NEORAL Drug Patent Profile

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

Neoral is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in NEORAL 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 Neoral

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

Summary for NEORAL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	129
Patent Applications:	4,387
Drug Prices:	Drug price information for NEORAL
What excipients (inactive ingredients) are in NEORAL?	NEORAL excipients list
DailyMed Link:	NEORAL at DailyMed

See drug prices for NEORAL

Recent Clinical Trials for NEORAL

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

Sponsor	Phase
National Cord Blood Network	Phase 2
Fred Hutchinson Cancer Center	Phase 2
Erasmus Medical Center	N/A

See all NEORAL clinical trials

Pharmacology for NEORAL

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

US Patents and Regulatory Information for NEORAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995	AB1	RX	Yes	No
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	AB1	RX	Yes	Yes
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995		DISCN	Yes	No

Expired US Patents for NEORAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995	5,741,512
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	6,262,022
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995	6,258,808

International Patents for NEORAL

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	679118
Denmark	0953630
Finland	116199

Supplementary Protection Certificates for NEORAL

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

NEORAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neoral (Cyclosporine)

Introduction to Neoral

Neoral, a formulation of the immunosuppressive drug cyclosporine, has been a cornerstone in the management of various autoimmune and inflammatory diseases, as well as in organ transplantation. This article delves into the market dynamics and financial trajectory of Neoral, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Size and Growth Prospects

The cyclosporine drugs market, which includes Neoral, is anticipated to register a Compound Annual Growth Rate (CAGR) of 4.1% over the forecast period[1][4].

Impact of COVID-19

The COVID-19 pandemic posed significant challenges to the healthcare system, including the cyclosporine market. Outpatient treatments were postponed or restricted to minimize viral transmission, affecting the demand for chronic therapies like Neoral. Although cyclosporine was initially considered for COVID-19 management, clinical trials proved futile, leading to a temporary decline in its usage for this purpose[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Target Diseases

The growing prevalence of inflammatory and autoimmune diseases such as psoriasis, rheumatoid arthritis, and ulcerative colitis drives the demand for cyclosporine formulations like Neoral. In the United States alone, autoimmune illnesses affect over 22.5 million people, according to the National Institute of Environmental Health Sciences (NIH)[3].

New Product Approvals and Innovations

The market benefits from the introduction of new formulations and product approvals. For instance, the launch of Cequa (cyclosporine ophthalmic solution 0.09% w/v) by Sun Pharma in Canada, which uses nanomicellar technology to enhance bioavailability and ocular tissue penetration, contributes to market growth[4].

Advanced Formulations

Neoral itself is an advanced formulation of cyclosporine, using an ultramicronized form that forms microemulsions on contact with aqueous fluids. This formulation offers better absorption and more consistent blood trough levels compared to standard oral formulations, potentially reducing the administered dose and cost[5].

Regional Market Dynamics

North America

North America is expected to hold a significant share of the cyclosporine drugs market, driven by the presence of major industry players, high prevalence of target diseases, and supportive government initiatives. The region's growth is further bolstered by strategic product launches and government focus on disease prevention and treatment[1][4].

Europe and Other Regions

In Europe, partnerships such as the one between Sigmoid Pharma and Dr. Falk Pharma are crucial for advancing the pipeline of cyclosporine products. For example, Sigmoid’s CyCol and AlloCol candidates are poised for Phase III studies in Europe and North America, targeting indications like ulcerative colitis and graft versus host disease (GvHD)[2].

Competitive Landscape

The cyclosporine market is moderately competitive, with key players like Novartis AG, Sun Pharmaceutical Industries Ltd., and AbbVie Inc. actively involved in regional expansions and new product developments. These companies leverage their extensive resources and clinical expertise to maintain their market positions[1].

Financial Trajectory

Revenue and Market Share

The cyclosporine drugs market, including Neoral, is expected to grow significantly due to the increasing demand for effective therapies. The market's revenue is projected to increase, driven by new product approvals, favorable government policies, and the growing prevalence of target diseases.

Development Funding and Milestone Payments

Companies like Sigmoid Pharma receive development funding, milestone payments, and future tiered double-digit sales royalties through partnerships. For instance, Sigmoid’s deal with Dr. Falk Pharma includes such financial incentives, which are crucial for advancing their pipeline and commercializing products like CyCol and AlloCol[2].

Challenges and Opportunities

Lack of Awareness in Developing Regions

One of the significant challenges facing the cyclosporine market is the lack of awareness in developing regions, which affects the overall adoption of cyclosporine-based treatments. Addressing this through educational initiatives and partnerships could open up new market opportunities[1].

Innovative Delivery Systems

The development of innovative delivery systems, such as Sigmoid’s Single-Multi Pill (SmPill) platform, offers opportunities for targeted gastrointestinal delivery and improved patient outcomes. These advancements can enhance the market's growth by providing more effective and patient-friendly treatments[2].

Key Takeaways

• The cyclosporine drugs market, including Neoral, is expected to grow at a CAGR of 4.1% driven by increasing prevalence of autoimmune and inflammatory diseases.
• New product approvals and innovative formulations are key drivers of market growth.
• North America is expected to dominate the market due to high disease prevalence and supportive government initiatives.
• The competitive landscape is moderately intense with major players focusing on regional expansions and new product developments.
• Financial growth is supported by development funding, milestone payments, and royalties from partnerships.

FAQs

Q: What is the expected CAGR of the cyclosporine drugs market?

A: The cyclosporine drugs market is expected to register a CAGR of 4.1% over the forecast period[1][4].

Q: How did the COVID-19 pandemic affect the cyclosporine market?

A: The COVID-19 pandemic temporarily affected outpatient treatments and altered the usage dynamics of cyclosporine, although clinical trials for its use in COVID-19 management were futile[1][4].

Q: What are the key drivers of the cyclosporine market growth?

A: The growing prevalence of inflammatory and autoimmune diseases, new product approvals, and innovative formulations are key drivers of market growth[1][3][4].

Q: Which region is expected to dominate the cyclosporine market?

A: North America is expected to hold a significant share of the cyclosporine drugs market due to the presence of major industry players and high disease prevalence[1][4].

Q: What are some of the innovative formulations in the cyclosporine market?

A: Examples include Neoral’s ultramicronized form and Sigmoid’s Single-Multi Pill (SmPill) platform for targeted gastrointestinal delivery[2][5].

Sources:

1. Mordor Intelligence - Cyclosporine Drugs Market Size | Mordor Intelligence
2. Genetic Engineering & Biotechnology News - Sigmoid, Dr. Falk Ink Euro Deal for Phase III-Poised Cyclosporine Drug Platform
3. Maximize Market Research - Organ Transplant Immunosuppressant Drugs Market - Industry
4. Mordor Intelligence - Cyclosporine Drugs Market - Size, Share & Manufacturers
5. Mayo Clinic Proceedings - Cyclosporine in the Treatment of Dermatologic Disease: An Update