SANDIMMUNE Drug Patent Profile

When do Sandimmune patents expire, and what generic alternatives are available?

Sandimmune is a drug marketed by Novartis and is included in three NDAs.

The generic ingredient in SANDIMMUNE 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 Sandimmune

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

Summary for SANDIMMUNE

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	99
Patent Applications:	4,401
Drug Prices:	Drug price information for SANDIMMUNE
What excipients (inactive ingredients) are in SANDIMMUNE?	SANDIMMUNE excipients list
DailyMed Link:	SANDIMMUNE at DailyMed

See drug prices for SANDIMMUNE

Recent Clinical Trials for SANDIMMUNE

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

Sponsor	Phase
National Cord Blood Network	Phase 2
Fred Hutchinson Cancer Center	Phase 2
Berinstein, Jeffrey	Phase 4

See all SANDIMMUNE clinical trials

Pharmacology for SANDIMMUNE

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

US Patents and Regulatory Information for SANDIMMUNE

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	050625-001	Mar 2, 1990	AB2	RX	Yes	No
Novartis	SANDIMMUNE	cyclosporine	INJECTABLE;INJECTION	050573-001	Nov 14, 1983	AP	RX	Yes	Yes
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-003	Nov 23, 1992	BX	RX	Yes	No
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-002	Mar 2, 1990	AB2	RX	Yes	Yes
Novartis	SANDIMMUNE	cyclosporine	SOLUTION;ORAL	050574-001	Nov 14, 1983		RX	Yes	Yes

Expired US Patents for SANDIMMUNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-001	Mar 2, 1990
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-002	Mar 2, 1990
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-003	Nov 23, 1992

International Patents for SANDIMMUNE

See the table below for patents covering SANDIMMUNE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H02255623	NOVEL CYCLOSPORINE DRUG
Germany	4005190
Italy	9047650
France	2643262	COMPOSITIONS PHARMACEUTIQUES A BASE DE CYCLOSPORINES
Belgium	1005236	COMPOSITIONS PHARMACEUTIQUES A BASE DE CYCLOSPORINES.
United Kingdom	2228198	NOVEL CYCLOSPORIN GALENIC FORMS

Supplementary Protection Certificates for SANDIMMUNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323

SANDIMMUNE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SANDIMMUNE (Cyclosporine)

Introduction to SANDIMMUNE (Cyclosporine)

SANDIMMUNE, also known as cyclosporine, is a potent immunosuppressant drug that plays a crucial role in preventing the rejection of transplanted organs and treating various autoimmune diseases. Here, we will delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Market Size and Forecast

The cyclosporine market, which includes SANDIMMUNE, is experiencing substantial growth. As of 2024, the cyclosporine market size was valued at $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].

Key Drivers of Market Growth

Organ Transplant Rejection Prevention

One of the primary drivers of the cyclosporine market is its efficacy in preventing organ transplant rejection. This application is critical and continues to drive demand as the number of organ transplants increases globally[1].

Treatment of Autoimmune Diseases

Cyclosporine is also widely used in the treatment of autoimmune diseases such as rheumatoid arthritis and psoriasis. The increasing prevalence of these conditions, particularly among the geriatric population, contributes significantly to market growth[1].

Growing Health Concerns and Awareness

The rise in health concerns related to autoimmune diseases and the increasing awareness about these conditions are further boosting the demand for cyclosporine. Additionally, factors such as exposure to certain minerals and the inclination towards smoking, which can lead to atrophic arthritis, are contributing to the market's expansion[1].

Market Segmentation

By Type

The cyclosporine market is segmented into pills and oral liquid forms. The pills segment is expected to grow the most during the forecast period due to their ease of use, slow and easy administration, and fast onset of action[1].

By Application

Cyclosporine is used in various applications, including organ transplantation, rheumatoid arthritis, and psoriasis. The diverse range of applications ensures a steady demand for the drug.

By Geography

North America currently holds the largest market share due to the presence of major market players and the high prevalence of autoimmune diseases. However, the Asia Pacific region is expected to grow at the highest CAGR over the forecast period, driven by increasing healthcare investments and the growing need for immunosuppressants[4].

Financial Performance and Projections

Revenue Growth

The significant growth rate of 14.96% CAGR from 2024 to 2031 indicates a robust financial trajectory for the cyclosporine market. This growth is driven by the increasing demand for the drug in various medical applications[1].

Key Players

Major players in the cyclosporine market include Novartis AG, AbbVie Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Santen Pharmaceutical Co., Ltd. These companies are investing heavily in research and development, product launches, and strategic collaborations to maintain their market positions[4].

Challenges and Restraints

Side Effects and Health Concerns

Despite its benefits, cyclosporine is associated with several side effects, including kidney problems, high blood pressure, gum disease, tremors, and increased hair growth. These health concerns can hamper market growth as patients and healthcare providers seek alternative treatments with fewer adverse effects[1].

Generic Competition

The cyclosporine market also faces competition from generic versions of the drug. The loss of patents for several branded products and the availability of low-priced substitutes can reduce the market share of branded drugs like SANDIMMUNE[3].

Impact of COVID-19

During the COVID-19 pandemic, the use of cyclosporine was explored for managing the infection, but clinical trials were ultimately terminated due to futility. This development had a temporary negative impact on the market, as the number of patients using cyclosporine for COVID-19 treatment decreased[4].

Regional Dynamics

North America

North America dominates the cyclosporine market due to the presence of major pharmaceutical companies and a high prevalence of autoimmune diseases. Government initiatives aimed at preventing and treating these diseases also contribute to the region's significant market share[4].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market for cyclosporine. This growth is driven by increasing investments in the healthcare sector, the rising adoption of immunosuppressants, and favorable reimbursement scenarios in countries like Japan, China, and India[4].

Key Takeaways

• The cyclosporine market, including SANDIMMUNE, is projected to grow significantly, reaching $8.26 billion by 2031.
• The market is driven by its use in organ transplantation and the treatment of autoimmune diseases.
• North America holds the largest market share, but the Asia Pacific region is expected to grow at the highest CAGR.
• Major players are investing in R&D and strategic collaborations to maintain market positions.
• Side effects and generic competition are key challenges facing the market.

FAQs

What is the primary use of SANDIMMUNE (cyclosporine)?

SANDIMMUNE (cyclosporine) is primarily used to prevent organ transplant rejection and to treat various autoimmune diseases such as rheumatoid arthritis and psoriasis.

Which region is expected to grow the fastest in the cyclosporine market?

The Asia Pacific region is expected to grow at the highest CAGR over the forecast period due to increasing healthcare investments and the growing need for immunosuppressants.

What are the major side effects associated with cyclosporine?

Cyclosporine is associated with side effects such as kidney problems, high blood pressure, gum disease, tremors, and increased hair growth.

Who are the key players in the cyclosporine market?

Major players include Novartis AG, AbbVie Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Santen Pharmaceutical Co., Ltd.

How has the COVID-19 pandemic affected the cyclosporine market?

The COVID-19 pandemic had a temporary negative impact on the market as clinical trials for using cyclosporine to manage COVID-19 infection were terminated due to futility.

Sources

1. Verified Market Research: Cyclosporine Market Size, Share, Trends & Forecast
2. Novartis: US securities & Exchange commission form 20-F 2013
3. SkyQuestT: Myasthenia Gravis Treatment Market Size, Share, Growth Analysis
4. Mordor Intelligence: Cyclosporine Drugs Market - Size, Share & Manufacturers
5. Novartis: Q2 2024 Impact and Sustainability Update to investors