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Last Updated: March 11, 2025

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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

Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride has thirty-four patent family members in eighteen countries.

One supplier is listed for this compound.

Summary for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
International Patents:34
US Patents:1
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
DailyMed Link:CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Generic Entry Date for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE 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
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
R03CA Alpha- and beta-adrenoreceptor agonists
R03C ADRENERGICS FOR SYSTEMIC USE
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
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

US Patents and Regulatory Information for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE 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 CHILDREN'S ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021587-001 Feb 24, 2004 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Haleon Us Holdings ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 021441-001 Dec 19, 2002 OTC Yes Yes 7,863,287 ⤷  Try for Free Y ⤷  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

Expired US Patents for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Haleon Us Holdings CHILDREN'S ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021587-001 Feb 24, 2004 10,238,640 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Australia 2005251733 Multi-layer tablet comprising non-steroidal anti-inflammatory drugs decongestants and non-sedating antihistamines ⤷  Try for Free
Japan 5241228 ⤷  Try for Free
Taiwan 200413004 Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines ⤷  Try for Free
New Zealand 540289 Pharmaceutical compositions of non-steroidal anti-inflammatory drugs (NSAID), decongestants and anti-histamines ⤷  Try for Free
Russian Federation 2005122403 КОМПОЗИЦИИ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ, ПРОТИВОЗАСТОЙНЫХ СРЕДСТВ И АНТИГИСТАМИНОВ ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Chlorpheniramine Maleate, Ibuprofen, and Pseudoephedrine Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

The pharmaceutical market is witnessing significant growth driven by the increasing prevalence of various health conditions, advancements in research, and the development of innovative formulations. This article focuses on the market dynamics and financial trajectory of three key drugs: chlorpheniramine maleate, ibuprofen, and pseudoephedrine hydrochloride.

Chlorpheniramine Maleate Market Dynamics

Market Size and Growth

The global chlorpheniramine maleate market was valued at approximately USD 471 million in 2022 and is projected to reach USD 744 million by 2032, growing at a CAGR of 4.8% from 2023 to 2032[1][4].

Key Drivers

  • Increasing Prevalence of Allergies: The rise in allergic conditions such as allergic rhinitis (hay fever) and other respiratory allergies is a significant driver. For instance, around 81 million people in the U.S. were diagnosed with seasonal allergic rhinitis in 2021[4].
  • Advancements in Pharmaceutical Research: Continuous R&D activities and the development of new formulations like extended-release tablets and liquid formulations are enhancing the market's growth[4].
  • Geographical Expansion: North America currently leads the market, but the Asia-Pacific region is expected to experience the highest growth rate due to increasing consumer awareness and the rise in allergic conditions[1][4].

Market Restraints

  • Side Effects: Potential adverse effects such as drowsiness, dry mouth, blurred vision, and urinary retention can hamper market growth[4].
  • Shift to Alternative Medicines: Changes in consumer preferences towards natural remedies and holistic approaches can also restrain the market[4].

Ibuprofen Market Dynamics

Market Overview

Ibuprofen, a widely used nonsteroidal anti-inflammatory drug (NSAID), is often combined with other medications like pseudoephedrine hydrochloride and chlorpheniramine maleate for treating various conditions.

Key Drivers

  • Combination Products: Ibuprofen is frequently used in combination products, such as those containing pseudoephedrine hydrochloride or chlorpheniramine maleate, which are marketed as over-the-counter (OTC) products for treating colds, allergies, and pain[3].
  • Broad Therapeutic Use: Ibuprofen's efficacy in treating pain, inflammation, and fever makes it a staple in many households, contributing to its stable market presence.

Market Restraints

  • Generic Competition: The availability of generic ibuprofen can reduce the market share of branded products.
  • Side Effects: Long-term use of ibuprofen can lead to gastrointestinal issues and other side effects, which may influence consumer choices.

Pseudoephedrine Hydrochloride Market Dynamics

Market Size and Growth

While specific financial projections for pseudoephedrine hydrochloride are not detailed, it is a key component in the decongestants market, which is estimated to reach $21.3 billion by 2027, growing at a CAGR of 6.3% from 2022 to 2027[5].

Key Drivers

  • Decongestant Market Growth: Pseudoephedrine hydrochloride is a primary ingredient in many decongestants, and the increasing demand for these products, especially in the form of nasal sprays, drives its market growth[5].
  • Geographical Expansion: North America and the Asia-Pacific region are significant markets, with the latter expected to grow at the fastest CAGR due to increasing cases of nasal congestion and the preference for nasal sprays[5].

