NILOTINIB TARTRATE - Generic Drug Details

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

Nilotinib tartrate is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nilotinib tartrate has seven patent family members in five countries.

One supplier is listed for this compound.

Summary for NILOTINIB TARTRATE

International Patents:	7
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	NILOTINIB TARTRATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NILOTINIB TARTRATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NILOTINIB TARTRATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NILOTINIB TARTRATE

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for NILOTINIB TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes			Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	No			Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	No			Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes			Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	No			Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes			Y

International Patents for NILOTINIB TARTRATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3914252	COMPOSITION PHARMACEUTIQUE DU NILOTINIB (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB)
China	113573712	尼洛替尼的药物组合物 (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB)
China	113573712
Japan	2022510732	ニロチニブの医薬組成物
Japan	2022510732	ニロチニブの医薬組成物
European Patent Office	4509123	COMPOSITION PHARMACEUTIQUE DU NILOTINIB (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB)
World Intellectual Property Organization (WIPO)	2020172120

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NILOTINIB TARTRATE

Last updated: July 28, 2025

Introduction

Nilotinib Tartrate, marketed under the brand name Tasigna among others, is a potent tyrosine kinase inhibitor primarily used for the treatment of chronic myeloid leukemia (CML). Since its FDA approval in 2007, Nilotinib has established itself as a critical therapeutic agent, particularly after resistance or intolerance to first-generation therapies like imatinib. This analysis explores the evolving market landscape, the financial trajectory of Nilotinib, and the strategic factors shaping its future growth prospects.

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Market Landscape Overview

The global pharmaceutical market for targeted therapies in hematologic malignancies, particularly CML, has experienced significant shifts over the past decade. Nilotinib operates within a competitive sphere that includes other TKIs such as dasatinib, bosutinib, and ponatinib. The key drivers, barriers, and the evolving competitive landscape determine the drug’s market position.

Epidemiology and Demand Drivers

CML affects approximately 1-2 per 100,000 individuals annually worldwide, with higher prevalence in developed nations due to better diagnosis and reporting [1]. The advent of BCR-ABL targeted therapies like Nilotinib has profoundly increased treatment efficacy, transforming CML into a manageable chronic condition with sustained remission in many cases.

The growing incidence of CML, especially in aging populations, combined with early diagnosis and expanding indications, bolsters the demand for Nilotinib. Notably, the increasing prevalence of comorbid conditions requiring cautious treatment selection further influences prescribing patterns.

Regulatory and Approval Pathways

Initially approved by the U.S. Food and Drug Administration (FDA) in 2007, Nilotinib's approval extensions have expanded its usage options, including for newly diagnosed patients and those resistant to prior therapy. Regulatory agencies in Europe and Asia have similarly endorsed its use, enhancing global market reach.

Competitive Dynamics

While generic versions of imatinib have precipitated market shifts, Nilotinib’s superior efficacy in certain resistant cases sustains its market. Moreover, the introduction of newer TKIs with improved safety profiles or specific activity against resistant mutations influences market share.

Pricing and Reimbursement Landscape

High drug costs, often exceeding $100,000 annually per patient, influence market dynamics. Reimbursement policies and formulary placements significantly impact access and sales volume. Cost-effectiveness analyses favor Nilotinib’s utilization in resistant cases, leading to broader payer acceptance.

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Financial Trajectory and Revenue Analysis

Historical Revenue Performance

Since its launch, Nilotinib’s revenues have demonstrated steady growth, driven by expanded indications and strategic market penetration efforts.

• U.S. Market: The United States remains the largest market, contributing approximately 50-60% of global sales. In 2022, estimates indicate annual sales exceeding $1.2 billion domestically, reflecting consistent demand [2].

• European and Asia-Pacific Markets: Europe accounts for over 20%, with emerging markets in Asia contributing gradually as regulatory approvals and healthcare infrastructure improve.

