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Last Updated: March 26, 2025

PRELONE Drug Patent Profile


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Which patents cover Prelone, and what generic alternatives are available?

Prelone is a drug marketed by Muro and Teva and is included in two NDAs.

The generic ingredient in PRELONE is prednisolone. There are eighty-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prelone

A generic version of PRELONE was approved as prednisolone by ZHEJIANG XIANJU on May 2nd, 2024.

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Summary for PRELONE
Drug patent expirations by year for PRELONE
Recent Clinical Trials for PRELONE

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

SponsorPhase
Children's Oncology GroupPhase 2
Children's Oncology GroupPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2

See all PRELONE clinical trials

US Patents and Regulatory Information for PRELONE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Teva PRELONE prednisolone SYRUP;ORAL 089081-001 Feb 4, 1986 AA RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Muro PRELONE prednisolone SYRUP;ORAL 089654-001 Jan 17, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

EU/EMA Drug Approvals for PRELONE

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
LE VET B.V. Equisolon Prednisolone EMEA/V/C/002382
Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.
Authorised no no no 2014-03-12
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Prednisolone (PRELONE)

Introduction

Prednisolone, a synthetic glucocorticoid, is a crucial medication in the pharmaceutical industry, particularly for its anti-inflammatory and immunosuppressive properties. This article delves into the market dynamics, growth drivers, and financial trajectory of prednisolone, highlighting its significance and future prospects.

Market Size and Projection

The global prednisolone market is experiencing substantial growth, driven by increasing demand for effective treatments of chronic diseases. As of 2023, the market size was valued at USD 0.16 billion and is projected to reach USD 0.34 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 8.14%[4].

Key Drivers of Market Growth

Several factors are driving the growth of the prednisolone market:

Increasing Prevalence of Chronic Diseases

The rising incidence of chronic diseases such as asthma, allergies, and autoimmune disorders like lupus and rheumatoid arthritis is a primary driver. These conditions necessitate effective treatment options, leading to higher demand for prednisolone[1].

Advancements in Drug Formulations

Recent innovations in drug formulations, including extended-release and combination therapies, are enhancing the efficacy of prednisolone. These advancements include new delivery systems such as inhalers and injectables, which improve patient compliance and therapeutic outcomes[1].

Greater Awareness and Access to Healthcare

Increased awareness about the benefits of prednisolone and improved access to healthcare facilities are contributing to the market's expansion. Patients are seeking more effective treatments for chronic conditions, leading to a higher demand for prednisolone prescriptions[1].

Market Trends

New Product Launches

Pharmaceutical companies are continually introducing new formulations of prednisolone to cater to diverse patient needs. These launches include innovative delivery systems that enhance patient compliance and therapeutic outcomes[1].

Strategic Partnerships

Strategic partnerships between pharmaceutical companies and research institutions are fostering innovation in the prednisolone market. These collaborations aim to develop more effective and targeted therapies, further solidifying prednisolone's position in the pharmaceutical landscape[1].

Mergers and Acquisitions

The prednisolone market has seen a rise in mergers and acquisitions, allowing companies to consolidate resources and expand their market presence. This trend is expected to continue as businesses seek to enhance their product offerings and improve operational efficiencies[1].

Financial Trajectory

Investment Opportunities

The prednisolone market presents lucrative investment opportunities, particularly in research and development. As the demand for effective treatments rises, pharmaceutical companies are focusing on expanding their product portfolios to include various formulations of prednisolone[1].

Revenue Projections

The market's financial trajectory is promising, with significant revenue growth projected. The increasing prevalence of chronic diseases and advancements in pharmaceutical research are key factors driving this growth[1].

Key Players

Several key players dominate the prednisolone market:

  • Shandong Taihua Bio &Tech
  • Mahima Life Sciences
  • Sanofi
  • Wuhan DKY Technology
  • Xianju Pharma

These companies are at the forefront of innovation and market expansion in the prednisolone sector[4].

Impact of Regulatory and Technological Advancements

Regulatory Clearances

Advancements in regulatory clearances, such as those seen in other pharmaceutical sectors, can significantly impact the prednisolone market. For instance, the clearance of new gene editing technologies by regulatory bodies can pave the way for more targeted and effective treatments[2].

Technological Innovations

Technological innovations, including new delivery systems and formulations, are crucial for the market's growth. These innovations not only enhance the efficacy of prednisolone but also improve patient compliance and outcomes[1].

Challenges and Considerations

Side Effects and Long-term Use

Prednisolone, like other corticosteroids, comes with potential side effects such as weight gain, increased appetite, and mood changes. Long-term use can lead to more serious complications, which can impact market dynamics and patient adherence[1].

Economic Ramifications

The economics of drug development, including pricing and innovation, play a significant role in the market. The ability to develop products aimed at small patient populations can change optimal pricing strategies and influence the structure of government research and development incentives[5].

Future Outlook

Continued Growth

The future of the prednisolone market appears promising, with continued growth expected. Factors such as ongoing research, technological advancements, and a focus on personalized medicine are likely to shape the market landscape. As healthcare providers strive for better treatment outcomes, the demand for prednisolone is anticipated to rise[1].

Pipeline Drugs

New drugs in the pipeline are expected to account for a significant portion of spending growth in the next few years. The University of Maryland researchers predict that pipeline drugs will account for 40 to 50 percent of spending growth in the next five years, which could further propel the prednisolone market[3].

Key Takeaways

  • The global prednisolone market is projected to grow significantly, driven by the increasing prevalence of chronic diseases and advancements in pharmaceutical research.
  • New product launches, strategic partnerships, and mergers and acquisitions are key trends in the market.
  • The market presents lucrative investment opportunities, particularly in research and development.
  • Technological innovations and regulatory clearances are crucial for market growth.
  • Despite challenges such as side effects and economic considerations, the future outlook for the prednisolone market is promising.

FAQs

What is the projected market size of prednisolone by 2032?

The global prednisolone market is expected to reach USD 0.34 billion by 2032[4].

What is the CAGR of the global prednisolone market?

The global prednisolone market is expected to exhibit a CAGR of 8.14% by 2032[4].

What are the primary drivers of the prednisolone market?

The primary drivers include the increasing prevalence of chronic diseases, advancements in drug formulations, and greater awareness among patients[1].

Which companies are key players in the prednisolone market?

Key players include Shandong Taihua Bio &Tech, Mahima Life Sciences, Sanofi, Wuhan DKY Technology, and Xianju Pharma[4].

What are the potential side effects of long-term prednisolone use?

Long-term use of prednisolone can lead to serious complications, including weight gain, increased appetite, and mood changes[1].

Sources

  1. Market Research Intellect: Prednisolone Market Size And Projection - Market Research Intellect
  2. Prime Medicine: Prime Medicine Reports Second Quarter 2024 Financial Results and Provides Business Updates
  3. ASPE: Explaining the Growth in Prescription Drug Spending: A Review of Recent Studies
  4. Business Research Insights: Prednisolone Market Growth, Size, Share and Forecast [2032]
  5. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market

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