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Last Updated: December 22, 2024

CYCLOSPORINE Drug Patent Profile


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

Cyclosporine is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg. and is included in eighteen NDAs.

The generic ingredient in CYCLOSPORINE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cyclosporine

A generic version of CYCLOSPORINE was approved as cyclosporine by HIKMA on October 29th, 1999.

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Drug patent expirations by year for CYCLOSPORINE
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Recent Clinical Trials for CYCLOSPORINE

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

SponsorPhase
Fred Hutchinson Cancer CenterPhase 2
National Cord Blood NetworkPhase 2
Assiut UniversityPhase 1

See all CYCLOSPORINE clinical trials

Paragraph IV (Patent) Challenges for CYCLOSPORINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RESTASIS MULTIDOSE Ophthalmic Emulsion cyclosporine 0.05% 050790 1 2014-01-13

US Patents and Regulatory Information for CYCLOSPORINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex CYCLOSPORINE cyclosporine CAPSULE;ORAL 065040-001 May 9, 2002 AB2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan CYCLOSPORINE cyclosporine EMULSION;OPHTHALMIC 205894-001 Feb 2, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Sa CYCLOSPORINE cyclosporine SOLUTION;ORAL 065054-001 Dec 18, 2001 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

CYCLOSPORINE Market Analysis and Financial Projection Experimental

Cyclosporine Market Dynamics and Financial Trajectory

Introduction to Cyclosporine

Cyclosporine, an immunosuppressant drug, has been a cornerstone in the medical field for several decades, particularly in the prevention and treatment of organ transplant rejection and various autoimmune diseases. Here, we delve into the market dynamics and financial trajectory of cyclosporine, highlighting its current status, growth prospects, and the factors influencing its market.

Market Size and Forecast

The cyclosporine market is experiencing significant growth, driven by its diverse medical applications. As of 2024, the global cyclosporine market size was valued at approximately $2.99 billion and is projected to reach $8.26 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 14.96% from 2024 to 2031[1].

Another estimate suggests that the market was valued at $3.05 billion in 2022 and is expected to reach $7.58 billion by 2029, with a CAGR of 13.86% over the forecast period[3].

Key Drivers of Market Growth

Prevention of Organ Transplant Rejection

One of the primary drivers of the cyclosporine market is its critical role in preventing organ transplant rejection. Cyclosporine works by lowering the immune system's defenses, allowing the body to accept the transplanted organ without rejection[1].

Treatment of Autoimmune Diseases

Cyclosporine is widely used in the treatment of various autoimmune diseases, including rheumatoid arthritis, psoriasis, and atopic dermatitis. Its efficacy in reducing inflammation and modulating the immune response has made it a preferred treatment option for these conditions[1][5].

Geriatric Population

The increasing geriatric population is another factor contributing to the growth of the cyclosporine market. As the population ages, the demand for treatments that manage chronic conditions such as arthritis and other autoimmune diseases is expected to rise[1].

Regional Market Dynamics

Asia Pacific: Fastest Growing Region

The Asia Pacific region is anticipated to be the fastest-growing market for cyclosporine, driven by increasing healthcare expenditure, a growing elderly population, and improving healthcare infrastructure[4].

North America: Largest Market Share

North America currently holds the largest market share in the cyclosporine market, due to advanced healthcare systems, high adoption rates of immunosuppressive therapies, and significant research and development activities in the region[4].

Economic and Clinical Impact

Cost Considerations

The introduction of cyclosporine significantly improved solid organ transplantation outcomes but also increased the costs associated with immunosuppressive therapy. For instance, the annual cost per patient increased from $1,000 to $2,000 with traditional therapies to $5,000 to $8,000 with the addition of cyclosporine[2].

Cyclosporine-Sparing Agents

To mitigate these costs, research has focused on developing drug combinations that can reduce the dosage of cyclosporine while maintaining its therapeutic effects. Drugs like ketoconazole and diltiazem have been identified as potential cyclosporine-sparing agents, allowing for a reduction in cyclosporine dosages by 70-85% and 30-50%, respectively, without severe adverse effects[2].

Challenges and Restraints

Drug Toxicity and Relapse

Despite its benefits, cyclosporine is associated with several challenges, including drug toxicity, particularly nephrotoxicity, and high rates of relapse after treatment cessation. These factors limit its use to diseases that are refractory to other therapies[5].

COVID-19 Impact

The COVID-19 pandemic had a mixed impact on the cyclosporine market. While cyclosporine was initially explored as a potential treatment for COVID-19, clinical trials were ultimately terminated due to futility. This led to a decrease in its use for COVID-19 treatment, which had unfavorable consequences for the market[4].

Competitive Landscape

The cyclosporine market is dominated by several key players, including AbbVie Inc., Novartis AG, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Santen Pharmaceutical Co., Ltd. These companies are involved in continuous research and development to improve the efficacy and safety profile of cyclosporine[4].

Future Prospects

The future of the cyclosporine market looks promising, driven by its expanding applications in dermatology and other autoimmune diseases. Advances in drug formulations and the development of cyclosporine-sparing agents are expected to enhance its therapeutic profile and reduce costs, making it more accessible to a broader patient population.

"Cyclosporine has been in clinical use for 2 decades, primarily for the prevention and treatment of organ transplant rejection and graft-versus-host disease. In more recent years, it has been recognized as beneficial in the treatment of dermatologic diseases." - Mayo Clinic Proceedings[5]

Key Takeaways

  • The global cyclosporine market is projected to grow significantly, driven by its role in organ transplant rejection and treatment of autoimmune diseases.
  • The Asia Pacific region is expected to be the fastest-growing market, while North America holds the largest market share.
  • Cyclosporine-sparing agents are being developed to reduce costs and improve therapeutic outcomes.
  • Despite its benefits, cyclosporine faces challenges such as drug toxicity and high relapse rates.
  • The COVID-19 pandemic had a mixed impact on the market, with initial exploration as a COVID-19 treatment ultimately proving futile.

FAQs

What is the current market size of the cyclosporine market?

The cyclosporine market was valued at approximately $2.99 billion in 2024[1].

What is the projected growth rate of the cyclosporine market?

The market is expected to grow at a CAGR of 14.96% from 2024 to 2031[1].

Which region is the fastest-growing market for cyclosporine?

The Asia Pacific region is the fastest-growing market for cyclosporine[4].

What are the primary applications of cyclosporine?

Cyclosporine is primarily used in preventing organ transplant rejection and treating various autoimmune diseases such as rheumatoid arthritis and psoriasis[1][5].

What are the challenges associated with cyclosporine use?

Cyclosporine is associated with drug toxicity, particularly nephrotoxicity, and high rates of relapse after treatment cessation[5].

Sources:

  1. Verified Market Research - Cyclosporine Market Size, Share, Trends & Forecast
  2. PubMed - The clinical and economic potential of cyclosporin drug interactions
  3. Maximize Market Research - Cyclosporine Market – Global Industry Analysis and Forecast (2023 ...
  4. Mordor Intelligence - Cyclosporine Drugs Market - Size, Share & Manufacturers
  5. Mayo Clinic Proceedings - Cyclosporine in the Treatment of Dermatologic Disease: An Update

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