CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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

Constraining patent/regulatory exclusivity:

7,863,287

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

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

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	ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	021441-001	Dec 19, 2002		OTC	Yes	Yes	7,863,287		Y
Haleon Us Holdings	CHILDREN'S ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	SUSPENSION;ORAL	021587-001	Feb 24, 2004		OTC	Yes	Yes

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

International Patents for CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	200413004	Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines
South Africa	200504908	Compositions of non-steroidal anti-inflammatory drugs decongestants and anti-histamines
Japan	2008501692
Taiwan	I313598
European Patent Office	1755561	COMPRIME MULTICOUCHE COMPRENANT DES MEDICAMENTS ANTI-INFLAMMATOIRES NON STEROIDIENS, DES DECONGESTIONNANTS ET DES ANTIHISTAMINIQUES NON SEDATIFS (MULTI-LAYER TABLET COMPRISING NON-STEROIDAL ANTI-INFLAMMATORY DRUGS DECONGESTANTS AND NON-SEDATING ANTIHISTAMINES)
Australia	2011200912	Multi-layer tablet comprising non-steroidal anti-inflammatory drugs, decongestants and non-sedating antihistamines
Chile	2003002653	COMPOSICION FARMACEUTICA QUE COMPRENDE (A) UN ANTIINFLAMATORIO NO ESTEROIDAL (NSAID), PREFERENTEMENTE IBUPROFENO, (B) UN DESCONGESTIONANTE, PREFERENTEMENTE PSEUDOEFEDRINA Y (C) UN ANTIHISTAMINICO, PREFERENTEMENTE CLORFENIRAMINA; METODO PARA SU PREPAR

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].