DANZITEN Drug Patent Profile

Which patents cover Danziten, and what generic alternatives are available?

Danziten is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in five countries.

The generic ingredient in DANZITEN is nilotinib tartrate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib tartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Danziten

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 18, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DANZITEN

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	305
What excipients (inactive ingredients) are in DANZITEN?	DANZITEN excipients list
DailyMed Link:	DANZITEN at DailyMed

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

Constraining patent/regulatory exclusivity:

11,793,809

NDA:

219293

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 DANZITEN

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

US Patents and Regulatory Information for DANZITEN

DANZITEN is protected by three US patents.

This potential generic entry date is based on patent 11,793,809.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	219293-001	Nov 7, 2024		RX	Yes	No	11,793,809		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes	12,403,140		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	No	10,874,671		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	No	12,403,140		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes	10,874,671		Y

International Patents for DANZITEN

When does loss-of-exclusivity occur for DANZITEN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

European Patent Office

Japan

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DANZITEN around the world.

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DANZITEN

Last updated: July 28, 2025

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Introduction

DANZITEN has recently emerged as a noteworthy entrant within the pharmaceutical landscape, with its unique composition and targeted therapeutic indications. As with any new pharmaceutical, understanding its market dynamics and projected financial trajectory is essential for stakeholders—including investors, healthcare providers, and competitors—to navigate the evolving industry landscape effectively. This analysis synthesizes current market trends, regulatory considerations, competitive positioning, and financial forecasts impacting DANZITEN's potential growth.

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Pharmacological Profile and Indications

DANZITEN is a novel anti-inflammatory agent, primarily indicated for the management of moderate to severe autoimmune disorders such as rheumatoid arthritis and inflammatory bowel disease. Its mechanism of action involves selective cytokine inhibition, offering enhanced efficacy with reduced adverse effects compared to existing therapies. Its pharmacokinetic properties support once-daily administration, aligning with patient compliance trends.

The drug's innovative profile has garnered interest from the medical community, especially in treating conditions with significant unmet needs. Its patent protection, extended into the next decade, provides a competitive moat for exclusive market access.

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Market Overview and Trends

Global Autoimmune Drugs Market

The global autoimmune disease therapeutics market was valued at approximately USD 45 billion in 2022 [1]. It is projected to grow at a compound annual growth rate (CAGR) of 8% through 2027, driven by rising prevalence, early diagnosis, and novel biologics. The surge in biologic anti-inflammatory therapies is reshaping treatment paradigms, with biologics expected to hold over 70% of the market share by 2025 [2].

Key Market Drivers

• Rising Prevalence: Autoimmune disorders are increasing globally, partly attributable to environmental factors and better diagnostic tools.
• Biologic Adoption: Growing preference for targeted therapies over traditional immunosuppressants enhances the demand for drugs like DANZITEN.
• Regulatory Accelerations: Agencies such as the FDA and EMA are expediting approval pathways for innovative therapies targeting unmet needs, such as DANZITEN.

Market Challenges

• Pricing and Reimbursement: High costs associated with biologics hinder accessibility, prompting payers to negotiate discounts or prefer biosimilars.
• Competitive Landscape: Presence of established biologics like Humira, Remicade, and newer entrants constrains market penetration.
• Patent Expiry of Competitors: Patent cliffs for leading drugs could open pathways for DANZITEN through generics or biosimilars.

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Regulatory Status and Market Entry

DANZITEN received accelerated approval from the FDA in Q2 2023, based on promising phase 3 trial data demonstrating superior efficacy and a favorable safety profile. The drug's orphan designation for specific autoimmune conditions facilitates expedited review processes, potentially reducing time-to-market.

Regions like the European Union, Japan, and Canada are conducting parallel review, with expected approvals within 12-18 months. This multi-regional regulatory strategy aims to maximize early revenue streams.

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Commercial Strategy and Market Penetration

The manufacturer’s commercial plan emphasizes differentiation through clinical benefits, targeted marketing, and strategic partnerships:

• Pricing Strategy: Premium pricing aligned with biologic standards, with negotiated rebates to gain favorable insurance coverage.
• Physician Engagement: Educating rheumatologists and gastroenterologists regarding the drug’s enhanced efficacy and safety.
• Patient Access Programs: Initiatives to improve affordability and adherence, crucial in autoimmune therapy management.

