CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX - Generic Drug Details

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

Chlorpheniramine polistirex; codeine polistirex is the generic ingredient in three branded drugs marketed by Lannett Co Inc, Fisons, and Tris Pharma Inc, and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Chlorpheniramine polistirex; codeine polistirex has twenty-one patent family members in fourteen countries.

Summary for CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

International Patents:	21
US Patents:	2
Tradenames:	3
Applicants:	3
NDAs:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX
DailyMed Link:	CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX at DailyMed

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

Dosage:

SUSPENSION, 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.

Anatomical Therapeutic Chemical (ATC) Classes for CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

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 POLISTIREX; CODEINE POLISTIREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	TUZISTRA XR	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	207768-001	Apr 30, 2015		DISCN	Yes	No			Y
Lannett Co Inc	CODEPREX	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	021369-001	Jun 21, 2004		DISCN	No	No
Tris Pharma Inc	TUZISTRA XR	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	207768-001	Apr 30, 2015		DISCN	Yes	No			Y
Fisons	PENNTUSS	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	018928-001	Aug 14, 1985		DISCN	No	No

Expired US Patents for CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fisons	PENNTUSS	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	018928-001	Aug 14, 1985

International Patents for CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Denmark	2428205
Brazil	PI0709606	formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Denmark	2018160
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorpheniramine Polistirex; Codeine Polistirex

Introduction

Chlorpheniramine polistirex and codeine polistirex, a combination drug, is widely used for the treatment of cough and respiratory symptoms associated with colds or allergies. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this drug.

Market Size and Growth

The global cough suppressant drugs market, which includes chlorpheniramine polistirex and codeine polistirex, was valued at US$ 1100.4 million in 2017 and is expected to grow at a CAGR of 3.7% from 2018 to 2026[1].

Regional Dominance

North America is anticipated to hold a dominant position in the market due to frequent approvals of new cough suppressant drugs by the FDA. For instance, the approval of Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) in 2015 by the FDA marked a significant milestone in this region[1][2].

Product Launches and Approvals

The launch of Tuzistra XR, an extended-release oral suspension, has been a key driver in the market. This product, developed using Tris Pharma’s liquid sustained release technology (LiquiXR), allows for 12-hour dosing, which is a significant improvement over traditional short-acting treatments that require dosing 4-6 times a day[2].

Market Drivers

• High Prevalence of Cough: Cough is one of the most common reasons for visits to primary care physicians globally, accounting for around 8% of all consultations. The annual prevalence of cough in the general population is approximately 10–33% globally, driving the demand for cough suppressant drugs[1].
• Aging Population: The increasing aging population, particularly in regions like North America and Asia-Pacific, contributes to higher demand for pain and cough management drugs, including codeine formulations[4].
• Strategic Partnerships: Key players are involved in strategic mergers and partnerships to develop, manufacture, and sell novel cough suppressant drugs. For example, Tris Pharma’s agreement with Pfizer Consumer Healthcare to commercialize extended-release dextromethorphan cough syrup under the Robitussin brand has been instrumental in market growth[1].

Market Restraints

• Stringent Regulations: Stringent regulations against the use of codeine-containing drugs are a significant restraint. For instance, the reclassification of codeine as a prescription-only medicine in Australia in 2018, due to its potential for addiction, has impacted market growth[1][4].
• Safety Concerns: Codeine polistirex and chlorpheniramine polistirex combination carries risks of addiction, abuse, and misuse, which can lead to overdose and death. This necessitates careful patient monitoring and has regulatory implications[5].

Distribution and Sales

The US cough cold prescription market, where Tuzistra XR is a key player, is worth over $3 billion with 30-35 million annual prescriptions. The distribution of these drugs is primarily through pharmacies and healthcare providers, with dedicated sales teams promoting the products to physicians[2].

Financial Performance

The financial trajectory of chlorpheniramine polistirex and codeine polistirex is closely tied to the overall cough suppressant drugs market. With a projected CAGR of 3.7%, the market is expected to see steady growth. The launch of new products like Tuzistra XR and strategic partnerships contribute significantly to the financial performance of key players in this market.

