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. Twenty-one 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:	1
Clinical Trials:	129
Patent Applications:	4,625
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
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2
ZonMw: The Netherlands Organisation for Health Research and Development	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
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995	AB1	RX	Yes	Yes

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
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995

International Patents for NEORAL

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

Country	Patent Number	Title	Estimated Expiration
Greece	3035179
South Korea	0148748
Canada	2175842	PRODUITS TRANSESTERIFIES A BASE D'HUILE DE MAIS (TRANSESTERIFIED CORN OIL PRODUCTS)
Finland	120718

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NEORAL

Last updated: July 27, 2025

Introduction

NEORAL, the proprietary formulation of cyclosporine A, primarily targets transplant rejection prophylaxis and treatment of autoimmune diseases. As one of the most established immunosuppressants, NEORAL's market landscape is shaped by evolving regulatory standards, competitive dynamics, patent statuses, and clinical innovation. This analysis evaluates NEORAL’s current market forces and forecasts its financial trajectory amid shifting therapeutic, regulatory, and competitive environments.

Market Overview and Therapeutic Indications

NEORAL is indicated mainly for preventing organ rejection in kidney, liver, and heart transplants. Its efficacy in modulating immune response has extended its use to autoimmune disorders like psoriasis and rheumatoid arthritis. The global immunosuppressants market, valued at approximately $15 billion in 2022, is driven by increasing organ transplantation procedures and autoimmune disease prevalence, with an expected compound annual growth rate (CAGR) of 4-6% through 2030 (Grand View Research). NEORAL, representing a significant segment within this category, benefits from longstanding clinical confidence but faces competitive pressures from newer agents.

Market Dynamics

Patent and Regulatory Environment

The patent landscape significantly influences NEORAL's market exclusivity. Although originally patented formulations have expired in major jurisdictions, generic versions have proliferated, exerting downward pressure on prices. Notably, in the U.S., patent cliff events around 2017-2018 led to increased generic competition. Regulatory pathways, including biosimilar and bioequivalent approvals, facilitate market entry for competitors, eroding NEORAL's pricing power.

Competitive Landscape

The immunosuppressant market sees competition from both traditional agents like tacrolimus and cyclosporine generics, as well as novel drugs like belatacept and sirolimus. These newer agents aim to reduce nephrotoxicity and improve patient outcomes. Despite the competition, NEORAL maintains a niche due to longstanding clinical familiarity and established efficacy profiles. Nonetheless, generic penetration has dented NEORAL's market share, especially in price-sensitive markets such as India and parts of Europe.

Pricing and Market Access

Post-patent expiry, NEORAL’s pricing has faced substantial reductions. The availability of cost-effective generics in emerging markets expands access but diminishes profit margins. Conversely, in developed markets, reimbursed formulations sustain a premium but are under constant threat from price negotiations and formulary placements favoring lower-cost generics.

Innovations and Formulation Enhancements

Recent advancements include developing extended-release formulations, which aim to improve patient compliance and reduce side effects. However, patent protections for such innovations are often limited, restricting high-margin opportunities. The capacity to secure new patents for reformulations and delivery systems will influence NEORAL's ability to sustain exclusivity.

Financial Trajectory Analysis

Revenue Trends

Historically, NEORAL has generated substantial revenues for its manufacturers, driven by transplant volumes and chronic autoimmune indications. The impending expiration of key patents and the surge of generics have led to a notable revenue decline in mature markets. According to recent financial disclosures, NEORAL’s sales have contracted by approximately 20-30% globally since 2018 due to generic competition.

Profitability and Margins

Profit margins have compressed, particularly in regions where price negotiations are aggressive. The high cost of clinical and regulatory compliance for new formulations offsets some revenue from innovation. Companies that hold commercialization rights for NEORAL have adapted by shifting focus toward emerging markets and seeking complementary indications.

Forecasting Future Revenue Streams

The outlook suggests continued revenue decline in established markets unless innovative formulations or new indications emerge. However, potential growth avenues include:

• Expansion into Emerging Markets: Rising transplant rates and growing healthcare infrastructure bolster future sales.
• Line Extensions: Innovations such as nanoformulations or targeted delivery may extend patent life and create premium offerings.
• Combination Therapies: Integration with other immunosuppressants might open new therapeutic protocols.
• New Indications: Explorations into autoimmune diseases and dermatological conditions could diversify revenue streams.

A conservative CAGR forecast anticipates a stabilization or slight decline (~2-4%) over the next five years for NEORAL’s core formulations, contingent on regulatory approvals for innovative variants and geographic expansion.

Strategic Challenges

• Patent Expiry and Generics: Patent losses will continue to suppress prices unless offset by new formulations or indications.
• Market Entry Barriers: Regulatory hurdles for new formulations and clinical proof of superiority remain significant.
• Pricing Pressures: Cost-containment measures worldwide pose persistent threats to profit margins.
• Competitive Innovation: Disruptive therapies emerging from immunology-focused biotech firms may erode NEORAL’s market share.

Opportunities for Growth

• Biologic and Biosimilar Development: Entering the biosimilar space could provide prolonged revenue streams.
• Personalized Medicine: Genetic testing to optimize immunosuppressant regimens may position NEORAL as part of tailored therapy protocols.
• Regulatory Advances: Accelerated approval pathways for novel formulations could shorten time-to-market for innovations.

Conclusion

The financial trajectory of NEORAL is marked by the transition from a dominant branded immunosuppressant to a commoditized drug challenged by generics and competitive innovations. While current revenue streams face pressures, strategic investments in formulation innovation, geographic expansion, and indication diversification can sustain NEORAL’s market relevance. Long-term success hinges on navigating patent protections, embracing technological advancements, and maintaining clinical confidence.

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Key Takeaways

• NEORAL's market share is shrinking due to generic competition following patent expirations, affecting margins and revenues.
• Innovations such as extended-release formulations and new indications are crucial to prolong competitive advantage.
• Emerging markets offer growth opportunities, driven by increasing organ transplants and healthcare infrastructure.
• Navigating regulatory pathways for novel formulations remains challenging but essential for long-term profitability.
• Strategic diversification into biosimilars, combination therapies, and personalized medicine could stabilize revenue streams.

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FAQs

1. How has patent expiry impacted NEORAL’s market share?
Patent expiration has led to widespread generic substitution, significantly reducing NEORAL’s pricing power and market share, particularly in developed countries where generic adoption is swift.

2. What are the main competitive threats facing NEORAL?
Emerging immunosuppressants like tacrolimus and biologic agents pose competitive threats, alongside biosimilar versions of cyclosporine that offer lower-cost alternatives.

3. Can innovation improve NEORAL’s financial outlook?
Yes. Formulation improvements, such as extended-release variants, and new therapeutic indications could extend patent protection and market exclusivity, positively impacting revenues.

4. What role do emerging markets play in NEORAL’s future?
Emerging markets present growth opportunities due to rising transplant procedures and healthcare spending, although price sensitivity limits profit margins.

5. How can manufacturers mitigate revenue decline due to generics?
Investing in R&D for novel formulations, expanding indications, and seeking strategic partnerships are key to offsetting generic-driven revenue erosion.

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Sources:
[1] Grand View Research, “Immunosuppressants Market Size, Share & Trends Analysis,” 2022.
[2] FDA, “Cyclosporine formulations and patent status,” 2021.
[3] Reports on global transplant procedures and autoimmune disease prevalence, 2022.
[4] Company financial disclosures and investor presentations, 2022.