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Last Updated: December 22, 2024

OPIPZA Drug Patent Profile


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

Opipza is a drug marketed by Xiamen Lp Pharm Co and is included in one NDA.

The generic ingredient in OPIPZA is aripiprazole. There are forty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Opipza

A generic version of OPIPZA was approved as aripiprazole by ALEMBIC on April 28th, 2015.

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Summary for OPIPZA
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in OPIPZA?OPIPZA excipients list
DailyMed Link:OPIPZA at DailyMed
Drug patent expirations by year for OPIPZA
Pharmacology for OPIPZA

US Patents and Regulatory Information for OPIPZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xiamen Lp Pharm Co OPIPZA aripiprazole FILM;ORAL 216655-001 Jul 22, 2024 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiamen Lp Pharm Co OPIPZA aripiprazole FILM;ORAL 216655-002 Jul 22, 2024 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiamen Lp Pharm Co OPIPZA aripiprazole FILM;ORAL 216655-003 Jul 22, 2024 RX Yes Yes ⤷  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

OPIPZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Understanding the Complexities

Introduction

When analyzing the market dynamics and financial trajectory of a drug, whether it is a newly developed pharmaceutical like OPIPZA or an existing medication, several key factors come into play. These include the drug's development process, pricing strategies, market competition, and the broader economic and regulatory environment.

Drug Development Process

The development of a drug like OPIPZA involves significant investment in research and development (R&D). This process is costly and time-consuming, often spanning several years and involving multiple phases of clinical trials[3].

Research and Development Costs

The R&D costs for pharmaceuticals are substantial, with estimates suggesting that the average cost to develop a new drug can exceed $1 billion. This high cost is a major factor in the pricing strategy of pharmaceutical companies, as they need to recoup their investment and generate profits[3].

Clinical Trials and Regulatory Approval

The journey from the lab to the market involves rigorous clinical trials and regulatory approvals. For drugs targeting small patient populations, such as orphan drugs, the process can be particularly challenging due to the limited market size and the need for precise targeting[3].

Pricing Strategies

Pricing is a critical component of a drug's market dynamics. Here are some key considerations:

Precision Medicines and Orphan Drugs

Drugs like OPIPZA, especially if they are precision medicines or orphan drugs, often command high prices due to their targeted nature and the small patient population. For example, drugs like Kalydeco for cystic fibrosis can cost several hundred thousand dollars per year because the patient population is very small, justifying the high price to ensure profitability[3].

Market Competition

The level of competition in the market also influences pricing. For drugs with no generic competition, especially those targeting small patient populations, prices can remain high even after patent expiration. This is because the fixed costs of entry and the likelihood of intense post-entry price competition deter new entrants[3].

Market Dynamics: Demand and Supply

Understanding the demand and supply dynamics is crucial for predicting the financial trajectory of a drug.

Demand Factors

Demand for a drug can be influenced by several factors, including the prevalence of the condition it treats, the effectiveness of the drug, and the availability of alternative treatments. For instance, the rise of synthetic opioids has altered demand patterns in the global drug market, potentially reducing the demand for traditional plant-based opioids in some regions[4].

Supply Chain and Distribution

The supply chain and distribution networks play a significant role in the market dynamics. For example, the rise of synthetic opioids has fragmented the global drug market, with traditional plant-based production countries like Afghanistan and Myanmar primarily supplying neighboring regions rather than global markets[4].

Financial Trajectory

The financial performance of a drug is closely tied to its market dynamics.

Revenue and Profitability

The revenue and profitability of a drug depend on its pricing, market size, and competition. High-priced drugs targeting small patient populations can generate significant revenue and profitability despite the limited market size. For instance, the economic implications of precision medicines include higher prices and significant profits due to the high value created for patients with rare conditions[3].

Example: OppFi's Financial Performance

While not directly related to pharmaceuticals, the financial performance of companies like OppFi can provide insights into how strong market positioning and efficient operations can lead to significant financial outperformance. OppFi's Q3 2024 results, with a 106.4% year-over-year increase in net income and a 116.2% increase in adjusted net income, demonstrate the impact of effective market strategies and operational efficiency on financial performance[2].

Regulatory Environment

The regulatory environment is a critical factor in the market dynamics and financial trajectory of a drug.

Government Incentives and Policies

Government incentives and policies can significantly impact the development and pricing of drugs. For example, incentives for R&D in specific areas, such as precision medicines, can influence the types of drugs that are developed and their pricing strategies[3].

International Relations and Foreign Policy

The global drug market is also influenced by international relations and foreign policy. The rise of synthetic opioids, for instance, has the potential to fragment the global drug market and alter major aspects of international relations and U.S. foreign policy[4].

Consumer Preferences and Behavioral Factors

Consumer preferences and behavioral factors also play a role in the market dynamics of drugs.

Preferences for Plant-Based vs. Synthetic Drugs

Consumer preferences can vary significantly between different regions and user groups. For example, in some regions, users may prefer plant-based drugs over synthetic opioids due to various factors such as availability, cost, and personal preference[4].

Key Takeaways

  • High Development Costs: The development of drugs like OPIPZA involves significant R&D costs, which are reflected in their pricing.
  • Pricing Strategies: Precision medicines and orphan drugs often command high prices due to their targeted nature and small patient populations.
  • Market Competition: The absence of generic competition in small patient markets can maintain high prices even after patent expiration.
  • Demand and Supply Dynamics: Demand can be influenced by prevalence, effectiveness, and availability of alternatives, while supply chains and distribution networks affect market reach.
  • Financial Performance: Revenue and profitability depend on pricing, market size, and competition, with high-priced drugs generating significant revenue despite limited market size.
  • Regulatory Environment: Government incentives and policies, as well as international relations, significantly impact the development and pricing of drugs.
  • Consumer Preferences: Preferences for plant-based vs. synthetic drugs vary by region and user group, influencing market dynamics.

FAQs

What are the main factors influencing the pricing of precision medicines like OPIPZA?

The main factors include the small patient population, high R&D costs, and the high value created for patients with rare conditions.

How does the rise of synthetic opioids affect the global drug market?

The rise of synthetic opioids can fragment the global drug market, alter major aspects of international relations, and change consumer preferences, potentially reducing the demand for traditional plant-based opioids in some regions.

What role do government incentives play in the development of precision medicines?

Government incentives can influence the types of drugs developed and their pricing strategies by providing support for R&D in specific areas.

How does the absence of generic competition affect the pricing of drugs targeting small patient populations?

The absence of generic competition can maintain high prices even after patent expiration due to the fixed costs of entry and the likelihood of intense post-entry price competition deterring new entrants.

What are the implications of consumer preferences for plant-based vs. synthetic drugs on market dynamics?

Consumer preferences can vary significantly, influencing demand patterns and the market reach of different types of drugs, with some users preferring plant-based drugs over synthetic opioids due to various factors.

Sources

  1. Key market data: heroin prices, purities and offences. European Union Agency for the Coordination of Drug and Alcohol Policies.
  2. Q3 Profits Surge 106% to $32.1M, Crushes Analyst Estimates. Stock Titan.
  3. The Economics of Drug Development: Pricing and Innovation in a Changing Market. National Bureau of Economic Research.
  4. How synthetic opioids can radically change global illegal drug markets and foreign policy. Brookings.

More… ↓

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