Chlorpheniramine polistirex; hydrocodone polistirex - Generic Drug Details

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

Chlorpheniramine polistirex; hydrocodone polistirex is the generic ingredient in four branded drugs marketed by Ecr Pharma, Tris Pharma Inc, Neos Theraps Inc, and Ucb Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for chlorpheniramine polistirex; hydrocodone polistirex

US Patents:	0
Tradenames:	4
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
DailyMed Link:	chlorpheniramine polistirex; hydrocodone polistirex at DailyMed

Recent Clinical Trials for chlorpheniramine polistirex; hydrocodone polistirex

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mallinckrodt	Phase 1

See all chlorpheniramine polistirex; hydrocodone polistirex clinical trials

Pharmacology for chlorpheniramine polistirex; hydrocodone polistirex

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

Anatomical Therapeutic Chemical (ATC) Classes for chlorpheniramine polistirex; hydrocodone 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

Paragraph IV (Patent) Challenges for CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TUSSIONEX PENNKINETIC	Extended-release Capsules	chlorpheniramine polistirex; hydrocodone polistirex	8 mg/10 mg and 4 mg/5 mg	019111	1	2004-09-10

US Patents and Regulatory Information for chlorpheniramine polistirex; hydrocodone 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	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091632-001	Oct 1, 2010		RX	No	Yes
Neos Theraps Inc	HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091671-001	Jun 29, 2012		DISCN	No	No
Ecr Pharma	TUSSICAPS	chlorpheniramine polistirex; hydrocodone polistirex	CAPSULE, EXTENDED RELEASE;ORAL	077273-001	Sep 24, 2007		DISCN	No	No

Expired US Patents for chlorpheniramine polistirex; hydrocodone polistirex

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987

Market Dynamics and Financial Trajectory for Chlorpheniramine Polistirex and Hydrocodone Polistirex

Last updated: July 30, 2025

Introduction

Chlorpheniramine polistirex and hydrocodone polistirex are extended-release pharmaceutical formulations used primarily for cough, cold, allergy relief, and pain management. As combination products employing unique polymer-based delivery systems—polistirex—a thorough understanding of their market environment and financial prospects is essential for stakeholders, including manufacturers, investors, healthcare providers, and regulatory bodies. This analysis explores current market dynamics, regulatory landscape, technological trends, and the financial trajectory anticipated for these drugs.

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Market Overview

Chlorpheniramine Polistirex

Chlorpheniramine, an antihistamine, when formulated as chlorpheniramine polistirex, provides extended relief from allergic symptoms and cold-associated rhinorrhea. Its proprietary polymer matrix prolongs drug release, allowing once-daily dosing, which enhances patient compliance. The drug is commonly marketed under brands like Chlor-Trimeton Expectorant in combination with dextromethorphan compounds.

Market Size & Growth Factors:
The global antihistamine market is projected to grow at a CAGR of approximately 5% through 2028, driven by increasing allergy prevalence, especially in developed nations. Extended-release formulations, such as chlorpheniramine polistirex, are increasingly favored for their efficacy and convenience [1].

Competitive Position:
The market faces competition from other antihistamines (e.g., loratadine, cetirizine) and alternative delivery systems. However, the unique extended-release polistirex formulation offers differentiation, retaining a niche, especially in formulations targeting rapid symptom control with favorable pharmacokinetics.

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Hydrocodone Polistirex

Hydrocodone polistirex functions as an opioid analgesic with extended-release properties, primarily used for moderate to severe pain management. It is delivered via polymer-based matrix to provide sustained serum levels, reducing dosing frequency and improving adherence.

Market Size & Trends:
The opioid analgesics market remains substantial, with global revenues exceeding $7 billion in 2022 and expected growth attributable to aging populations and increasing prevalence of chronic pain conditions [2]. However, the market's trajectory is subject to significant regulatory scrutiny owing to abuse potential.

Patient and Prescriber Preferences:
Extended-release hydrocodone formulations like hydrocodone polistirex are preferred in chronic pain contexts, but their growth is tempered by concerns over opioid misuse, regulatory controls, and shifting prescribing guidelines emphasizing non-opioid alternatives.

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Market Dynamics and External Drivers

Regulatory Environment

The landscape is shaped by intense regulatory oversight. Post-2010 opioid epidemic revelations prompted agencies like the FDA and DEA to impose tighter restrictions on hydrocodone products. Notably, hydrocodone formulations transitioned from Schedule III to Schedule II in the U.S. in 2014, reflecting increased risk awareness [3].

Implication:
Such regulations create barriers to market entry, impact formulations’ availability, and influence pricing. For chlorpheniramine polistirex, approval pathways are comparatively streamlined, but quality standards for extended-release formulations remain strict.

Patent and Exclusivity Challenges

Compound patents for these drugs have generally expired, leading to increased generic competition. However, formulation patents related to the polymer matrix can sustain exclusivity periods. Extending patent life via secondary patents on delivery technology offers a strategic advantage.

Implication:
Market entry barriers are lowered for generics but strategic patent protections specific to the polistirex delivery system can sustain revenue streams.

