stringent regulatory standards[1].

Competitive Landscape

Key Players in the Ibuprofen Market

The global ibuprofen market is competitive, with key players engaging in strategic initiatives such as partnerships, product launches, and acquisitions. Companies like IOL Chemicals & Pharmaceuticals are investing heavily in capital expenditures to diversify their portfolio of specialty chemicals and APIs, which includes ibuprofen[3].

Key Players in the Phenylephrine Hydrochloride Market

The phenylephrine hydrochloride market is also highly competitive, with major players like Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa holding significant market shares. These companies implement various strategies to maintain a competitive edge, including strategic acquisitions, mergers, collaborations, and partnerships[1].

Manufacturing and Production

In-House vs. Contract Manufacturing

For phenylephrine hydrochloride, in-house manufacturing is the dominant mode, offering greater flexibility and control over the production process. This segment is expected to grow at a CAGR of 7.6% over the forecast period[1].

Cost-Efficient Manufacturing

In the ibuprofen market, cost-efficient manufacturing, particularly in countries like China and India, plays a crucial role in driving market growth. Low production costs in these regions make them attractive for pharmaceutical manufacturing[3].

Regulatory Framework

Stringent Quality and Safety Standards

Both markets are regulated by stringent quality and safety standards. In North America, for instance, the manufacturing processes are overseen by agencies like the U.S. Food and Drug Administration (FDA) and Health Canada, ensuring compliance with high standards[1].

Impact of the COVID-19 Pandemic

Increased Demand for Decongestants

The COVID-19 pandemic indirectly influenced the phenylephrine hydrochloride market by increasing demand for cold and flu medications due to heightened concerns about respiratory symptoms. This led to a surge in the demand for nasal decongestant products containing phenylephrine hydrochloride[1].

Disruptions in Pharmaceutical Industry

The pandemic caused significant disruptions and shifts in the pharmaceutical industry, affecting both ibuprofen and phenylephrine hydrochloride markets. However, these disruptions also highlighted the resilience and adaptability of the industry in responding to increased demand for certain medications[1][3].

Formulations and Applications

Phenylephrine Hydrochloride Formulations

Phenylephrine hydrochloride is formulated into various nasal decongestant products, including nasal sprays, nasal drops, and oral tablets. These formulations are available both over-the-counter and by prescription, catering to individuals seeking quick relief from nasal congestion[1].

Ibuprofen Formulations

Ibuprofen is available in various dosage forms, including tablets, capsules, and liquids. It is used to treat a range of conditions, from headaches and minor aches to chronic diseases like arthritis and cardiovascular diseases[3].

Statistical Insights

  • Ibuprofen Market Size: USD 1.43 billion in 2023, projected to reach USD 1.76 billion by 2032[3].
  • Phenylephrine Hydrochloride Market Size: USD 777.6 million in 2022, anticipated to reach USD 1.6 billion by 2032[1].
  • CAGR for Ibuprofen: 2.44% during the forecast period (2024-2032)[3].
  • CAGR for Phenylephrine Hydrochloride: 7.7% during the forecast period (2023-2032)[1].

Key Takeaways

  • The markets for ibuprofen and phenylephrine hydrochloride are driven by increasing demand for OTC medications and rising healthcare expenditures.
  • Both markets are segmented by various factors, including dosage form, type, end-user, and region.
  • The competitive landscape is characterized by key players engaging in strategic initiatives to maintain market share.
  • In-house manufacturing is a significant segment for phenylephrine hydrochloride, while cost-efficient manufacturing in regions like Asia-Pacific drives the ibuprofen market.
  • The COVID-19 pandemic had a positive impact on the demand for these APIs, particularly for decongestant medications.

FAQs

What is the projected market size for ibuprofen by 2032?

The global ibuprofen market is estimated to reach USD 1.76 billion by 2032[3].

What is the primary driver of the phenylephrine hydrochloride market?

The primary driver is the consistent demand for decongestant medications in response to respiratory ailments such as the common cold, allergies, and sinus congestion[1].

How has the COVID-19 pandemic affected the phenylephrine hydrochloride market?

The pandemic increased demand for cold and flu medications, leading to a surge in the demand for nasal decongestant products containing phenylephrine hydrochloride[1].

Which region dominates the phenylephrine hydrochloride market?

North America dominates the phenylephrine hydrochloride market with a business share of 38.9% in 2022[1].

What are the key strategies employed by major players in the ibuprofen market?

Key players engage in strategic initiatives such as partnerships, product launches, and acquisitions to maintain a competitive edge in the market[3].

Sources

  1. GMI Insights: Phenylephrine Hydrochloride Market Size Report, 2032.
  2. PubChem: Ibuprofen and phenylephrine HCl.
  3. Straits Research: Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report.
  4. Wiley Online Library: Simultaneous Estimation of Ibuprofen and Phenylephrine HCl.

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