Revenue Growth Drivers

• Expanded Indications: Approval for front-line CML treatment increased patient population targets, contributing to revenue growth.
• Market Penetration & Adoption: Strong efficacy and safety profile attract prescribers, supported by clinical guidelines aligning Nilotinib as a preferred second-line therapy.
• Patent and Exclusivity Periods: Patent protections extend until approximately 2025-2027, delaying generic competition and supporting current pricing.

Impact of Generic Entry and Biosimilars

Post-patent expiration, the entry of biosimilar and generic competitors is anticipated, exerting downward pressure on prices. Historically, similar drugs saw 40-60% price reductions upon generic entry [3]. This transition could potentially dilute revenues by 2025-2027 unless strategies such as formulation improvements or combination therapies are pursued.

Market Expansion and Future Revenue Streams

The pipeline development for Nilotinib includes potential new indications, such as specific resistant mutation subsets or adjunctive therapy uses, though none are currently FDA-approved. International expansion into emerging markets remains a critical growth area, contingent on regulatory approvals and local pricing strategies.

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Strategic Factors Influencing Market and Financial Outlook

1. Innovative Pipeline Development: Enhancing Nilotinib’s formulation (e.g., extended-release) and generating data for combination regimens could sustain its competitive relevance amid biosimilar threats.

2. Patent Strategy and Legal Actions: Patent extensions and litigation can delay generic entry, prolonging exclusivity.

3. Pricing Strategies: Premium pricing supported by clinical benefits sustains revenue, but payers' migration towards cost-effective alternatives may pressure margins.

4. Market Penetration in Emerging Regions: Tailored pricing, local partnerships, and regulatory negotiations will determine market share expansion.

5. Competitive Landscape: The entry of next-gen TKIs with superior safety or resistance profiles can diminish Nilotinib's market share.

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Conclusion

Nilotinib Tartrate's market outlook remains cautiously optimistic. Its initial success, driven by efficacy and targeted indications, is likely to be challenged as patent protections lapse and competitors introduce biosimilars. Nevertheless, strategic product differentiation, international expansion, and pipeline innovation are critical for sustaining its financial trajectory.

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Key Takeaways

• Nilotinib's market is primarily defined by its role in resistant or intolerant CML, with substantial demand in developed markets.
• Revenue growth has been steady but faces inevitable decline post-patent expiry, with biosimilar competition expected around 2025-2027.
• Strategic initiatives such as pipeline expansion, formulation improvements, and patent protections are vital for maintaining profitability.
• Emerging markets present growth opportunities but require tailored strategies to overcome regulatory and cost barriers.
• Continuous clinical advancements and competitive positioning will shape Nilotinib’s long-term market presence.

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FAQs

1. When are generic versions of Nilotinib expected to enter the market?
Generic versions are anticipated around 2025-2027, contingent upon patent expiry timelines and legal protections.

2. How does Nilotinib compare to other TKIs in terms of efficacy and safety?
Nilotinib is generally more potent than imatinib and comparable to newer TKIs like dasatinib but may have different safety profiles, including risks of cardiovascular adverse events.

3. What are the primary challenges facing Nilotinib's market growth?
Challenges include patent expiration, biosimilar competition, evolving treatment guidelines favoring newer agents, and high treatment costs impacting payer decisions.

4. Are there ongoing clinical trials to expand Nilotinib's indications?
Yes, clinical trials are ongoing to evaluate Nilotinib in resistant mutations, combination therapies, and potential new indications, which may extend its lifecycle.

5. What strategies can pharmaceutical companies employ to sustain Nilotinib’s revenues?
Strategies include pipeline innovation, optimizing formulations, expanding into underserved markets, and leveraging strategic patent protections.

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References

[1] Baccarani, M., et al. (2013). Chronic Myeloid Leukemia: An Update of Current Treatment Strategies. The Journal of Clinical Oncology.
[2] IQVIA. (2022). Global Oncology Market Data.
[3] Kesselheim, A. S., et al. (2017). The Impact of Patent Expiration on Drug Prices and Market Competition. New England Journal of Medicine.