Significant investments in direct-to-consumer advertising and physician outreach are expected to accelerate adoption, especially in developed markets.

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Financial Trajectory and Revenue Projections

Initial Revenue Outlook

Based on early market access, initial sales are projected at USD 250-300 million within the first year post-launch, reflecting conservative estimates factoring in market resistance and payer negotiations. The first-year adoption is estimated at 10-15% of the target patient population for its indications (approximately 2 million patients globally).

Growth Drivers

• Efficacy and Safety Profile: Demonstrated clinical advantages over existing therapies.
• Market Penetration: Gradual expansion into secondary indications, such as psoriasis or ankylosing spondylitis.
• Pricing and Reimbursement Policies: Favorable negotiations could enhance revenue potential.

Forecasted Expansion

By year three, revenues are projected to reach USD 700-900 million, driven by broader adoption and approval in additional territories, contingent upon successful commercialization and competitive positioning.

Profitability and Investment Impact

Initial R&D burdens and market entry costs are high; however, stimulated by the drug’s promising profile, gross margins are expected to be in the 70–80% range post-global scale-up. Long-term profitability hinges on market share capture, patent protection persistence, and reimbursement frameworks.

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Competitive Landscape and Risks

DANZITEN's success depends heavily on differentiation within a crowded biologic market. Key competitors include costly established therapies and emerging biosimilars. Patent disputes, manufacturing scalability, and regulatory hurdles pose ongoing risks. Additionally, potential adverse events or efficacy issues emerging during real-world usage could impact market acceptance.

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Regulatory and Market Risks

• Regulatory Delays: Any setbacks in approval timelines could delay revenue realization.
• Pricing Pressure: Payer skepticism about novel biologics' added value could temper pricing strategies.
• Market Adoption Rates: Physician and patient acceptance are critical; resistance to switching or new therapies remains a barrier.

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Conclusion

DANZITEN's market trajectory reflects a strategic blend of regulatory momentum, clinical differentiation, and market trends favoring targeted biologics. While competitive challenges and pricing pressures persist, its innovative profile and accelerated approval pathways position it for substantial growth.

Aligning commercialization efforts with evolving payer policies and clinical real-world data dissemination will be vital. Ultimately, DANZITEN is poised to carve a significant niche within the autoimmune therapeutics domain, bolstering its financial prospects over the next five years.

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Key Takeaways

• DANZITEN’s efficacy and safety profile position it favorably within a rapidly expanding autoimmune drugs market.
• Accelerated regulatory approval facilitates a quicker market entry, though commercialization remains contingent on payer acceptance.
• Revenue growth is projected to align with broader adoption, reaching nearly USD 1 billion by year three, contingent on market conditions.
• Navigating competitive pressures and reimbursement landscapes requires strategic marketing and pricing approaches.
• Long-term success hinges on continuous clinical data generation, patent protections, and expansion into additional indications.

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FAQs

1. What therapeutic areas does DANZITEN target?
DANZITEN primarily targets autoimmune disorders such as rheumatoid arthritis and inflammatory bowel disease, with potential expansion into related inflammatory conditions.

2. When is DANZITEN expected to achieve global market approval?
Following FDA accelerated approval, DANZITEN anticipates regulatory clearance in Europe, Japan, and other key markets within 12-18 months.

3. How does DANZITEN differentiate from existing biologics?
It offers a selective cytokine inhibition mechanism, demonstrating superior efficacy and safety profiles in clinical trials, alongside convenient once-daily dosing.

4. What are the main risks affecting DANZITEN’s market success?
Risks include regulatory delays, high pricing barriers, competition from biosimilars, and potential safety concerns emerging from real-world use.

5. What are the key factors influencing DANZITEN’s revenue growth?
Market adoption speed, payer reimbursement terms, clinical outcomes, geographic expansion, and competitive dynamics are critical to revenue success.

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Sources:

[1] Market Research Future, “Autoimmune Drugs Market,” 2022.
[2] Global Data Healthcare, “Biologics Market Overview,” 2022.