Cyclosporine - Generic Drug Details

What are the generic drug sources for cyclosporine and what is the scope of patent protection?

Cyclosporine is the generic ingredient in nine branded drugs marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Softgels, Abbvie, Novartis, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Harrow Eye, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-eight NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has three hundred and nine patent family members in thirty-four countries.

There are eighteen drug master file entries for cyclosporine. Nineteen suppliers are listed for this compound.

Summary for cyclosporine

International Patents:	309
US Patents:	21
Tradenames:	9
Applicants:	17
NDAs:	28
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1,059
Patent Applications:	7,398
Drug Prices:	Drug price trends for cyclosporine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cyclosporine
What excipients (inactive ingredients) are in cyclosporine?	cyclosporine excipients list
DailyMed Link:	cyclosporine at DailyMed

See drug prices for cyclosporine

Recent Clinical Trials for cyclosporine

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

Sponsor	Phase
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2
Assiut University	Phase 1

See all cyclosporine clinical trials

Pharmacology for cyclosporine

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for cyclosporine

Antifungal Agents

Antirheumatic Agents

Calcineurin Inhibitors

Dermatologic Agents

Enzyme Inhibitors

Immunosuppressive Agents

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
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-002	Mar 2, 1990	AB2	RX	Yes	Yes
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	10,441,630		Y
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes	10,813,976		Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	8,524,779		Y

Expired US Patents for cyclosporine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-001	Mar 2, 1990	7,511,014
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,648,048
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995	6,007,840
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995	5,741,512

International Patents for cyclosporine

Country	Patent Number	Title	Estimated Expiration
Spain	2974839
Japan	5894202
Japan	2019006803	ドライアイ症候群の治療のための医薬組成物 (PHARMACEUTICAL COMPOSITION FOR TREATMENT OF DRY EYE SYNDROME)
Japan	2010168118	DISPENSER

Supplementary Protection Certificates for cyclosporine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1809237	CA 2015 00030	Denmark		PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 20150319
2049079	PA2017003	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237	300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP EMULSION); REGISTRATION NO/DATE: EU/1/15/990 20150323
1809237	C300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319

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