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.

Three 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:	3
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	077273-001	Sep 24, 2007		DISCN	No	No
Tris Pharma Inc	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091632-001	Oct 1, 2010		RX	No	Yes
Ecr Pharma	TUSSICAPS	chlorpheniramine polistirex; hydrocodone polistirex	CAPSULE, EXTENDED RELEASE;ORAL	077273-002	Sep 24, 2007		DISCN	No	No
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987		DISCN	Yes	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

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

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorpheniramine Polistirex and Hydrocodone Polistirex

Introduction

Chlorpheniramine polistirex and hydrocodone polistirex, a combination of an antihistamine and an opioid agonist, are used for the temporary relief of cough and upper respiratory symptoms associated with allergies or the common cold. This article delves into the market dynamics and financial trajectory of this drug, highlighting key aspects such as market demand, competition, regulatory approvals, and financial projections.

Market Demand

The demand for chlorpheniramine polistirex and hydrocodone polistirex is driven by the prevalence of respiratory conditions, particularly during cough and cold seasons. Antitussives, such as this combination drug, are among the most commonly prescribed medications during these periods. According to historical data, net sales for Tussionex and related generics were $127 million in 2011, indicating a significant market[1].

Regulatory Approvals

The FDA approval of generic versions of this drug has been a crucial factor in its market dynamics. For instance, Cornerstone Therapeutics Inc. received FDA approval for its ANDA (Abbreviated New Drug Application) for a generic hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension. This approval allows Cornerstone to market the product through its subsidiary, Aristos Pharmaceuticals, Inc., which is expected to capitalize on the existing demand for such medications[1].

Competition

The market for chlorpheniramine polistirex and hydrocodone polistirex is competitive, with multiple generic versions available. Despite this competition, companies like Cornerstone Therapeutics anticipate strong market opportunities due to the high demand for these medications. The use of proprietary technologies, such as NEOS Therapeutics' Dynamic Time Release Suspension (DTRS), can provide a competitive edge in terms of product formulation and delivery[1].

Financial Projections

The financial trajectory of this drug is influenced by several factors, including market demand, competition, and regulatory environments. With the FDA approval of generic versions, companies can expect significant revenue from these products. For example, Cornerstone Therapeutics plans to leverage its existing relationships in the respiratory field and distribution expertise to gain market share. The company's ability to supply product to meet increased demand is expected to drive revenue growth[1].

Pricing and Revenue

The pricing of chlorpheniramine polistirex and hydrocodone polistirex can vary based on the brand, generic status, and regional market conditions. Generic versions typically offer a more affordable alternative to branded products, which can increase market penetration and revenue. Historical data indicates that the market for such antitussives can generate substantial revenue, with net sales of $127 million for related generics in 2011[1].

Distribution and Marketing

Effective distribution and marketing strategies are crucial for capturing market share. Companies like Cornerstone Therapeutics intend to utilize their existing distribution networks and relationships within the respiratory field to promote their generic product. This approach can help in quickly gaining traction in the market and maximizing revenue potential[1].

Safety and Regulatory Considerations

The financial trajectory of chlorpheniramine polistirex and hydrocodone polistirex is also influenced by safety and regulatory considerations. The drug is a Schedule III narcotic, and its use is associated with risks such as addiction, abuse, and life-threatening respiratory depression. These risks necessitate careful prescribing and monitoring, which can impact market dynamics and financial performance. Regulatory compliance and adherence to safety guidelines are essential for maintaining market approval and avoiding financial penalties[5].

Bioequivalence and Quality Control

Ensuring bioequivalence to the reference listed drug is a critical aspect of generic drug development. The FDA requires rigorous testing, including dissolution testing, to ensure that generic versions are therapeutically equivalent to the branded product. Compliance with these regulations is vital for maintaining market approval and consumer trust, which in turn affects the financial performance of the drug[4].

Clinical Studies and Bioavailability

Clinical studies, such as the one evaluating the oral bioavailability of the Mallinckrodt extended release test capsule formulation, provide valuable data on the drug's performance. These studies help in understanding the drug's pharmacokinetics, which is essential for ensuring its safety and efficacy. Positive outcomes from such studies can enhance market confidence and contribute to the drug's financial success[3].

Patient Safety and Adverse Reactions

Patient safety is a paramount concern for any pharmaceutical product. Chlorpheniramine polistirex and hydrocodone polistirex can cause adverse reactions such as respiratory depression, especially in pediatric patients and those with certain medical conditions. Managing these risks through proper prescribing practices and patient monitoring is crucial for maintaining a positive market image and avoiding financial repercussions due to safety issues[2][5].

Market Expansion and Growth Opportunities

The market for chlorpheniramine polistirex and hydrocodone polistirex offers growth opportunities, particularly in regions with high prevalence of respiratory conditions. Companies can expand their market share by targeting these regions and leveraging their distribution networks. Additionally, innovations in formulation technology, such as NEOS Therapeutics' DTRS, can provide a competitive edge and drive market growth[1].

Conclusion

The market dynamics and financial trajectory of chlorpheniramine polistirex and hydrocodone polistirex are influenced by a combination of factors including market demand, competition, regulatory approvals, and safety considerations. With careful management of these factors, companies can capitalize on the significant market opportunities available for this drug.

Key Takeaways

• High Market Demand: The drug addresses a common need for relief from cough and upper respiratory symptoms.
• Regulatory Approvals: FDA approvals for generic versions have opened up new market opportunities.
• Competitive Market: Multiple generic versions exist, but proprietary technologies can provide a competitive edge.
• Financial Projections: Significant revenue potential due to high demand and effective distribution strategies.
• Safety and Regulatory Considerations: Careful prescribing and monitoring are necessary to manage risks associated with the drug.
• Bioequivalence and Quality Control: Compliance with FDA regulations is crucial for maintaining market approval.
• Clinical Studies: Positive outcomes from clinical studies enhance market confidence and contribute to financial success.

Frequently Asked Questions (FAQs)

Q: What is the primary use of chlorpheniramine polistirex and hydrocodone polistirex? A: The primary use is for the temporary relief of cough and upper respiratory symptoms associated with allergies or the common cold.

Q: Who is the target patient population for this drug? A: The drug is indicated for adults 18 years of age and older, and children 6 years of age and older, for the relief of cough and upper respiratory symptoms.

Q: What are the key safety concerns associated with this drug? A: The drug is associated with risks such as addiction, abuse, life-threatening respiratory depression, and other adverse reactions, particularly in pediatric patients and those with certain medical conditions.

Q: How does the FDA approval of generic versions impact the market? A: FDA approval of generic versions increases market competition, providing more affordable alternatives and potentially increasing market penetration and revenue.

Q: What role do proprietary technologies play in the market dynamics of this drug? A: Proprietary technologies, such as NEOS Therapeutics' Dynamic Time Release Suspension (DTRS), can provide a competitive edge in terms of product formulation and delivery, helping companies to differentiate their products in a competitive market.

Cited Sources

1. FDA Approves Cornerstone Therapeutics' ANDA - Cornerstone Therapeutics Inc.
2. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended ... - DailyMed
3. Fed Study of Chlorpheniramine Polistirex and Hydrocodone ... - Veeva Systems
4. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended- release Oral Suspension - FDA
5. Hydrocodone Polistirex and Chlorpheniramine Polistirex Suspension - Drugs.com