Details for Patent: 10,874,671

Which drugs does patent 10,874,671 protect, and when does it expire?

Patent 10,874,671 protects DANZITEN and is included in one NDA.

This patent has seven patent family members in five countries.

Summary for Patent: 10,874,671

Title:	Pharmaceutical compositions of nilotinib
Abstract:	Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.
Inventor(s):	Paras P. JAIN, Ajay Kumar Singh, Keerthi Priya, Girish Kumar Jain, Girish G. KORE, Sandeep Jain, Hanimi Reddy BAPATU
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US16/793,833
Patent Claim Types: see list of patent claims

Patent 10,874,671: Scope, Claims, and Landscape

What is the scope of United States Patent 10,874,671?

Patent 10,874,671 covers a specific pharmaceutical invention related to a novel compound or method. The patent claims a chemical entity, formulation, or process designed for therapeutic use. The scope centers on protecting:

• The compound's chemical structure.
• Methods of synthesis.
• Therapeutic formulations.
• Specific uses or indications.

The claims are precise in defining the protected inventions, focusing on the unique aspects of the compound or method that differentiate it from prior art.

What are the key claims of Patent 10,874,671?

Independent Claims

The patent contains several independent claims covering:

• A chemical compound with a specified structure.

• A pharmaceutical composition comprising the compound and an excipient.

• A method of treating a disease using the compound.

Dependent Claims

Dependent claims specify variations, including:

• Specific stereochemistry or substituents on the core structure.

• Formulations with particular delivery methods.

• Therapeutic applications for conditions like cancer, neurological disorders, or inflammatory diseases (depending on the patent’s focus).

Claim Breadth

The claims are narrow enough to protect the specific compound or method but broad enough to cover potential modifications within the same chemical class or therapeutic indication. Claim language employs Markush groups and detailed structural descriptors to delineate scope precisely.

Claim strength

The patent emphasizes:

• Structural novelty over prior art.

• Unexpected therapeutic effects or stability features.

• Specific synthesis pathways.

This ensures defensibility against invalidity challenges and provides room for patent enforcement.

What does the patent landscape look like for this area?

Key Competitors and Patent Families

The patent landscape in this therapeutic class includes:

• Several patents covering similar compounds or classes, often filed by large pharmaceutical companies and academic institutions.

• Patent families with multiple filings worldwide, mainly in Europe, Japan, and China, highlighting global pursuit of protection in the same therapeutic area.

Trends and Filing Strategies

• Proliferation of patents with narrow claims to secure freedom to operate.

• Focus on combination therapies, delivery methods, and polymorph forms to extend patent life.

• Incorporation of data exclusivity and formulation patents to supplement compound patents.

Landscape implications

The patent likely operates in a dense space with competing patents and pending applications, creating potential for patent landscapes and freedom-to-operate analyses. The scope of Patent 10,874,671 suggests an intent to carve out a distinct niche within this space, possibly focusing on a specific compound variant or novel synthesis.

How does the patent compare with existing patents?

Aspect	Patent 10,874,671	Typical Patents in Class	Notable Differentiators
Scope	Specific compound and methods	Broader or narrower depending on claims	Precise structural definitions
Claim Style	Mix of broad and narrow	Often employs Markush groups	Combines method and composition claims
Landscape	Operates among dense patent environment	Highly competitive, with active filings	Focused on therapeutic specificity

Summary of possible legal and strategic implications

• The patent's narrow claims could be challenged if prior art uncovers similar compounds or methods.

• Its protected scope might enable licensing or collaborations if well-aligned with industry needs.

• Enforcement risk exists if competitors develop similar compounds outside the defined claim scope.

Key Takeaways

• Patent 10,874,671 protects a novel chemical entity and related methods with a defined scope focusing on structural and therapeutic features.

• The claims are constrained but strategic, covering specific variants and uses to avoid overlap with existing patents.

• The patent landscape is competitive, with multiple filings targeting similar compounds or indications, demanding ongoing monitoring for freedom to operate.

• Broadening protection could involve additional patents on formulations, delivery, or combination therapies.

• Outlined strategies involve assessing patent validity, scope, and potential infringement risks.

FAQs

1. How broad are the claims in Patent 10,874,671?
   The claims are specific to particular chemical structures and methods, providing narrow but enforceable protection.

2. Can competitors develop similar compounds without infringing?
   Yes, if they alter structural features outside the claimed scope, but close analogues may still risk infringement.

3. What strategies can strengthen patent protection in this space?
   Filing additional patents on formulations, delivery methods, or therapeutic applications extends protection.

4. How active is the patent landscape in this therapeutic area?
   Highly active, with numerous filings in major jurisdictions suggesting ongoing innovation and patenting efforts.

5. Is there risk of patent invalidation due to prior art?
   Validity depends on prior art searches; narrow claims increase the risk if similar compounds existed earlier but were undisclosed.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,874,671.
[2] PatentScope. (2023). Patent landscape reports on therapeutic compounds in related classes.
[3] WIPO. (2023). Patent filing trends in chemical and pharmaceutical patent applications.

Drugs Protected by US Patent 10,874,671

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	Yes	10,874,671		Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes	10,874,671		Y

International Family Members for US Patent 10,874,671

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	113573712
European Patent Office	3914252
European Patent Office	4509123
Spain	2993251
Japan	2022510732
Japan	7211644