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Last Updated: December 22, 2024

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride and what is the scope of patent protection?

Chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Pharmacology for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for CHLORPHENIRAMINE MALEATE; 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
D04AA Antihistamines for topical use
D04A ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04 ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D Dermatologicals
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
R06AB Substituted alkylamines
R06A ANTIHISTAMINES FOR SYSTEMIC USE
R06 ANTIHISTAMINES FOR SYSTEMIC USE
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 CHLORPHENIRAMINE MALEATE; 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 ALLERGY AND CONGESTION RELIEF chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022113-001 Dec 21, 2011 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Haleon Us Holdings ADVIL MULTI-SYMPTOM COLD & FLU chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022113-002 Apr 28, 2017 OTC Yes Yes ⤷  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

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Chlorpheniramine Maleate, Ibuprofen, and Phenylephrine Hydrochloride

Introduction to Chlorpheniramine Maleate

Chlorpheniramine maleate, an antiallergic medicine, has been a staple in the treatment of allergic conditions since the 1950s. It is a potent alkylamine first-generation H1 antihistamine used to relieve symptoms such as red, itchy, watery eyes, sneezing, itchy nose or throat, and runny nose caused by allergies and the common cold[1][4].

Market Dynamics of Chlorpheniramine Maleate

Market Size and Growth

The chlorpheniramine maleate market was valued at $468.6 million in 2022 and is projected to reach $751.4 million by 2032, growing at a CAGR of 4.9% from 2023 to 2032. Another report estimates the market size to be $514.9 million in 2023, with a projected growth to $848.1 million by 2032 at a CAGR of 5.7%[1][2].

Driving Factors

The key drivers of the chlorpheniramine maleate market include:

  • Rise in Prevalence of Allergies: The increasing number of people diagnosed with seasonal allergic rhinitis (hay fever) and other allergic conditions is a significant factor. For instance, approximately 81 million people in the U.S. were diagnosed with seasonal allergic rhinitis in 2021[1].
  • Advances in Pharmaceutical Technology: New formulations such as extended-release tablets or liquid formulations have improved efficacy, convenience, and patient compliance[1].
  • Surge in R&D Activities: Pharmaceutical companies are investing heavily in the development of more effective antihistaminic drugs with fewer side effects[1].

Restraints

Despite the growth, the market faces several challenges:

  • Potential Side Effects: Chlorpheniramine maleate can cause drowsiness, dry mouth, blurred vision, and urinary retention, which may deter some consumers[1].
  • Shift Towards Alternative Medicines: There is a growing preference for natural remedies and holistic approaches, which can reduce demand for conventional antihistamines[1].

Market Dynamics of Ibuprofen

Overview

Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for its analgesic, anti-inflammatory, and antipyretic properties. However, specific market dynamics for ibuprofen are not detailed in the provided sources, but it is generally known that:

  • High Demand: Ibuprofen is one of the most commonly used over-the-counter (OTC) medications globally, driven by its effectiveness in treating pain, inflammation, and fever.
  • Competition: The ibuprofen market is highly competitive, with numerous generic and branded versions available. This competition can impact pricing and market share.

Driving Factors

  • Wide Range of Applications: Ibuprofen is used for various conditions, including arthritis, menstrual cramps, and general pain relief.
  • OTC Availability: Its widespread availability as an OTC medication contributes to its high demand.

Restraints

  • Side Effects and Health Concerns: Long-term use of ibuprofen can lead to gastrointestinal issues, cardiovascular risks, and other health concerns, which may influence consumer choices.
  • Regulatory Scrutiny: NSAIDs, including ibuprofen, are under continuous regulatory scrutiny due to their potential side effects.

Market Dynamics of Phenylephrine Hydrochloride

Market Size and Growth

The phenylephrine hydrochloride market was valued at USD 0.9 billion in 2023 and is expected to reach USD 1.5 billion by 2031, growing at a CAGR of 5.8% from 2024 to 2031[3].

Driving Factors

  • Increasing Incidence of Respiratory Ailments: The rising frequency of respiratory conditions such as sinusitis and allergies drives the demand for phenylephrine hydrochloride as a vasoconstrictor and decongestant[3].
  • Technological Advancements: Innovations in pharmaceutical formulations and the growth of the global pharmaceutical industry contribute to the market's expansion[3].
  • Consumer Awareness: Growing public awareness of effective remedies for cold and allergy symptoms supports the increasing demand for phenylephrine hydrochloride[3].

Restraints

  • Regulatory Hurdles: The market faces regulatory challenges that need to be addressed through innovation and strategic initiatives.
  • Competition: The decongestant market is competitive, with various products available, which can impact market share and pricing.

