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Last Updated: December 22, 2024

Ibuprofen; phenylephrine hydrochloride - Generic Drug Details


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What are the generic sources for ibuprofen; phenylephrine hydrochloride and what is the scope of freedom to operate?

Ibuprofen; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and Perrigo R And D, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for ibuprofen; phenylephrine hydrochloride
Recent Clinical Trials for ibuprofen; 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; phenylephrine hydrochloride clinical trials

Pharmacology for ibuprofen; phenylephrine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for ibuprofen; phenylephrine hydrochloride
C01CA Adrenergic and dopaminergic agents
C01C CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01 CARDIAC THERAPY
C Cardiovascular system
C01EB Other cardiac preparations
C01E OTHER CARDIAC PREPARATIONS
C01 CARDIAC THERAPY
C Cardiovascular system
C05AX Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
G02CC Antiinflammatory products for vaginal administration
G02C OTHER GYNECOLOGICALS
G02 OTHER GYNECOLOGICALS
G Genito-urinary system and sex hormones
M01AE Propionic acid derivatives
M01A ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01 ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M Musculo-skeletal system
M02AA Antiinflammatory preparations, non-steroids for topical use
M02A TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02 TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M Musculo-skeletal system
R01AA Sympathomimetics, plain
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R01AB Sympathomimetics, combinations excl. corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R01BA Sympathomimetics
R01B NASAL DECONGESTANTS FOR SYSTEMIC USE
R01 NASAL PREPARATIONS
R Respiratory system
R02AX Other throat preparations
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
S01FB Sympathomimetics excl. antiglaucoma preparations
S01F MYDRIATICS AND CYCLOPLEGICS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01GA Sympathomimetics used as decongestants
S01G DECONGESTANTS AND ANTIALLERGICS
S01 OPHTHALMOLOGICALS
S Sensory organs

US Patents and Regulatory Information for ibuprofen; phenylephrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings ADVIL CONGESTION RELIEF ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022565-001 May 27, 2010 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo R And D IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE ibuprofen; phenylephrine hydrochloride TABLET;ORAL 203200-001 Jul 3, 2014 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; phenylephrine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ibuprofen and Phenylephrine Hydrochloride

Introduction to Ibuprofen and Phenylephrine Hydrochloride

Ibuprofen and phenylephrine hydrochloride are two widely used pharmaceutical compounds, each with distinct applications and market dynamics.

  • Ibuprofen: A nonsteroidal anti-inflammatory drug (NSAID) commonly used to alleviate pain, fever, and inflammation. It is available over-the-counter (OTC) and by prescription in higher doses[3].
  • Phenylephrine Hydrochloride: Primarily used in decongestant medications, this compound is crucial in the production of nasal decongestants and other respiratory relief medications[4].

Global Ibuprofen Market

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 Analysis

  • Asia-Pacific: This region is the largest shareholder in the global ibuprofen market, driven by cost-efficient manufacturing in countries like China and India. The region's healthcare expenditures are rising, and the aging population, particularly in India, is a significant factor in the increasing demand for ibuprofen[1].
  • North America: Although North America is not the largest market, it is expected to be the fastest-growing region. The robust healthcare infrastructure and high healthcare spending in this region contribute to its growth[1].

Application Segmentation

  • Rheumatoid Arthritis and Osteoarthritis: These conditions dominate the revenue share of the global ibuprofen market due to ibuprofen's potent analgesic and anti-inflammatory properties[1].
  • Other Applications: Ibuprofen is also used for pain/fever/dysmenorrhea, inflammatory diseases, headaches, and other conditions[1].

End-User Segmentation

  • Pharmaceutical and Biopharmaceutical Companies: These companies hold the highest market share due to the increasing development of ibuprofen active pharmaceutical ingredients (APIs) and the government's significant investments in the pharmaceutical industry[1].

Global Phenylephrine Hydrochloride Market

Market Size and Growth

The global phenylephrine hydrochloride market was valued at USD 777.6 million in 2022 and is anticipated to reach USD 1.6 billion by 2032, growing at a CAGR of 7.7% during the forecast period (2023-2032)[4].

