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Last Updated: January 1, 2025

PENNTUSS Drug Patent Profile


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When do Penntuss patents expire, and when can generic versions of Penntuss launch?

Penntuss is a drug marketed by Fisons and is included in one NDA.

The generic ingredient in PENNTUSS is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

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Summary for PENNTUSS
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PENNTUSS at DailyMed
Drug patent expirations by year for PENNTUSS

US Patents and Regulatory Information for PENNTUSS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fisons PENNTUSS chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 018928-001 Aug 14, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PENNTUSS Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Prescription Drugs: A Case Study on PENNTUSS and Broader Industry Trends

Introduction

The pharmaceutical industry is a complex and dynamic market influenced by various factors, including patent laws, generic competition, managed care practices, and technological advancements. This article will delve into the market dynamics and financial trajectory of prescription drugs, using PENNTUSS as a case study, and explore broader industry trends that shape the pharmaceutical landscape.

Patent Exclusivity and Generic Competition

When a brand-name drug like PENNTUSS is first introduced, it enjoys a period of patent exclusivity that protects it from generic competition. However, once the patent expires, generic versions can enter the market, significantly altering the financial trajectory of the brand-name drug.

Impact of Generic Entry

The Hatch-Waxman Act has facilitated faster generic entry by providing a streamlined process for generic drug approval. This has led to a quicker erosion of market share for brand-name drugs. For instance, the Congressional Budget Office (CBO) found that the average returns from marketing a new drug decreased by roughly 12% due to increased generic competition[1].

Market Share Erosion

Studies have shown that within a year of generic entry, brand-name drugs can lose a significant portion of their market share. For example, brand-name drugs with sales greater than $250 million before generic entry saw their average unit share drop to 18% one year after generic entry[4].

Managed Care and Prescription Drug Utilization

Managed care practices play a crucial role in shaping the demand for prescription drugs. These practices can influence the frequency and type of prescriptions, thereby affecting the financial performance of both brand-name and generic drugs.

Influence on Brand-Name Drugs

Managed care plans often promote generic substitution, which can drastically reduce the market share of brand-name drugs after their patents expire. This substitution has been a key factor in lowering the profits of brand-name drugs[1].

Impact on Generic Drugs

While generic drugs benefit from managed care's preference for cost-effective options, the profitability of generics has diminished over time. Retail pharmacies have seen significant decreases in profitability due to government price caps and fewer new generics entering the market[2].

Pricing Trends and Financial Implications

The pricing of prescription drugs is a critical factor in their financial trajectory. Recent trends indicate a significant increase in drug prices, which has financial implications for both manufacturers and consumers.

Rising Prices of New Drugs

New drugs are being introduced at record-high prices. For example, the median annual price for new drugs in 2023 was $300,000, a 35% increase from the prior year[5].

Price Increases for Existing Drugs

Prices for existing drugs are also rising faster than general inflation. Between 2022 and 2023, prices for nearly 2,000 drugs increased by an average of 15.2%, significantly outpacing general inflation[5].

Distribution Channels and Business Models

The distribution channels and business models in the pharmaceutical industry are evolving, affecting how drugs are marketed, sold, and delivered.

Changing Distribution Channels

New distribution channels and business models are disrupting traditional practices. For instance, pharmacy benefit managers (PBMs) are shifting from rebate-driven models to administrative and service fee-based models, and limiting distribution networks[2].

Specialty and High-Cost Therapies

Specialty and high-cost therapies, such as those in immunology and neurology, are growing in volume but operate differently from traditional drugs. These therapies require careful planning and operational considerations, including direct contracting with manufacturers and complex delivery services[2].

Financial Metrics and Market Exclusivity

The financial metrics of brand-name drugs are closely tied to their market exclusivity periods and the timing of generic entry.

Market Exclusivity Periods (MEPs)

The average market exclusivity period for new molecular entities (NMEs) has remained relatively stable over the past decade. For NMEs with sales greater than $250 million, the average MEP is around 13 years[4].

Paragraph IV Challenges

Brand-name drugs often face Paragraph IV challenges, which can occur early in the drug's lifecycle. These challenges can lead to earlier generic entry and higher generic penetration rates[4].

Impact on Prescription Drug Spending

The growth in prescription drug spending is driven by several factors, including new drug approvals, price increases, and changes in utilization.

Forecasted Spending Growth

Forecasts indicate that prescription drug spending will continue to increase, with annual growth rates ranging from 10% to 20% over the next several years. New drugs in the pipeline are expected to account for a significant portion of this spending growth[3].

Category-Specific Spending

Certain categories, such as central nervous system drugs and cardiovascular drugs, are projected to account for a substantial portion of the spending increases. For example, central nervous system drugs are expected to account for 24-29% of spending increases[3].

Key Takeaways

  • Generic Competition: The entry of generic drugs significantly erodes the market share and profits of brand-name drugs.
  • Managed Care: Managed care practices influence prescription drug utilization and favor generic substitution, impacting the financial performance of both brand-name and generic drugs.
  • Pricing Trends: New and existing drugs are experiencing significant price increases, affecting the financial trajectory of pharmaceutical companies.
  • Distribution Channels: Evolving distribution channels and business models are changing how drugs are marketed and delivered.
  • Financial Metrics: Market exclusivity periods and the timing of generic entry are critical in determining the financial metrics of brand-name drugs.
  • Spending Growth: Prescription drug spending is expected to continue growing, driven by new drug approvals, price increases, and changes in utilization.

FAQs

Q: How does the Hatch-Waxman Act impact the pharmaceutical industry?

The Hatch-Waxman Act facilitates faster generic entry by providing a streamlined process for generic drug approval, which increases competition and reduces the market share and profits of brand-name drugs.

Q: What role do managed care practices play in the pharmaceutical market?

Managed care practices promote generic substitution, which reduces the market share of brand-name drugs after their patents expire and influences the overall demand for prescription drugs.

Q: Why are new drugs being introduced at record-high prices?

New drugs are often introduced at high prices due to the high costs of research and development, the need to recoup investment before patent expiration, and the willingness of payers to cover these costs for innovative treatments.

Q: How are distribution channels changing in the pharmaceutical industry?

Distribution channels are evolving with new business models, such as PBMs shifting from rebate-driven models to administrative and service fee-based models, and the use of limited distribution networks.

Q: What factors contribute to the growth in prescription drug spending?

The growth in prescription drug spending is driven by new drug approvals, price increases for existing drugs, and changes in utilization patterns, particularly in categories like central nervous system and cardiovascular drugs.

Sources

  1. Congressional Budget Office. "How Increased Competition from Generic Drugs Has Affected Prices and Returns." July 1998.
  2. American Society of Health-System Pharmacists. "Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs." May 2024.
  3. Assistant Secretary for Planning and Evaluation. "Explaining the Growth in Prescription Drug Spending: A Review of Recent Studies."
  4. PubMed. "Continuing trends in U.S. brand-name and generic drug competition."
  5. American Hospital Association. "Drug Prices and Shortages Jeopardize Patient Access to Quality Hospital Care." May 2024.

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