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Last Updated: April 11, 2025

ACETAMINOPHEN AND IBUPROFEN Drug Patent Profile


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

Acetaminophen And Ibuprofen is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, Marksans Pharma, and Strides Pharma. and is included in eight NDAs.

The generic ingredient in ACETAMINOPHEN AND IBUPROFEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Acetaminophen And Ibuprofen

A generic version of ACETAMINOPHEN AND IBUPROFEN was approved as acetaminophen; ibuprofen by L PERRIGO CO on February 28th, 2023.

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

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

SponsorPhase
Cairo UniversityPhase 4
Jessyka LighthallPhase 3
Rutgers, The State University of New JerseyPhase 4

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Pharmacology for ACETAMINOPHEN AND IBUPROFEN

US Patents and Regulatory Information for ACETAMINOPHEN AND IBUPROFEN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
L Perrigo Co ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 214836-001 Feb 28, 2023 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Marksans Pharma ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216994-001 Jul 10, 2023 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bionpharma ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216999-001 Aug 1, 2023 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Strides Pharma ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 217241-001 Jan 17, 2025 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Dr Reddys ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 218247-001 Aug 23, 2024 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Glenmark Pharms Ltd ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 218311-001 Apr 26, 2024 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aurobindo Pharma Ltd ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 218359-001 Mar 26, 2024 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 7 of 7 entries

Market Dynamics and Financial Trajectory for Acetaminophen and Ibuprofen

Introduction

Acetaminophen and ibuprofen are two of the most widely used over-the-counter (OTC) and prescription medications globally, utilized for pain relief, fever reduction, and inflammation. This article delves into the market dynamics and financial trajectory of these drugs, highlighting key drivers, challenges, and future projections.

Market Size and Growth Projections for Ibuprofen

Global Ibuprofen Market

The global ibuprofen market is anticipated to experience significant growth. As of 2023, the ibuprofen API market was valued at USD 700.8 million and is expected to grow at a CAGR of 1.17% from 2024 to 2030[1].

Overall Ibuprofen Market

The broader ibuprofen market, including all forms of the drug, is projected to reach USD 205.6 million by 2033, growing from USD 97 million in 2023 at a CAGR of 7.8% from 2024 to 2033[3].

Market Drivers for Ibuprofen

Increasing Chronic Pain Conditions

The rising incidence of chronic pain conditions such as rheumatoid arthritis and osteoarthritis is a significant driver for the ibuprofen market. For instance, rheumatoid arthritis affects approximately 1% of the population in India, impacting around 1 million people[1].

Growing Geriatric Population

The increasing aging population globally contributes to the demand for ibuprofen, as older individuals are more prone to conditions requiring pain management[1].

Regulatory and Market Acceptance

Intravenous (IV) ibuprofen, in particular, is gaining acceptance as an alternative to oral medications, driving its market growth. The Asia Pacific region is expected to be a key growth area due to its burgeoning healthcare industries and large patient pools[4].

Market Challenges for Ibuprofen

Regulatory Scrutiny

The pharmaceutical industry, including ibuprofen manufacturers, faces stringent regulatory standards and frequent inspections, which can pose challenges to product development and market entry[3].

Competition and Generic Availability

The availability of generic versions of ibuprofen can increase competition, affecting the market share of branded products. However, this also increases the overall adoption rate of the drug[4].

Market Size and Growth Projections for Acetaminophen

Cost-Effectiveness and Usage

While specific market size projections for acetaminophen are not detailed in the sources, its cost-effectiveness in certain medical conditions, such as knee osteoarthritis, makes it a preferred option. Acetaminophen dominates other therapies in terms of cost per gastrointestinal (GI) event averted for average-risk patients[2].

Market Drivers for Acetaminophen

Pain Management

Acetaminophen is widely used for pain management due to its efficacy and lower risk of GI adverse events compared to NSAIDs like ibuprofen. However, recent studies have raised concerns about its safety in chronic use, particularly regarding blood pressure increases[5].

Cost-Effectiveness

Acetaminophen is often the most cost-effective option for pain relief, especially for patients who do not respond to other treatments. This cost-effectiveness is a significant driver for its continued use[2].