Market Restraints

  • Side Effects and Regulatory Issues: Pseudoephedrine hydrochloride has been linked to heart-related side effects, and its use is sometimes restricted due to its potential for misuse in the production of illicit drugs[5].

Financial Trajectory

Chlorpheniramine Maleate

  • The market is expected to grow from USD 471 million in 2022 to USD 744 million by 2032, with a CAGR of 4.8%[1][4].

Ibuprofen

  • While specific financial projections for ibuprofen alone are not provided, its widespread use and inclusion in combination products ensure a stable market presence. The overall pain relief and anti-inflammatory market, which includes ibuprofen, is substantial and continues to grow.

Pseudoephedrine Hydrochloride

  • As part of the decongestants market, pseudoephedrine hydrochloride contributes to the estimated $21.3 billion market size by 2027, with a CAGR of 6.3% from 2022 to 2027[5].

Regional Analysis

Chlorpheniramine Maleate

  • North America leads the market, holding more than 38% of the market share in 2022. The Asia-Pacific region is expected to witness significant growth due to increasing prevalence of allergic conditions and rising consumer awareness[1][4].

Ibuprofen

  • Ibuprofen's market is global, with significant presence in North America, Europe, and the Asia-Pacific region. Its use in combination products further expands its geographical reach.

Pseudoephedrine Hydrochloride

  • North America holds the largest share in the decongestants market, but the Asia-Pacific region is expected to grow at the fastest rate due to increasing demand for nasal sprays and other decongestant products[5].

Competitive Landscape

Chlorpheniramine Maleate

  • Key market players include Capellon Pharmaceuticals, GlaxoSmithKline plc, Viatris Inc., Johnson & Johnson, Sun Pharmaceutical Industries Limited, and others[4].

Ibuprofen

  • Major pharmaceutical companies such as Pfizer, Johnson & Johnson, and others dominate the ibuprofen market, both in branded and generic forms.

Pseudoephedrine Hydrochloride

  • The decongestants market, which includes pseudoephedrine hydrochloride, is competitive with top companies adopting strategies like novel product launches, mergers, and R&D activities to maintain market share[5].

Key Takeaways

  • The chlorpheniramine maleate market is driven by the increasing prevalence of allergies and advancements in pharmaceutical research, with a projected market size of USD 744 million by 2032.
  • Ibuprofen's market stability is ensured by its broad therapeutic use and inclusion in combination products.
  • Pseudoephedrine hydrochloride, as part of the decongestants market, is expected to grow significantly, driven by the demand for nasal sprays and other decongestant products.
  • Regional growth varies, with North America leading in chlorpheniramine maleate and decongestants markets, while the Asia-Pacific region shows the highest growth potential.

FAQs

What is chlorpheniramine maleate used for?

Chlorpheniramine maleate is an antiallergic medicine used to treat various allergic conditions such as allergic rhinitis (hay fever), relieving symptoms like red, itchy, watery eyes, sneezing, and runny nose[4].

What are the key drivers of the chlorpheniramine maleate market?

The key drivers include the increasing prevalence of allergies, advancements in pharmaceutical research, and the development of new formulations[1][4].

What are the potential side effects of pseudoephedrine hydrochloride?

Pseudoephedrine hydrochloride can lead to heart-related side effects such as inflated blood pressure, palpitations, and tachycardia[5].

How does the market for ibuprofen differ from that of chlorpheniramine maleate?

Ibuprofen's market is broader due to its use in treating pain, inflammation, and fever, and it is often used in combination products, whereas chlorpheniramine maleate is more specific to allergic conditions[3].

Which region is expected to grow the fastest in the decongestants market?

The Asia-Pacific region is expected to grow at the fastest rate in the decongestants market due to increasing demand for nasal sprays and other decongestant products[5].

Sources

  1. GlobeNewswire: "Chlorpheniramine Maleate Market is forecasted to Reach USD 744 Million by 2032, growing at a 4.8% CAGR from 2023 to 2032"[1].
  2. Market Research Reports: "Global Pseudoephedrine Hydrochloride Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030"[2].
  3. FDA: "Pharmacology Review(s) - Combination products containing pseudoephedrine hydrochloride plus ibuprofen or chlorpheniramine maleate"[3].
  4. Allied Market Research: "Chlorpheniramine Maleate Market Statistics and Forecast - 2032"[4].
  5. IndustryARC: "Decongestants Market Size Report, 2022-2027"[5].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.