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

Last Updated: December 25, 2024

ORASONE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Orasone, and when can generic versions of Orasone launch?

Orasone is a drug marketed by Solvay and is included in two NDAs.

The generic ingredient in ORASONE is prednisone. There are sixteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Orasone

A generic version of ORASONE was approved as prednisone by WATSON LABS on December 31st, 1969.

  Subscribe

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mayo ClinicPhase 2
ADC TherapeuticsPhase 2
Joseph TuscanoPhase 2

See all ORASONE clinical trials

US Patents and Regulatory Information for ORASONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay ORASONE prednisone TABLET;ORAL 083009-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Solvay ORASONE prednisone TABLET;ORAL 083009-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Solvay ORASONE prednisone TABLET;ORAL 083009-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Solvay ORASONE prednisone TABLET;ORAL 083009-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Solvay ORASONE prednisone TABLET;ORAL 085999-001 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

ORASONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Orasone (Prednisone)

Introduction

Orasone, commonly known as Prednisone, is a corticosteroid used to treat a variety of conditions including inflammatory diseases, immune system diseases, and some types of cancer. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, healthcare providers, and policymakers.

Market Overview

Therapeutic Use

Prednisone is a widely used corticosteroid, prescribed for its anti-inflammatory and immunosuppressive properties. It is used in the treatment of various conditions such as rheumatoid arthritis, psoriasis, asthma, and certain types of cancer[4].

Market Segment

Prednisone falls under the category of generic and off-patent drugs, which are often subject to different market dynamics compared to branded and patented drugs. The generic and biosimilar markets are highly competitive and often characterized by low prices and significant price erosion[1].

Pricing Dynamics

Price Erosion

One of the key factors affecting the market dynamics of Prednisone is price erosion. The generic market, where Prednisone is positioned, is known for low prices and high competition. This leads to a continuous decline in prices, making it less profitable for manufacturers. Price erosion is not driven by competition between manufacturers, as the markets are highly concentrated, but rather by other dynamics such as tenders and government policies[1].

Impact on Manufacturers

The low-profit margins and significant price erosion in the generic market can lead to oligopolies, where only a few manufacturers remain in the market. This reduces the resilience of the market to demand increases or supply issues, thereby increasing the risk of drug shortages. Prednisone, being an off-patent drug, is particularly vulnerable to these market conditions[1].

Demand and Supply

Demand Factors

The demand for Prednisone can fluctuate based on various factors, including the prevalence of the conditions it treats and changes in healthcare policies. For instance, an increase in the incidence of autoimmune diseases or inflammatory conditions can drive up the demand for Prednisone. Additionally, government initiatives and public health campaigns can influence demand patterns[1].

Supply Chain

The supply chain for generic drugs like Prednisone is often complex and global. Disruptions in the supply chain, such as manufacturing issues or raw material shortages, can lead to drug shortages. The COVID-19 pandemic has highlighted the vulnerability of global supply chains, leading to increased shortages of essential drugs, including Prednisone[1].

Financial Trajectory

Revenue and Profitability

The financial trajectory of Prednisone is influenced by its status as a generic drug. The revenue generated from Prednisone is typically lower compared to branded drugs due to the competitive nature of the generic market. Profit margins are slim, and manufacturers often struggle to maintain profitability in the face of continuous price erosion[1].

Cost Savings Initiatives

Government and healthcare organizations often implement cost-saving initiatives that can impact the financial trajectory of drugs like Prednisone. For example, the Medicare Drug Price Negotiation Program aims to lower drug costs by negotiating prices with drug companies. While such initiatives can reduce healthcare costs, they can also further compress the profit margins of generic drug manufacturers[2].

Regulatory Environment

Policy Impacts

Regulatory policies play a significant role in shaping the market dynamics and financial trajectory of Prednisone. Policies aimed at reducing drug prices, such as those under the Inflation Reduction Act, can lead to negotiated prices that are lower than current market prices. These policies, while beneficial for patients, can further reduce the profitability of generic drugs[2].

Competitive Landscape

Market Concentration

The market for Prednisone is highly concentrated, with a few large manufacturers dominating the landscape. This concentration can lead to a lack of competition, which in turn can result in higher risks of drug shortages and reduced market resilience[1].

New Entrants

While new entrants into the generic market can increase competition, they often face significant barriers to entry, including high regulatory hurdles and the need for substantial investment in manufacturing and distribution. This limits the number of new players in the market, maintaining the oligopolistic structure[1].

Future Outlook

Market Forecast

The future outlook for Prednisone is tied to the broader trends in the generic and biosimilar markets. As the demand for cost-effective treatments continues to rise, the market for Prednisone is expected to remain stable but with ongoing pressure on prices. The entry of new generic manufacturers and biosimilars could further intensify competition and drive down prices[1].

Innovation and R&D

While Prednisone itself is not a subject of significant innovation, the broader corticosteroid market is seeing advancements in terms of new formulations and delivery methods. These innovations could potentially impact the market dynamics of Prednisone by offering alternative treatment options with improved efficacy and safety profiles[4].

Key Takeaways

  • Price Erosion: The generic market for Prednisone is characterized by significant price erosion, driven by factors such as tenders and government policies.
  • Market Concentration: The market is highly concentrated, leading to oligopolies and increased risks of drug shortages.
  • Demand and Supply: Demand can fluctuate based on disease prevalence and healthcare policies, while supply chain disruptions can lead to shortages.
  • Financial Trajectory: Revenue and profitability are impacted by low prices and slim profit margins.
  • Regulatory Environment: Policies aimed at reducing drug prices can further compress profit margins.
  • Competitive Landscape: The market is dominated by a few large manufacturers, with significant barriers to entry for new players.

FAQs

What are the main factors contributing to the price erosion of Prednisone?

The main factors contributing to the price erosion of Prednisone include tenders, government policies, and the highly competitive nature of the generic market.

How does the COVID-19 pandemic impact the supply chain of Prednisone?

The COVID-19 pandemic has highlighted the vulnerability of global supply chains, leading to increased shortages of essential drugs, including Prednisone, due to manufacturing issues and raw material shortages.

What are the implications of the Medicare Drug Price Negotiation Program for Prednisone?

The Medicare Drug Price Negotiation Program aims to lower drug costs by negotiating prices with drug companies, which can further reduce the profit margins of generic drug manufacturers like those producing Prednisone.

How does market concentration affect the availability of Prednisone?

Market concentration in the generic market for Prednisone can lead to a lack of competition, resulting in higher risks of drug shortages and reduced market resilience.

What are the future trends expected in the market for Prednisone?

The future outlook for Prednisone includes stable demand but ongoing pressure on prices, with potential competition from new generic manufacturers and biosimilars, and innovations in corticosteroid treatments.

Sources

  1. The Dynamics of Drug Shortages - Office of Health Economics
  2. Medicare Drug Price Negotiation Program - CMS
  3. Report: Obesity Drug Market Estimated to be Worth $200 Billion by 2031 - Pharm Exec
  4. Global Multiple Myeloma Drugs Market - MarketsandMarkets
  5. Opioid Overdose Reversal Medications (OORM) - SAMHSA

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.