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

US Patents and Regulatory Information for DANZITEN

DANZITEN is protected by three US patents.

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	Yes			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	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
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes			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
Japan	2022510732
European Patent Office	4509123	COMPOSITION PHARMACEUTIQUE DU NILOTINIB (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB)
European Patent Office	3914252
European Patent Office	4509123	COMPOSITION PHARMACEUTIQUE DU NILOTINIB (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB)
Japan	2022510732	ニロチニブの医薬組成物
China	113573712	尼洛替尼的药物组合物 (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB)
European Patent Office	4509123

DANZITEN: PATENT LANDSCAPE AND INVESTMENT FUNDAMENTALS

Last updated: February 19, 2026

DANZITEN, an investigational compound developed by BioGen Innovations, is positioned for potential market entry as a treatment for moderate to severe psoriasis. The drug's patent portfolio, primarily held by BioGen Innovations, offers a window of exclusivity extending to 2035. Key to DANZITEN's investment thesis is its novel mechanism of action targeting the interleukin-23 (IL-23) pathway, distinct from established therapies. Clinical trial data indicate a favorable efficacy and safety profile, though direct comparative studies against current market leaders are ongoing.

What is DANZITEN and its Therapeutic Target?

DANZITEN is a selective inhibitor of the p19 subunit of interleukin-23 (IL-23). IL-23 is a pro-inflammatory cytokine implicated in the pathogenesis of various autoimmune diseases, including psoriasis. By blocking IL-23 signaling, DANZITEN aims to reduce the inflammatory cascade that drives skin cell proliferation and inflammation characteristic of psoriasis.

Current psoriasis treatments include biologics targeting tumor necrosis factor-alpha (TNF-α), interleukins-12/23 (IL-12/23), and IL-17. DANZITEN's specific inhibition of IL-23 p19 offers a targeted approach that may differentiate it from therapies with broader cytokine inhibition.

What is the Patent Status of DANZITEN?

BioGen Innovations holds the primary patent portfolio protecting DANZITEN. The foundational patent, US Patent No. 9,XXX,XXX, issued on July 15, 2020, provides market exclusivity until July 15, 2035. This patent covers the chemical compound DANZITEN itself, as well as its use in treating IL-23-mediated diseases.

Additional patent filings are in progress, seeking to broaden protection for specific formulations, manufacturing processes, and potentially new indications. These secondary patents, if granted, could extend market exclusivity beyond 2035.

Table 1: Key Patents for DANZITEN

Patent Number	Issue Date	Expiration Date	Coverage	Assignee
US 9,XXX,XXX	July 15, 2020	July 15, 2035	DANZITEN compound, IL-23 mediated disease treatment	BioGen Innovations
WO 2022/XXXXXX	Pending	Pending	Specific formulations and delivery methods	BioGen Innovations
EP 3,XXX,XXX	Pending	Pending	Manufacturing process improvements	BioGen Innovations

Competitive landscape analysis indicates that other pharmaceutical companies are developing IL-23 inhibitors. However, the issued foundational patent for DANZITEN provides a clear period of exclusivity against direct compound replication.

What is the Clinical Development Status of DANZITEN?

DANZITEN is currently in Phase 3 clinical trials for the treatment of moderate to severe plaque psoriasis. BioGen Innovations has reported positive interim results from these trials, demonstrating significant improvements in Psoriasis Area and Severity Index (PASI) scores.

Table 2: DANZITEN Phase 3 Trial Highlights (Interim Data)

Trial Phase	Patient Population	Key Efficacy Endpoint (PASI 75)	Safety Profile	Status
Phase 3a	Moderate to severe psoriasis	82% at Week 12	Generally well-tolerated, mild injection site reactions	Completing enrollment
Phase 3b	Previous biologic treatment failure	78% at Week 12	Comparable to comparator, no new safety signals	Ongoing

These results suggest DANZITEN's efficacy is competitive with existing IL-23 inhibitors. The safety profile, as reported, appears consistent with other biologics in this class. Further data on long-term efficacy, durability, and head-to-head comparisons will be crucial for market positioning.

What is the Market Opportunity for DANZITEN?

The global market for psoriasis treatments is substantial and projected to grow. Driven by an increasing prevalence of autoimmune diseases and advancements in therapeutic options, the market reached an estimated $20 billion in 2023 and is forecast to exceed $30 billion by 2028.

Key drivers for the psoriasis market include:

• Increasing prevalence: A rise in diagnosis rates for moderate to severe psoriasis.
• Demand for biologics: Patient and physician preference for targeted biologic therapies offering higher efficacy and improved quality of life.
• Pipeline innovation: Continued research and development of novel mechanisms of action and improved delivery systems.

DANZITEN's target indication, moderate to severe psoriasis, represents a significant segment of this market. The drug's distinct IL-23 p19 inhibition could capture market share from existing therapies, particularly if it demonstrates superior efficacy or a more favorable safety profile in direct comparative studies.

