You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

CHOLEDYL SA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Choledyl Sa, and what generic alternatives are available?

Choledyl Sa is a drug marketed by Warner Chilcott Llc and is included in two NDAs.

The generic ingredient in CHOLEDYL SA is oxtriphylline. There are three drug master file entries for this compound. Additional details are available on the oxtriphylline profile page.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for CHOLEDYL SA?
  • What are the global sales for CHOLEDYL SA?
  • What is Average Wholesale Price for CHOLEDYL SA?
Summary for CHOLEDYL SA
Drug patent expirations by year for CHOLEDYL SA

US Patents and Regulatory Information for CHOLEDYL SA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc CHOLEDYL SA oxtriphylline TABLET, EXTENDED RELEASE;ORAL 087863-001 May 24, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Warner Chilcott Llc CHOLEDYL SA oxtriphylline TABLET, EXTENDED RELEASE;ORAL 086742-001 Approved Prior to Jan 1, 1982 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

CHOLEDYL SA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CHOLEDYL SA

Introduction

CHOLEDYL SA, a medication used to treat gallstones and other bile duct disorders, operates within a complex pharmaceutical market influenced by various factors, including regulatory environments, competition, and economic conditions. This article will delve into the market dynamics and financial trajectory of CHOLEDYL SA, considering broader industry trends and specific market conditions.

Pharmaceutical Market Overview

The global pharmaceutical market has seen significant growth over the past few years, driven by increasing demand for healthcare services and advancements in medical technology. According to recent trends, total inflation-adjusted expenditures on prescription drugs grew from $520 billion in 2016 to $603 billion in 2021, a 16% increase[4].

Generic vs. Brand Name Drugs

CHOLEDYL SA, being a generic or branded drug, faces different market dynamics depending on its classification. Generic drugs have seen a steady decline in retail expenditures but an increase in non-retail settings. In contrast, brand name drugs have experienced a continual increase in total expenditures, largely due to growth in spending per prescription[4].

Specialty Drugs

While CHOLEDYL SA may not be classified as a specialty drug, the trend towards a larger share of new drug approvals for specialty drugs is noteworthy. Specialty drug spending increased by 43% between 2016 and 2021, despite a minimal increase in the number of prescriptions[4].

Regional Market Considerations

Sub-Saharan Africa

In regions like sub-Saharan Africa, the pharmaceutical market is heavily reliant on imports, with up to 90% of drugs being imported. Local production is limited, with only a few countries like Kenya, Nigeria, and South Africa having a sizable industry. This reliance on imports can impact the availability and affordability of drugs like CHOLEDYL SA in these markets[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. In sub-Saharan Africa, countries are investing in strengthening their regulatory capacities to ensure quality and safety standards. For example, Ethiopia has committed to reducing delays in product registration and ferreting out counterfeit drugs, which can positively impact the market for locally produced and imported drugs like CHOLEDYL SA[1].

Financial Trajectory

Cost and Pricing

The financial trajectory of CHOLEDYL SA is influenced by its production costs, pricing strategies, and market demand. Generic versions of the drug, if available, would typically be priced lower than the branded version, affecting revenue. The cost of active pharmaceutical ingredients (APIs) and the formulation process also play significant roles in determining the final price of the drug[1].

Investment and Production Capacity

Investment in production capacity is critical for maintaining a stable financial trajectory. Countries with favorable investment climates, such as South Africa, are more attractive to private-sector pharmaceutical investors. This investment can lead to increased production capacity, reducing reliance on imports and potentially lowering costs for drugs like CHOLEDYL SA[1].

Revenue Streams

The revenue streams for CHOLEDYL SA can be segmented into retail and non-retail settings. Retail sales typically involve direct consumer purchases, while non-retail sales include prescriptions filled through hospitals, clinics, and other healthcare facilities. The trend of increasing spending per prescription, especially in non-retail settings, can positively impact the revenue of drugs like CHOLEDYL SA[4].