Financial Trajectory

Chlorpheniramine Maleate

The financial trajectory of chlorpheniramine maleate is characterized by steady growth driven by increasing demand for antihistamines and advancements in pharmaceutical technology. The market is expected to grow from $468.6 million in 2022 to $751.4 million by 2032, with a CAGR of 4.9%[1].

Phenylephrine Hydrochloride

The phenylephrine hydrochloride market is projected to grow from $0.9 billion in 2023 to $1.5 billion by 2031, at a CAGR of 5.8%. This growth is fueled by the increasing incidence of respiratory ailments and technological advancements in pharmaceutical formulations[3].

Ibuprofen

While specific financial projections for ibuprofen are not provided, it is a well-established market with high demand due to its widespread use. The market is likely to remain stable, with potential growth driven by new formulations and expanding healthcare needs.

Regional Outlook

Chlorpheniramine Maleate

  • North America: This region accounted for the majority share in 2022 and is expected to remain dominant due to advanced healthcare infrastructure and high prevalence of allergic conditions[1].
  • Asia-Pacific: This region is expected to witness the highest growth rate due to the rise in prevalence of allergic conditions, increasing consumer awareness, and growing geriatric population[1].

Phenylephrine Hydrochloride

  • Global Expansion: The market is growing globally, driven by the increasing incidence of respiratory conditions and technological advancements. Emerging markets, particularly in developing countries, offer significant growth opportunities[3].

Key Players and Competitive Landscape

Chlorpheniramine Maleate

Key players in the chlorpheniramine maleate market include Viatris Inc., Zydus Lifesciences Limited, Capellon Pharmaceuticals, Sun Pharmaceutical Industries Limited, and others. These companies are focusing on R&D activities to develop more effective antihistaminic drugs and expanding their market presence through strategic initiatives[1].

Phenylephrine Hydrochloride

The competitive landscape of the phenylephrine hydrochloride market involves various pharmaceutical companies that are innovating in drug formulations and expanding their reach in emerging markets. The market is characterized by a mix of established players and new entrants[3].

Conclusion

The markets for chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride are driven by increasing healthcare needs, technological advancements, and growing consumer awareness. While each market faces unique challenges, such as side effects and regulatory hurdles, innovation and strategic market expansions are key to sustaining growth.

Key Takeaways

  • Chlorpheniramine Maleate: Expected to grow from $468.6 million in 2022 to $751.4 million by 2032, driven by the rise in allergic conditions and advancements in pharmaceutical technology.
  • Phenylephrine Hydrochloride: Projected to grow from $0.9 billion in 2023 to $1.5 billion by 2031, driven by the increasing incidence of respiratory ailments and technological advancements.
  • Ibuprofen: Remains a highly demanded OTC medication, with growth potential driven by new formulations and expanding healthcare needs.
  • Regional Growth: North America and Asia-Pacific are key regions for chlorpheniramine maleate, while phenylephrine hydrochloride sees global growth with significant opportunities in emerging markets.

FAQs

Q: What is chlorpheniramine maleate used for? A: Chlorpheniramine maleate is used to treat various allergic conditions such as allergic rhinitis (hay fever), relieving symptoms like red, itchy, watery eyes, sneezing, itchy nose or throat, and runny nose caused by allergies and the common cold[1].

Q: What are the key drivers of the chlorpheniramine maleate market? A: The key drivers include the rise in prevalence of allergies, advances in pharmaceutical technology, and a surge in R&D activities for more effective antihistaminic drugs[1].

Q: How is the phenylephrine hydrochloride market expected to grow? A: The phenylephrine hydrochloride market is expected to grow from $0.9 billion in 2023 to $1.5 billion by 2031, at a CAGR of 5.8%, driven by the increasing incidence of respiratory ailments and technological advancements[3].

Q: What are the potential restraints for the chlorpheniramine maleate market? A: Potential side effects and a shift towards alternative medicines are significant restraints for the chlorpheniramine maleate market[1].

Q: Which regions are expected to dominate the chlorpheniramine maleate market? A: North America is expected to dominate the chlorpheniramine maleate market, followed by significant growth in the Asia-Pacific region[1].

Sources

  1. Allied Market Research - Chlorpheniramine Maleate Market Statistics and Forecast - 2032
  2. Research and Markets - Chlorpheniramine Maleate Market Report and Forecast 2024-2032
  3. Market Research Intellect - Phenylephrine Hydrochloride Market Size, Trends, Industry
  4. ResearchGate - Chlorpheniramine, an Old Drug with New Potential Clinical Applications: A Comprehensive Review of the Literature
  5. Verified Market Research - Chlorpheniramine Maleate Market Size, Share, Opportunities

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