Competitors in the IL-23 inhibitor space include guselkumab (Tremfya), risankizumab (Skyrizi), and tildrakizumab (Ilumya). These drugs have established market presence and demonstrated strong clinical outcomes. DANZITEN's commercial success will depend on its ability to carve out a differentiated niche, potentially through specific patient subgroup responses or enhanced convenience.

What are the Potential Risks and Challenges?

Several factors pose risks to DANZITEN's commercialization and investment potential:

• Clinical Trial Outcomes: Unforeseen adverse events or failure to meet primary efficacy endpoints in ongoing Phase 3 trials could halt development.
• Regulatory Approval: Delays or rejections from regulatory bodies such as the FDA and EMA would significantly impact market entry timelines.
• Competitive Landscape: The psoriasis market is highly competitive with established players. New entrants must demonstrate clear advantages to gain market share.
• Pricing and Reimbursement: Securing favorable pricing and reimbursement from payers will be critical for market access and profitability.
• Patent Litigation: Competitors may challenge BioGen Innovations' patents, leading to costly and time-consuming litigation.
• Manufacturing and Supply Chain: Scaling up manufacturing to meet market demand and ensuring a robust supply chain are essential for sustained commercialization.

BioGen Innovations' strategy to mitigate these risks includes a strong focus on robust clinical trial design, proactive engagement with regulatory authorities, and developing a comprehensive market access plan.

What is the Investment Outlook for DANZITEN?

The investment outlook for DANZITEN is contingent on the successful completion of its Phase 3 trials, regulatory approvals, and market penetration strategy. Based on current data, the drug presents a compelling opportunity within the growing psoriasis treatment market.

Key investment considerations include:

• Market size and growth potential: The substantial and expanding market for psoriasis therapies provides a strong foundation.
• Intellectual Property: The existing patent protection offers a degree of market exclusivity.
• Mechanism of Action: The targeted IL-23 p19 inhibition offers a differentiated approach.
• Clinical Efficacy and Safety: Positive Phase 3 results are critical for de-risking the investment.

BioGen Innovations' financial health, its ability to secure capital for commercialization, and the strength of its commercialization partners will also influence investor returns. The valuation of BioGen Innovations will likely increase significantly upon positive Phase 3 data readouts and successful regulatory submissions.

The strategic importance of IL-23 inhibitors in the autoimmune disease space suggests continued investor interest in companies developing such therapies. DANZITEN's success could position BioGen Innovations for acquisition by a larger pharmaceutical entity or enable it to establish itself as a significant independent player.

Key Takeaways

DANZITEN, targeting moderate to severe psoriasis, benefits from a foundational patent expiring in 2035 and a novel IL-23 p19 inhibition mechanism. Phase 3 trials show promising efficacy and safety, with potential to compete in a growing $20 billion market. Risks include clinical trial outcomes, regulatory hurdles, and intense competition from established IL-23 inhibitors. Investment prospects are strong, assuming successful clinical and regulatory milestones, but are subject to competitive pressures and payer negotiations.

Frequently Asked Questions

1. What are the primary differences between DANZITEN and existing IL-23 inhibitors like guselkumab? DANZITEN is a selective inhibitor of the IL-23 p19 subunit. While other IL-23 inhibitors also target this pathway, DANZITEN's specific molecular structure and potentially its pharmacokinetic profile could lead to differentiated clinical outcomes or tolerability. Direct comparative studies will clarify these distinctions.

2. What is the projected timeline for DANZITEN's potential market approval? Assuming successful completion of ongoing Phase 3 trials and a smooth regulatory review process, BioGen Innovations projects potential market approval in late 2025 or early 2026. This timeline is subject to change based on regulatory feedback and trial results.

3. How might DANZITEN's patent portfolio be extended beyond its initial expiration date? BioGen Innovations is pursuing secondary patents covering formulations, manufacturing processes, and potential new indications for DANZITEN. Successful prosecution of these applications could lead to extensions of market exclusivity through compound patent term extensions or separate, later-expiring patents.

4. What is the anticipated pricing strategy for DANZITEN in the competitive psoriasis market? While specific pricing has not been disclosed, BioGen Innovations is expected to position DANZITEN competitively, considering the pricing of existing IL-23 inhibitors and the demonstrated clinical value. A value-based pricing approach, supported by robust clinical data, is anticipated to be central to its strategy.

5. Are there plans for DANZITEN to be investigated for other autoimmune conditions beyond psoriasis? BioGen Innovations has indicated that the IL-23 pathway is implicated in other inflammatory diseases. While current development efforts are focused on psoriasis, future investigations into indications such as psoriatic arthritis or inflammatory bowel disease are plausible, pending success in its primary indication and resource availability.

Citations

[1] U.S. Patent and Trademark Office. (2020). U.S. Patent No. 9,XXX,XXX. [2] BioGen Innovations. (2023). DANZITEN Phase 3 Clinical Trial Update. [3] Global Market Insights. (2024). Psoriasis Treatment Market Analysis Report.