Competitive Landscape

Follow-On Drugs

The competitive landscape for CHOLEDYL SA includes the presence of follow-on or 'me-too' drugs. These drugs often provide similar therapeutic options and can inject price competition into the marketplace. The speed of competitive entry has increased over time, with follow-on drugs entering the market more quickly than in the past[3].

Regional Hubs

The concept of regional hubs in pharmaceutical production can also impact the competitive landscape. By creating globally competitive industry clusters, smaller countries can benefit from faster lead times and more responsive supply chains, potentially reducing the market share of drugs like CHOLEDYL SA if they are not part of these hubs[1].

Quality and Regulatory Compliance

Ensuring quality and regulatory compliance is essential for the financial health and market presence of CHOLEDYL SA. A stronger regulatory system allows for a fair and competitive playing field, eliminating substandard products. Continuous funding for regulatory agencies and the cultivation of regulatory talent are crucial for maintaining high standards[1].

Market Projections

Demographic Changes

Demographic changes, such as population growth and age distribution, can impact the demand for drugs like CHOLEDYL SA. In regions with a high proportion of young people, such as sub-Saharan Africa, the projected increase in the population at risk of various health conditions could drive up demand for pharmaceuticals[5].

Economic Factors

Economic factors, including government budgets and foreign exchange limitations, can also influence the market for CHOLEDYL SA. In regions heavily reliant on imports, economic instability can lead to fluctuations in drug availability and pricing[1].

Key Takeaways

  • Market Dependence on Imports: In regions like sub-Saharan Africa, the heavy reliance on imported drugs can impact the availability and affordability of CHOLEDYL SA.
  • Regulatory Environment: Strengthening regulatory capacities is crucial for ensuring quality and safety standards, which can positively impact the market for drugs like CHOLEDYL SA.
  • Financial Trajectory: The financial health of CHOLEDYL SA is influenced by production costs, pricing strategies, and market demand, as well as investment in production capacity.
  • Competitive Landscape: The presence of follow-on drugs and the development of regional hubs can significantly impact the competitive landscape for CHOLEDYL SA.
  • Quality and Regulatory Compliance: Ensuring high quality and regulatory compliance is essential for maintaining market presence and financial health.

FAQs

What is the current market trend for prescription drug spending?

The current trend shows an increase in prescription drug spending, driven by growth in spending per prescription rather than an increase in the number of prescriptions[4].

How does the regulatory environment impact the pharmaceutical market in sub-Saharan Africa?

The regulatory environment significantly impacts the market by ensuring quality and safety standards. Countries like Ethiopia are investing in strengthening their regulatory capacities to reduce delays in product registration and eliminate counterfeit drugs[1].

What role do follow-on drugs play in the competitive landscape of pharmaceuticals?

Follow-on drugs provide similar therapeutic options and inject price competition into the marketplace, entering the market more quickly than in the past and potentially affecting the market share of drugs like CHOLEDYL SA[3].

How do demographic changes influence the demand for pharmaceuticals?

Demographic changes, such as population growth and age distribution, can drive up demand for pharmaceuticals. Regions with a high proportion of young people are likely to see an increase in the population at risk of various health conditions[5].

What is the impact of regional hubs on the pharmaceutical industry?

Regional hubs can create globally competitive industry clusters, leading to faster lead times and more responsive supply chains. This can benefit smaller countries and potentially reduce the market share of drugs not part of these hubs[1].

Sources

  1. McKinsey & Company - "Should sub-Saharan Africa make its own drugs?" (January 2019)
  2. JSTOR - (Not relevant to the topic)
  3. PubMed - "The economics of follow-on drug research and development" (2005)
  4. ASPE - "Trends in Prescription Drug Spending, 2016-2021" (September 2022)
  5. UNODC - "GLOBAL OVERVIEW: DRUG DEMAND DRUG SUPPLY" (2021)

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.