CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE - Generic Drug Details

What are the generic drug sources for chlorpheniramine maleate; codeine phosphate and what is the scope of freedom to operate?

Chlorpheniramine maleate; codeine phosphate is the generic ingredient in one branded drug marketed by Mainpointe and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
DailyMed Link:	CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

Constraining patent/regulatory exclusivity:

9,107,921

Dosage:

TABLET, EXTENDED RELEASE;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; CODEINE PHOSPHATE

Drug Class	Histamine-1 Receptor Antagonist Opioid Agonist
Mechanism of Action	Full Opioid Agonists Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No	9,066,942
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No	9,107,921		Y

Expired US Patents for CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015	6,248,363
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015	6,383,471

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE Market Analysis and Financial Projection Experimental

Chlorpheniramine Maleate and Codeine Phosphate: Market Dynamics and Financial Trajectory

Market Overview

The market for chlorpheniramine maleate and codeine phosphate, often combined in medications to treat allergic symptoms and cough, is driven by several key factors.

Market Size and Growth

The chlorpheniramine maleate market, a significant component of the antihistamine 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[1].

Market Dynamics

Regional Analysis

• North America: This region accounted for the majority share of the chlorpheniramine maleate market in 2022 and is expected to remain dominant during the forecast period. This dominance is attributed to advancements in healthcare infrastructure, easy access to healthcare services, and an increase in the prevalence of allergic conditions[1].
• Asia-Pacific: This region is expected to witness the highest growth rate during the forecast period due to the rise in prevalence of allergic conditions, an increase in the number of key market players, and growing consumer awareness about allergies. Countries like India, China, Japan, and South Korea are driving this growth due to factors such as increasing air pollution, a surge in the geriatric population, and changing lifestyles[1].

Application and Indications

• Allergic Conditions: Chlorpheniramine maleate is primarily used to treat 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].
• Cough and Upper Respiratory Symptoms: When combined with codeine phosphate, the medication is indicated for the relief of cough and symptoms associated with upper respiratory allergies or the common cold. This combination is available in various formulations, including extended-release (ER) tablets and oral suspensions[2][4].

Distribution Channels

The distribution of chlorpheniramine maleate and codeine phosphate combination products is facilitated through various channels, including pharmacies, hospitals, and online platforms. The ease of access to over-the-counter (OTC) medications for allergic conditions further boosts market growth[1].

Financial Trajectory

Revenue Projections

The projected growth of the chlorpheniramine maleate market to $751.4 million by 2032 indicates a robust financial trajectory. This growth is driven by increasing demand for antihistaminic medications, a surge in the geriatric population, and rising awareness about allergies[1].

Key Market Players

Several key players are driving the market forward, including Capellon Pharmaceuticals, GlaxoSmithKline plc, Viatris Inc., Johnson & Johnson, Sun Pharmaceutical Industries Limited, Zydus Lifesciences Limited, Novalab Healthcare Pvt. Ltd., Merck & Co., Inc., Alkem Laboratories Ltd., and Bayer AG. These companies are investing in research and development (R&D) activities, which is expected to fuel market growth[1].

Competitive Analysis

Market Competition

The market for chlorpheniramine maleate and codeine phosphate combination products is competitive, with multiple players offering various formulations. The competition is driven by the need to provide effective and safe treatments for allergic conditions and cough. Companies are focusing on developing extended-release formulations to enhance patient compliance and reduce the frequency of dosing[2][4].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

• Side Effects: Potential side effects of chlorpheniramine maleate, such as drowsiness, dry mouth, blurred vision, and urinary retention, can hamper market growth[1].
• Alternative Medications: The availability of alternative medications to treat allergies can also restrain the market[1].
• Regulatory Concerns: Codeine-containing products face stringent regulatory scrutiny due to their potential for abuse and respiratory depression, particularly in pediatric patients[2][3].

Regulatory Environment

FDA Approvals and Guidelines

The FDA has approved several combination products containing codeine phosphate and chlorpheniramine maleate, including extended-release tablets and oral suspensions. These approvals are based on bioequivalence studies that demonstrate comparable systemic exposures to immediate-release formulations. However, there are strict guidelines and contraindications, especially for pediatric use, due to safety concerns[2][3][4].

Safety and Efficacy

Clinical pharmacology studies have shown that these combination products provide relief from cough and upper respiratory symptoms while maintaining safety profiles comparable to their immediate-release counterparts. However, caution is advised in patients with renal or hepatic impairment, and in elderly patients due to potential changes in drug metabolism and clearance[2][3].

Consumer Awareness and Lifestyle Factors

Increasing Awareness

Growing consumer awareness about allergies and their symptoms is a significant driver of the market. As more people recognize the need for effective treatments, the demand for chlorpheniramine maleate and codeine phosphate combination products increases[1].

Lifestyle Changes

Changes in lifestyle, including unhealthy and sedentary lifestyles, and increasing urbanization, contribute to a higher prevalence of allergic conditions. This, in turn, fuels the demand for antihistaminic and antitussive medications[1].

Key Takeaways

• The chlorpheniramine maleate market is projected to grow significantly, driven by increasing prevalence of allergic conditions and advancements in healthcare.
• Asia-Pacific is expected to witness the highest growth rate due to rising awareness and increasing air pollution.
• Combination products with codeine phosphate are crucial for treating cough and upper respiratory symptoms.
• Regulatory scrutiny, especially for codeine-containing products, is a critical factor in market dynamics.
• Consumer awareness and lifestyle changes are key drivers of market growth.

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; itchy nose or throat; and runny nose caused by allergies and the common cold[1].

What are the potential side effects of chlorpheniramine maleate?

Potential side effects include drowsiness, dry mouth, blurred vision, and urinary retention[1].

Why is the Asia-Pacific region expected to grow rapidly in the chlorpheniramine maleate market?

The Asia-Pacific region is expected to grow rapidly due to the rise in prevalence of allergic conditions, an increase in the number of key market players, and growing consumer awareness about allergies, along with factors such as increasing air pollution and a surge in the geriatric population[1].

What are the contraindications for codeine phosphate and chlorpheniramine maleate ER tablets?

These tablets are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy, and in patients with known hypersensitivity to codeine, chlorpheniramine, or any of the inactive ingredients[2].

How do lifestyle changes impact the demand for chlorpheniramine maleate and codeine phosphate combination products?

Lifestyle changes, including unhealthy and sedentary lifestyles, and increasing urbanization, contribute to a higher prevalence of allergic conditions, thereby increasing the demand for these medications[1].

Sources

1. Allied Market Research: Chlorpheniramine Maleate Market Statistics and Forecast - 2032.
2. FDA: CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ER TABLETS.
3. FDA: Codeine phosphate and chlorpheniramine maleate ER tablets.
4. FDA: Tris Pharma, Inc. submitted this 505(b)(2) new drug application for codeine polistirex and chlorpheniramine polistirex extended-release (COD-CPM ER) oral suspension.