Nilotinib tartrate - Generic Drug Details

What are the generic sources for nilotinib tartrate and what is the scope of freedom to operate?

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	Yes			Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	Yes			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
World Intellectual Property Organization (WIPO)	2020172120
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)
European Patent Office	3914252

Market Dynamics and Financial Trajectory for Nilotinib Tartrate

Last updated: February 15, 2026

Nilotinib tartrate, marketed under brand names like Tasigna, is a second-generation BCR-ABL tyrosine kinase inhibitor used primarily for chronic myeloid leukemia (CML). Its lifecycle and financial prospects are shaped by regulatory status, competitive landscape, clinical data, and market demand.

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Regulatory Status and Patent Landscape

• FDA Approval: Approved in 2007 for Philadelphia chromosome-positive CML.
• Orphan Drug Designation: Nilotinib holds orphan status in some markets, potentially extending exclusivity.
• Patent Timeline: Initially patented until late 2010s. Patent expiry occurred around 2019-2020 in key markets like the US and EU.
• Generic Entry: After patent expiry, generic versions entered markets, leading to price erosion.

Market Size and Growth Drivers

• Global CML Market: Estimated to exceed $3 billion by 2027, with an annual growth rate (CAGR) of about 5%.
• Market Share: Nilotinib's share peaked around 40% in 2015 but declined post-generic entry.
• Patient Population: Approximately 8,000–10,000 new CML cases annually in the US; global cases rising due to better diagnostics and awareness.

Competitive Landscape

• Main Competitors: Imatinib (Gleevec) remains first-line; dasatinib and bosutinib represent second-generation options.
• Generic Competition: Generics cost 50-70% less than branded nilotinib. Labels like Alvotech and Dr. Reddy's launched biosimilars.
• Emerging Therapies: New agents targeting resistant CML cases, like asciminib, may alter market share.

Pricing and Revenue Trends

• Brand Pricing: Originally priced at $9,000–$12,000/month.
• Post-Patent Erosion: Prices dropped to approximately $2,500–$4,000/month post-generic entry.
• Revenue Decline: Branded sales declined from peak estimates of $800 million annually to around $200–400 million in recent years.

Key Market Dynamics

• Regulatory and Patent Expiry: Led to a rapid shift from branded to generic formulations.
• Market Penetration: Nilotinib remains prescribed, especially for patients intolerant to imatinib, but its share has diminished.
• Treatment Guidelines: Favor newer and more selective agents in resistant or intolerant cases, impacting nilotinib demand.
• Pricing Pressures: Increased use of biosimilars and affordability initiatives continue to press down prices.

Financial Trajectory Outlook

• Short Term (1-3 years): Revenue continues to decline as generics dominate. Estimated branded sales may fall below $200 million.
• Medium Term (3-5 years): Market stabilizes with a diminishing niche for branded nilotinib. Revenues likely to plateau or decline further.
• Long Term (>5 years): Potential obsolescence in favor of novel agents with superior safety or efficacy data. Generic options will dominate, suppressing prices.

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Summary of Market Metrics

Parameter	Data Point
Estimated global market size	>$3 billion by 2027
CAGR (2023–2027)	Approximately 5%
Branded peak revenue	~$800 million annually (pre-generic entry)
Current branded revenues	$200–$400 million
Price (pre-generic)	$9,000–$12,000/month
Price (post-generic)	$2,500–$4,000/month
Patent expiry year	2019–2020

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Key Takeaways

• Nilotinib tartrate's market has contracted with patent expiration and rising generic competition.
• The global CML market grows steadily, but branded nilotinib's revenue diminishes.
• Competitive pressure from biosimilars and emerging therapies is likely to reduce profitability further.
• Long-term prospects depend on positioning against novel treatments, especially in resistant cases.

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FAQs

1. What factors prompted the decline in nilotinib's market share?
   Patent expiry, entry of generics, and changing treatment preferences toward newer agents.

2. Are there any regulatory barriers to generic entry?
   Patent expiration primarily permits generics; biosimilars face additional approval hurdles but have entered key markets.

3. How does the efficacy of nilotinib compare to competitors?
   It is effective for CML, especially in cases intolerant to imatinib, but newer drugs may offer better safety or resistance profiles.

4. What is the outlook for ongoing branded sales?
   Branded sales are declining; future revenues depend on niche markets and resistance management.

5. What are alternative therapies impacting nilotinib’s market?
   Asciminib and other novel agents targeting resistant or intolerant CML patients.

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References

[1] MarketsandMarkets. "Chronic Myeloid Leukemia Market by Therapy (TKIs, Chemotherapy), End User (Hospitals, Clinics), Region (North America, Europe, Asia-Pacific), Forecast to 2027."
[2] FDA. "Tasigna (Nilotinib) Prescribing Information."
[3] EvaluatePharma. "Global Oncology Market Reports," 2022.
[4] IQVIA. "Market Dynamics in Oncology," 2022.
[5] Patient demographics and market estimates derived from global CML epidemiological data.