Regional Analysis

  • North America: This region dominates the phenylephrine hydrochloride market with a business share of 38.9% in 2022. The presence of a diverse array of pharmaceutical manufacturers and stringent regulatory frameworks contribute to its prominence[4].

Application and Use

  • Decongestant Medications: Phenylephrine hydrochloride is primarily used in nasal decongestant medications, which saw increased demand during the COVID-19 pandemic due to heightened concerns about respiratory symptoms[4].

Key Drivers and Challenges

Ibuprofen Market Drivers

  • Rising Chronic Pain Conditions: The increasing prevalence of chronic pain conditions such as rheumatoid arthritis and osteoarthritis drives the demand for ibuprofen[3].
  • Aging Population: The growing aging population, particularly in regions like Asia-Pacific, contributes to the increased demand for pain management solutions like ibuprofen[1].

Ibuprofen Market Challenges

  • Regulatory Scrutiny: Regulatory challenges and approval processes can limit the introduction of innovative ibuprofen products to the market[3].
  • Competition from Alternative Therapies: The market faces competition from alternative pain management therapies, including prescription medications and non-pharmacological approaches[3].

Phenylephrine Hydrochloride Market Drivers

  • Increased Demand for Decongestants: The COVID-19 pandemic led to an increased demand for cold and flu medications, including those containing phenylephrine hydrochloride[4].
  • Strategic Initiatives by Key Players: Acquisitions, mergers, collaborations, and partnerships among key industry players help maintain a competitive edge in the market[4].

Phenylephrine Hydrochloride Market Challenges

  • Regulatory Frameworks: The market operates within stringent regulatory frameworks, which can influence product development timelines and market entry[4].

Competitive Landscape

Ibuprofen Market

  • The market is highly competitive, with pharmaceutical and biopharmaceutical companies playing a significant role. Companies like IOL Chemicals & Pharmaceuticals are investing heavily in capital expenditures to diversify their portfolios and bolster market share[1].

Phenylephrine Hydrochloride Market

  • Key players such as Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa hold significant market shares. These companies engage in strategic acquisitions, mergers, and collaborations to maintain their competitive edge[4].

Financial Trajectory

Ibuprofen

  • The market is expected to grow from USD 1.43 billion in 2023 to USD 1.76 billion by 2032, with a CAGR of 2.44%. This growth is driven by increasing healthcare expenditures and the rising demand for pain management solutions[1].

Phenylephrine Hydrochloride

  • The market is projected to grow from USD 777.6 million in 2022 to USD 1.6 billion by 2032, with a CAGR of 7.7%. This significant growth is attributed to the increased demand for decongestant medications and strategic initiatives by key industry players[4].

Key Takeaways

  • The ibuprofen market is driven by the increasing prevalence of chronic pain conditions and an aging population, with Asia-Pacific being the largest market.
  • The phenylephrine hydrochloride market is dominated by North America and is driven by the demand for decongestant medications.
  • Both markets face regulatory challenges but are expected to grow significantly over the forecast period.
  • Strategic initiatives by key players are crucial for maintaining a competitive edge in both markets.

FAQs

1. What is the projected market size of the global ibuprofen market by 2032? The global ibuprofen market is expected to reach USD 1.76 billion by 2032[1].

2. Which region dominates the phenylephrine hydrochloride market? North America dominates the phenylephrine hydrochloride market with a business share of 38.9% in 2022[4].

3. What are the primary applications of ibuprofen? Ibuprofen is primarily used for rheumatoid arthritis, osteoarthritis, pain/fever/dysmenorrhea, inflammatory diseases, and headaches[1].

4. How has the COVID-19 pandemic affected the phenylephrine hydrochloride market? The COVID-19 pandemic led to an increased demand for cold and flu medications, including those containing phenylephrine hydrochloride, due to heightened concerns about respiratory symptoms[4].

5. What are the key drivers of the ibuprofen market? The key drivers include the rising prevalence of chronic pain conditions and an aging population, particularly in regions like Asia-Pacific[1][3].

Cited Sources:

  1. Straits Research: Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report...
  2. PubChem: Ibuprofen and phenylephrine HCl
  3. Market.US: Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%
  4. GMI Insights: Phenylephrine Hydrochloride Market Size Report, 2032

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