Technological Trends

Innovation centers on enhancing drug release profiles, reducing abuse potential (particularly for opioids), and improving safety. Abuse-deterrent formulations (ADFs) incorporating polymer matrices like polistirex are gaining interest but face regulatory scrutiny regarding their effectiveness.

Future Prospects:
Research into novel delivery systems including biodegradable polymers, nanotechnology, and digital adherence solutions is ongoing, promising improved therapeutic profiles and market differentiation.

Healthcare System and Prescriber Behavior

The shift towards multimodal pain management, opioid stewardship programs, and emphasis on non-opioid alternatives depress the growth potential for hydrocodone-based formulations. Conversely, demand for rapid relief in allergy and cold symptoms supports chlorpheniramine polistirex product stability.

Patient Preferences:
Convenience, compliance, and safety concerns influence prescription trends, favoring extended-release formulations that reduce dosing frequency.

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Financial Trajectory and Market Forecasts

Revenue Projections

• Chlorpheniramine Polistirex:
  Projected to maintain a modest CAGR of 3-4% over the next five years, driven by steady demand in allergy and cold markets, especially in emerging markets with rising smartphone-based healthcare awareness and OTC medication utilization. Patent protection for certain formulations can provide a revenue cushion.

• Hydrocodone Polistirex:
  Forecasted to experience negligible or slight decline (-1% to 0%) due to regulatory pressure, increased generic competition, and shifts towards alternative therapies. While the overall opioid market remains large, growth is constrained.

Profitability Outlook

Profit margins for chlorpheniramine polistirex formulations remain relatively stable, supported by low manufacturing costs and moderate brand premiums. Hydrocodone polistirex margins are under pressure due to regulatory compliance costs, liability concerns, and pricing pressures from generics.

Emerging Opportunities

• Development of abuse-deterrent formulations integrating polistirex may command premium pricing.
• Entry into developing markets offers upside, leveraging lower regulatory hurdles.
• Diversification into combination products for chronic cough and pain management.

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Challenges and Risks

1. Regulatory Restrictions:
   Decreased allowable prescribing of opioids curtails hydrocodone polistirex markets. Similarly, stringent regulations impact manufacturing capabilities.

2. Market Saturation:
   Patent expiries and generic competition threaten profit margins, especially for hydrocodone formulations.

3. Public Perception and Abuse Potential:
   Negative perceptions surrounding opioids and safety concerns influence prescribing trends and reimbursement policies.

4. Innovation Risks:
   Failure to develop superior formulations or compliance with evolving standards hampers growth.

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Strategic Implications

Stakeholders should prioritize investment in alternative delivery systems, optimize existing formulations through secondary patents, and explore synthetic or plant-based production pathways to mitigate cost pressures. Regulatory engagement for abuse-deterrent technologies offers avenues for differentiation and premium pricing.

Furthermore, aligning product development with emerging healthcare trends—such as digital health integration, personalized medicine, and minimally invasive therapy—will enhance market resilience.

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Key Takeaways

• Chlorpheniramine polistirex is positioned for steady growth driven by demand for extended-release allergy medications; patent protections and OTC availability sustain revenue streams, but innovation is essential to remain competitive.
• Hydrocodone polistirex faces headwinds from regulatory restrictions, abuse concerns, and market saturation; growth prospects depend on reformulation, abuse-deterrent technologies, and market diversification.
• Regulatory policies significantly influence market dynamics, particularly for opioids, necessitating proactive engagement and compliance strategies.
• Technological advancements in delivery systems offer opportunities for differentiation and premium pricing, especially through abuse-deterrent formulations.
• Future market growth hinges on balancing innovation with regulatory and societal pressures, emphasizing safety, efficacy, and patient compliance.

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FAQs

1. How does the extended-release formulation of chlorpheniramine polistirex improve patient outcomes?
It provides sustained symptom relief with once-daily dosing, enhancing compliance and reducing the risk of missed doses, especially in chronic allergy sufferers.

2. What regulatory challenges does hydrocodone polistirex face?
It faces strict controls due to abuse potential, including classification as a Schedule II substance, requiring rigorous manufacturing, dispensing, and monitoring protocols.

3. Are there any innovative technologies being developed for abuse deterrence in hydrocodone formulations?
Yes, formulations incorporating polymer matrices like polistirex are being enhanced with abuse-deterrent features such as impairing crushing or injection, though efficacy varies.

4. What role do patents play in the market longevity of these formulations?
Patents on drug composition and delivery systems extend exclusivity, delaying generic competition and protecting revenue streams for manufacturers.

5. How might market trends shift in the coming decade for these drugs?
Anticipated trends include increased regulatory scrutiny on opioids, rising demand for safe, extended-release allergy medications, and technological innovations driving newer formulations.

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References

[1] MarketWatch, “Global Antihistamines Market,” 2021.

[2] Grand View Research, “Pain Management Market Size, Share & Trends,” 2022.

[3] FDA, “Reclassification of Hydrocodone Combination Products,” 2014.