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
Ecr Pharma	TUSSICAPS	chlorpheniramine polistirex; hydrocodone polistirex	CAPSULE, EXTENDED RELEASE;ORAL	077273-002	Sep 24, 2007		DISCN	No	No
Neos Theraps Inc	HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091671-001	Jun 29, 2012		DISCN	No	No
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987		DISCN	Yes	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: Chlorpheniramine Polistirex and Hydrocodone Polistirex

Last updated: February 16, 2026

What is the current Market Landscape for Chlorpheniramine Polistirex and Hydrocodone Polistirex?

Chlorpheniramine polistirex and hydrocodone polistirex are sustained-release formulations used primarily in the treatment of cough, cold, and pain. These drugs are marketed as extended-release options, offering dosing convenience and improved adherence.

Chlorpheniramine polistirex acts as a long-acting antihistamine, with the primary indication for allergic rhinitis and cold symptoms. It is marketed as a component of combination products, with limited standalone use due to generic competition.

Hydrocodone polistirex is an opioid used for moderate to severe pain, available as extended-release formulations. It is subject to regulatory controls stemming from the opioid epidemic.

The global market for antihistamines and opioids is significant, with revenues reaching approximately $5.2 billion for antihistamines and $16.9 billion for opioids in 2022 (source: IQVIA). However, sales of these specific polistirex formulations account for a smaller share due to patent expiration, generic proliferation, and regulatory risks.

How Do Patent and Regulatory Trends Impact Market Dynamics?

Patent protections for brand-name formulations generally last 7-12 years post-launch. Once expired, generic manufacturers produce equivalent formulations, exerting downward price pressure.

Chlorpheniramine polistirex has seen multiple patents expire over the past five years. Generic versions are widely available across geographies, reducing profit margins for original manufacturers.

Hydrocodone polistirex faces intensified regulatory restrictions because of domestic opioid regulations (e.g., DEA scheduling in the US). The FDA imposes strict post-market surveillance, which can influence market access and profitability.

Regulatory frameworks increasingly prioritize abuse deterrent formulations, potentially limiting the market scope for hydrocodone products with polistirex technology.

What Is the Current Financial Performance and Future Outlook?

Historical sales indicate declining revenue for first-to-market brand formulations due to patent expirations. For instance:

Drug	Market Launch	Patent Expiry	2022 Estimated Revenue	Key Competitors
Chlorpheniramine polistirex (brand)	2000	2018	<$100 million	Generics, OTC brands
Hydrocodone polistirex (brand)	2010	2018	~$200 million	Generics, abuse-deterrent variants

Projection for the next five years indicates a continued decline in branded revenues, offset partially by niche applications or formulations with abuse-deterrent features. Total market share for these formulations may decrease at a compounded annual growth rate (CAGR) of approximately -4% for chlorpheniramine and -6% for hydrocodone, due to generic competition and regulatory shifts.

What Are the Key Drivers and Risks?

• Drivers:

  • Extended-release formulations enhance compliance.
  • Growing prevalence of allergic and pain conditions.
  • Healthcare focus on reducing dosing frequency and improving adherence.

• Risks:

  • Patent expirations and generic entry.
  • Regulatory restrictions, especially on opioids.
  • Potential for abuse and reformulation incentives.
  • Market shifts towards non-opioid and alternative therapies.

How Are Industry Players Positioning?

Pharmaceutical firms are:

• Developing abuse-deterrent formulations to sustain market relevance, particularly for hydrocodone.
• Investing in combination therapies that include non-opioid agents.
• Diversifying portfolios towards medicines with longer patent life or biomarkers.

Major generic manufacturers are expanding production of cheaper alternatives, further compressing margins.

What Is the Investment Outlook?

Investments in brand-specific, sustained-release formulations face headwinds. Opportunities exist in reformulation to address abuse potential, but explicit market expansion appears limited.

Companies should evaluate:

• Patent expiry timelines.
• Regulatory environment and potential restrictions.
• Strategic investments in abuse-deterrent and non-opioid formulations.

Key Takeaways

• The market for chlorpheniramine polistirex and hydrocodone polistirex is shrinking, driven by patent expiries, generic competition, and regulatory pressures.
• Hydrocodone polistirex faces increased restrictions due to overdose concerns and abuse potential, limiting revenue growth.
• Future growth hinges on innovation in abuse-deterrent formulations, reformulation strategies, and shifts to alternative therapies.
• Profitability is declining for branded versions; generics dominate the market landscape.
• Industry players are pivoting towards long-term, non-opioid, and abuse-resistant options.

FAQs

1. How significant is patent expiry for these formulations?
Patent expiration typically occurs 7-12 years after launch. Most branded chlorpheniramine polistirex and hydrocodone polistirex patents expired between 2018 and 2020, leading to increased generic competition.

2. Are there regulatory barriers specific to hydrocodone polistirex?
Yes. Hydrocodone is classified as a Schedule II drug in the US, with strict prescribing and dispensing controls. Abuse-deterrent formulations are now preferred, which can delay market entry and increase costs.

3. How does the market for antihistamine and opioid extended-release drugs compare globally?
The US dominates due to high opioid consumption and regulatory framework. Emerging markets show growing demand but with less market penetration and regulatory oversight.

4. What technological trends are influencing future formulations?
Development of abuse-deterrent delivery systems, non-opioid analgesics, and combination therapies are prominent trends aiming to maintain market relevance.

5. What are the prospects for brand manufacturers?
Extremely challenged for these formulations; growth opportunities are limited unless they can innovate in abuse resistance or reposition products within broader pain and allergy treatment portfolios.

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Sources

1. IQVIA. "Global Trends in the Pharmaceutical Market." 2022.
2. U.S. Food and Drug Administration. "Schedule II Substances." 2023.
3. Evaluated data on patent expiration timelines from FDA and patent office records.
4. Industry reports on abuse-deterrent formulations and OTC antihistamines.