Market Challenges for Acetaminophen

Safety Concerns

Recent studies have highlighted the potential risks of regular acetaminophen use, including an increase in systolic blood pressure by approximately 5 mm Hg in individuals with hypertension. This raises concerns about its long-term safety and efficacy[5].

Regulatory and Clinical Scrutiny

The growing evidence of potential harms associated with chronic acetaminophen use may lead to increased regulatory scrutiny and clinical caution, potentially impacting its market trajectory[5].

Regional Analysis

Ibuprofen Market

North America is a dominant region in the ibuprofen market, driven by significant healthcare expenditure, a well-established pharmaceutical industry, and a robust distribution network. The Asia Pacific region is also expected to grow rapidly due to its large patient pool and increasing healthcare investments[3].

Intravenous Ibuprofen Market

The Asia Pacific region is poised to be the fastest-growing market for intravenous ibuprofen, with countries like India, China, and Japan presenting immense opportunities due to their growing healthcare industries[4].

Competitive Landscape

Ibuprofen

The ibuprofen market is highly competitive, with various forms of the drug available, including tablets, capsules, syrups, and injections. Local manufacturers in emerging markets are gaining a competitive edge by offering low-cost, high-quality products[3].

Acetaminophen

The acetaminophen market faces competition from other pain relief medications, including NSAIDs and selective COX-2 inhibitors. However, its cost-effectiveness and widespread use continue to make it a significant player in the pain management market[2].

Financial Trajectory

Ibuprofen

The financial trajectory for ibuprofen is positive, with the global market expected to grow at a CAGR of 7.8% from 2024 to 2033. The intravenous ibuprofen market is also projected to grow significantly, reaching USD 11.13 billion by 2031 from USD 6.91 billion in 2024[3][4].

Acetaminophen

While specific financial projections for acetaminophen are not provided, its continued use and cost-effectiveness suggest a stable market presence. However, potential safety concerns and regulatory scrutiny could impact its future financial trajectory[2][5].

Key Takeaways

  • Ibuprofen Market Growth: The ibuprofen market is expected to grow significantly, driven by increasing chronic pain conditions and a growing geriatric population.
  • Acetaminophen Safety Concerns: Recent studies have raised concerns about the safety of chronic acetaminophen use, particularly regarding blood pressure increases.
  • Regional Growth: North America and the Asia Pacific region are key growth areas for both ibuprofen and intravenous ibuprofen.
  • Competitive Landscape: The market for both drugs is highly competitive, with local manufacturers in emerging markets gaining traction.
  • Financial Projections: The ibuprofen market is projected to grow at a CAGR of 7.8% from 2024 to 2033, while the financial trajectory for acetaminophen may be impacted by safety concerns.

FAQs

Q: What is the expected growth rate of the ibuprofen market from 2024 to 2033?

A: The ibuprofen market is expected to grow at a CAGR of 7.8% from 2024 to 2033[3].

Q: Which region is expected to be the fastest-growing market for intravenous ibuprofen?

A: The Asia Pacific region is expected to be the fastest-growing market for intravenous ibuprofen[4].

Q: What are the key drivers for the ibuprofen market?

A: Key drivers include increasing chronic pain conditions, a growing geriatric population, and the acceptance of intravenous ibuprofen as an alternative to oral medications[1][3][4].

Q: What are the safety concerns associated with chronic acetaminophen use?

A: Chronic acetaminophen use has been linked to an increase in systolic blood pressure by approximately 5 mm Hg in individuals with hypertension, raising concerns about its long-term safety and efficacy[5].

Q: How does the cost-effectiveness of acetaminophen compare to other pain relief medications?

A: Acetaminophen is often the most cost-effective option for pain relief, particularly in terms of averting GI events, making it a preferred choice for average-risk patients[2].

Sources

  1. Grand View Research - Ibuprofen API Market Size, Share & Growth Report, 2030
  2. PubMed - The cost-effectiveness of acetaminophen, NSAIDs, and selective ...
  3. Market.us - Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%
  4. Coherent Market Insights - Intravenous (IV) Ibuprofen Market Size & Share Analysis
  5. AHAJournals - Regular Acetaminophen Use and Blood Pressure in People With ...

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