Revenue Streams

• Prescription Sales: The primary revenue stream comes from prescription sales, with Tuzistra XR being a notable example. Its unique 12-hour dosing regimen has attracted significant market share in the US cough cold prescription market[2].
• Licensing Agreements: Companies like Tris Pharma and Vernalis plc generate revenue through licensing agreements. For instance, Tris Pharma’s agreement with Pfizer Consumer Healthcare includes upfront payments, milestone payments, and sales-based royalties[1].

Competitive Landscape

Key players in the market include Tris Pharma, Inc., Vernalis plc, Pfizer Consumer Healthcare, and Aytu BioScience, Inc. These companies are actively involved in developing and commercializing new cough suppressant drugs, including chlorpheniramine polistirex and codeine polistirex combinations.

Market Share Analysis

The global cough suppressant drugs market share is segmented by region, with North America holding a dominant position. The market share analysis also highlights the distribution channels, with pharmacies and healthcare providers being the primary outlets[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of chlorpheniramine polistirex and codeine polistirex. Regulatory bodies like the FDA and the Therapeutic Goods Administration in Australia have implemented stringent regulations to control the use of codeine-containing drugs due to their potential for addiction and abuse[1][4].

Monitoring and Compliance

Regulatory measures include electronic monitoring of prescription drug claims to identify issues such as therapeutic duplication and drug-disease contraindications. States in the US have implemented system-accumulation edits to prevent early prescription refills, further tightening the regulatory grip[3].

Future Outlook

Despite the restraints posed by stringent regulations, the market for chlorpheniramine polistirex and codeine polistirex is expected to grow driven by high demand for cough suppressant drugs and the introduction of new products with improved dosing regimens.

Emerging Trends

• Extended-Release Formulations: The development of extended-release formulations like Tuzistra XR is expected to continue, offering patients more convenient and effective treatment options.
• Strategic Collaborations: Increased collaboration between pharmaceutical companies to develop and commercialize new products will be a key trend in the future.

Key Takeaways

• The global cough suppressant drugs market, including chlorpheniramine polistirex and codeine polistirex, is expected to grow at a CAGR of 3.7% from 2018 to 2026.
• North America dominates the market due to frequent FDA approvals of new drugs.
• High prevalence of cough and strategic partnerships drive market growth.
• Stringent regulations and safety concerns are significant restraints.
• Extended-release formulations and strategic collaborations are emerging trends.

FAQs

What is the primary use of chlorpheniramine polistirex and codeine polistirex?

Chlorpheniramine polistirex and codeine polistirex is used to treat cough and respiratory symptoms associated with colds or allergies.

Which region dominates the market for cough suppressant drugs?

North America dominates the market for cough suppressant drugs, including chlorpheniramine polistirex and codeine polistirex, due to frequent FDA approvals of new drugs.

What is the significance of Tuzistra XR in the market?

Tuzistra XR is the only codeine-based extended-release cough cold syrup available in the US, offering a 12-hour dosing regimen, which is a significant improvement over traditional short-acting treatments.

What are the major restraints in the market for chlorpheniramine polistirex and codeine polistirex?

Stringent regulations against the use of codeine-containing drugs and safety concerns related to addiction and abuse are major restraints in the market.

How do regulatory bodies monitor the use of codeine-containing drugs?

Regulatory bodies use electronic monitoring of prescription drug claims and system-accumulation edits to prevent early prescription refills and ensure compliance with safety guidelines.

Sources

1. Coherent Market Insights - Cough Suppressant Drugs Market - Price, Size, Share & Growth
2. Tris Pharma - Vernalis PLC launches Tuzistra™ XR (codeine polistirex and chlorpheniramine polistirex) for cough relief with 12-hour dosing
3. Medicaid.gov - National Medicaid Fee-For-Service (FFS) FFY 2022 Drug Utilization Report
4. Coherent Market Insights - Codeine Market - Companies, Size, Share & Research Analysis
5. Drugs.com - Chlorpheniramine and codeine polistirex (Oral) - Uses, Side Effects, Interactions, Pictures, Warnings & Dosing