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Last Updated: December 26, 2024

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Ibuprofen And Pseudoephedrine Hydrochloride, and what generic alternatives are available?

Ibuprofen And Pseudoephedrine Hydrochloride is a drug marketed by Aurobindo Pharma, Perrigo, Aurobindo Pharma Ltd, Contract Pharmacal, and Dr Reddys Labs Ltd. and is included in five NDAs.

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

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

A generic version of IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE was approved as ibuprofen; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on August 14th, 2006.

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  • What is the 5 year forecast for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE?
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Summary for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Drug patent expirations by year for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Recent Clinical Trials for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

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

SponsorPhase
Pharma Medica Research, Inc.Phase 1
Institut für Pharmakologie und Präventive MedizinPhase 1
Boehringer IngelheimPhase 1

See all IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

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 PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235-001 Dec 1, 2017 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Contract Pharmacal IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 075588-001 Apr 8, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 076478-001 Nov 5, 2003 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

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ibuprofen and Pseudoephedrine Hydrochloride

Introduction

Ibuprofen and pseudoephedrine hydrochloride, a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a nasal decongestant, is widely used for the temporary relief of symptoms associated with the common cold, flu, and other respiratory conditions. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The global market for ibuprofen, a key component of this combination, is substantial and growing. As of 2023, the global ibuprofen market was valued at USD 1.43 billion 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].

Regional Market Analysis

Asia Pacific

The Asia Pacific region is the largest market for ibuprofen and is expected to expand significantly. This growth is driven by cost-efficient manufacturing in countries like China and India, where production costs are notably low. The region also witnesses a surge in healthcare expenditures, with India's aging population contributing to the increased demand for pain management solutions, including ibuprofen[3].

North America

North America is the fastest-growing market for ibuprofen. The region's growth is fueled by rising public awareness of chronic diseases, increasing healthcare spending, and the trend toward self-medication for minor ailments[3].

Application and End-User Segmentation

Application

Ibuprofen and pseudoephedrine hydrochloride are primarily used for the relief of symptoms associated with the common cold, including nasal congestion, headache, fever, and minor body aches and pains. The combination is also effective in managing pain and inflammation related to rheumatoid arthritis and osteoarthritis, which are significant drivers of the market[3][4].

End-Users

The pharmaceutical and biopharmaceutical companies segment holds the highest market share. These companies are driving the demand for ibuprofen API due to their increasing focus on safety, efficacy, and the treatment of previously incurable diseases. Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) also play a crucial role in the development and production of these drugs[3].

Financial Trajectory

Revenue and Market Share

The financial trajectory of ibuprofen and pseudoephedrine hydrochloride is closely tied to the overall ibuprofen market. With a projected market size of USD 1.76 billion by 2032, companies manufacturing this combination are likely to see significant revenue growth. The Asia Pacific region, being the largest market, will contribute substantially to this revenue[3].

Key Players and Investments

Companies like IOL Chemicals & Pharmaceuticals are investing heavily in capital expenditures to establish new manufacturing facilities and diversify their product portfolios. For instance, IOL Chemicals & Pharmaceuticals invested INR 300 crore in 2022 to set up a plant in western India, which is expected to bolster the company's revenue from ibuprofen and related products[3].

Safety and Regulatory Considerations

Side Effects and Warnings

The combination of ibuprofen and pseudoephedrine hydrochloride comes with several safety considerations. It can cause serious side effects such as stomach bleeding, heart attack, and stroke. Additionally, pseudoephedrine can lead to rare but serious conditions like posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), especially in patients with uncontrolled high blood pressure or severe kidney disease[1][5].

Regulatory Updates

The European Medicines Agency (EMA) has endorsed measures to minimize the risks associated with pseudoephedrine-containing medicines, including updates to product information and restrictions on use in certain patient groups. These regulatory changes are crucial for ensuring the safe use of these medications[1].

Market Drivers

Increasing Healthcare Expenditures

Rising healthcare expenditures globally, particularly in the Asia Pacific region, are driving the demand for ibuprofen and pseudoephedrine hydrochloride. This trend is expected to continue, fueled by growing public awareness of chronic diseases and the need for effective pain management solutions[3].

Aging Population

The aging population, especially in countries like India, is more prone to multiple chronic illnesses, which increases the demand for pain management drugs like ibuprofen and pseudoephedrine hydrochloride[3].

Self-Medication Trends

The trend toward self-medication for minor ailments is another significant driver. Consumers are increasingly opting for over-the-counter (OTC) medications, which includes combination products like ibuprofen and pseudoephedrine hydrochloride[3].

Market Challenges

Safety Concerns

The potential for serious side effects, such as gastrointestinal bleeding and cardiovascular risks, poses a significant challenge. These risks necessitate careful patient selection and monitoring, which can impact market growth[1][5].

Regulatory Hurdles

Stringent regulatory requirements and updates, such as those implemented by the EMA, can affect the market dynamics. Companies must comply with these regulations, which can be time-consuming and costly[1].

Competitive Landscape

The market for ibuprofen and pseudoephedrine hydrochloride is competitive, with several pharmaceutical and biopharmaceutical companies vying for market share. Strategic initiatives such as partnerships, product launches, and acquisitions are common among key players to maintain and expand their market presence[3].

Conclusion

The market for ibuprofen and pseudoephedrine hydrochloride is driven by a combination of factors including increasing healthcare expenditures, an aging population, and trends toward self-medication. However, it also faces challenges related to safety concerns and regulatory hurdles. As the global ibuprofen market continues to grow, companies manufacturing this combination are poised for significant revenue growth, particularly in the Asia Pacific region.

Key Takeaways

  • The global ibuprofen market is projected to reach USD 1.76 billion by 2032.
  • The Asia Pacific region is the largest and fastest-growing market for ibuprofen.
  • Safety concerns and regulatory updates are critical for the safe use of ibuprofen and pseudoephedrine hydrochloride.
  • Increasing healthcare expenditures and an aging population drive the demand for these drugs.
  • Self-medication trends and strategic initiatives by key players are key market drivers.

FAQs

What are the primary applications of ibuprofen and pseudoephedrine hydrochloride?

The primary applications include the temporary relief of symptoms associated with the common cold, flu, and other respiratory conditions, as well as managing pain and inflammation related to rheumatoid arthritis and osteoarthritis.

What are the potential side effects of ibuprofen and pseudoephedrine hydrochloride?

Potential side effects include stomach bleeding, heart attack, stroke, and rare conditions like posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Which region is the largest market for ibuprofen?

The Asia Pacific region is the largest market for ibuprofen, driven by cost-efficient manufacturing and increasing healthcare expenditures.

What regulatory measures have been taken for pseudoephedrine-containing medicines?

The European Medicines Agency (EMA) has endorsed measures to minimize the risks associated with pseudoephedrine-containing medicines, including updates to product information and restrictions on use in certain patient groups.

How does the aging population impact the demand for ibuprofen and pseudoephedrine hydrochloride?

The aging population is more prone to multiple chronic illnesses, which increases the demand for pain management solutions like ibuprofen and pseudoephedrine hydrochloride.

Sources

  1. EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine. European Medicines Agency.
  2. Annual Report 2001. Beximco Pharmaceuticals Limited.
  3. Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report. Straits Research.
  4. Ibuprofen + Pseudoephedrine Caplets. Marcan Pharmaceuticals Inc.
  5. Ibuprofen and Pseudoephedrine HCl Capsules 200 mg/30 mg. DailyMed.

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