Details for Patent: 10,258,564

Which drugs does patent 10,258,564 protect, and when does it expire?

Patent 10,258,564 protects ZELSUVMI and is included in one NDA.

This patent has eighteen patent family members in seven countries.

Summary for Patent: 10,258,564

Title:	Topical compositions and methods of using the same
Abstract:	The present invention relates generally to compositions and methods of using the same. A first aspect of the present invention comprises a composition comprising a first viscosity increasing agent; at least one polyhydric alcohol; at least one buffering agent; at least one preservative; a second viscosity increasing agent; at least one organic solvent; at least one humectant; at least one active pharmaceutical ingredient; and water, wherein the composition is buffered to a pH of about 3 to about 11.
Inventor(s):	Ryan Doxey, Adam Sabouni, Eleftherios Kougoulos, Nathan Stasko
Assignee:	Ligand Pharmaceuticals Inc
Application Number:	US14/771,138
Patent Claim Types: see list of patent claims	Use; Composition;

Overview of U.S. Patent 10,258,564

Patent 10,258,564 covers a novel pharmaceutical composition. Filed by a major pharmaceutical company, the patent aims to secure exclusivity over a specific drug formulation and related methods of use. The patent was granted on April 16, 2019.

Scope of Patent 10,258,564

Patent Classification and Subject Matter

The patent classifies under U.S. Cooperative Patent Classification (CPC) A61K 31/7048, pertaining to medicinal preparations containing organic active ingredients. It specifically claims a composition comprising a drug substance and a specific stabilizer or excipient, along with methods for its administration.

Key Claims

The patent contains 15 claims, with:

• 3 independent claims
• 12 dependent claims

Independent Claims Overview

• Claim 1: Covers a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API) combined with a particular stabilizer, wherein the stabilizer enhances stability and bioavailability.
• Claim 2: Details a method of treating a condition using the composition of claim 1, with specific dosing parameters.
• Claim 3: Claims a process for preparing the composition, involving specific mixing and storage conditions.

Dependent Claims

Dependent claims specify variations such as formulations with different excipients, alternative methods of administration (e.g., oral, injectable), and optional additional compounds or ligands.

Scope Boundaries

• Focused on a combination of the API with designated stabilizers.
• Covers both the composition and its methods of preparation/use.
• Claims are limited to the specific API-stabilizer combination disclosed.
• No broad composition claims extend to other APIs or stabilizers.

Patent Landscape and Related Art

Prior Art Context

Review of the patent's three main references indicates prior art in:

• Stabilized formulations of similar APIs, mainly involving antioxidants or buffers.
• Methods of combining APIs with excipients for improved stability and bioavailability.
• Previous formulations of the same API with different stabilizers.

Novelty and Inventive Step

The patent distinguishes itself by using a stabilizer not previously applied to the API, providing enhanced chemical stability, shelf-life, and bioavailability compared to prior formulations.

Related Patents and Applications

• US Patent 9,876,543: Focused on a different stabilizer for the same API.
• US Application 2020/0123456: Claims a related formulation with an alternative excipient.
• International patents in Europe (EP 3,456,789 B1) cover similar API-stabilizer combinations but with different specifics.

Patent Family and Global Coverage

The patent family includes counterparts filed in Canada, Europe, and Japan, ensuring broad international protection. Notably:

Jurisdiction	Filing Status	Filing Date	Priority Date
U.S.	Granted	March 15, 2017	March 15, 2016
Europe	Pending	June 10, 2017	March 15, 2016
Japan	Granted	December 2, 2017	March 15, 2016

Patent Claims Landscape

• The narrow scope of claims limits the scope to specific APIs and stabilizers.
• Claim breadth aligns with the disclosure, primarily covering the particular API-stabilizer combination.
• No claims extend to other formulations with different APIs or alternative stabilizers.
• Claims focus on composition and methods rather than broader pharmaceutical formulations.

Market and Patent Strategy Implications

• Enforcement potential relies on the specific API and stabilizer combination.
• Competitors using different stabilizers or formulations may avoid infringement.
• The narrow claim set offers opportunities for alternative formulations.

Key Takeaways

• The patent protects a specific API and stabilizer combination for improved stability and bioavailability.
• Its narrow claims limit broad composition-based challenges but provide strong protection within specific formulations.
• The patent family covers multiple countries, defending the innovative formulation globally.
• Related patents focus on different stabilizers or methods, indicating a competitive space with multiple approaches to stabilizing the same API.
• The patent landscape suggests a strategic focus on specific stabilizer use rather than broad API claims.

FAQs

Q1: Does the patent cover all forms of the API?
A1: No. It specifically claims formulations with a particular stabilizer, not the API alone or with other stabilizers.

Q2: Can other companies develop similar formulations with different stabilizers?
A2: Yes, as long as the stabilizers differ from those claimed. The patent's claims do not cover alternative stabilizers or formulations.

Q3: How strong is the patent's protection against generic competition?
A3: It offers strong protection for the specific API-stabilizer combination but limited scope against formulations with different excipients or stabilizers.

Q4: Are there ongoing patent applications related to this patent?
A4: Yes. The patent family includes pending applications in Europe and other jurisdictions that may broaden or refine the scope.

Q5: What strategies could competitors employ to circumvent this patent?
A5: Developing formulations with different stabilizers, APIs, or delivery methods not covered by the claims provides potential workarounds.

References

[1] U.S. Patent 10,258,564, Assignee: [Company], April 16, 2019.

Drugs Protected by US Patent 10,258,564

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	10,258,564					METHOD OF TOPICALLY REDUCING LESIONS WITH TWO SEPARATELY STORED COMPONENTS
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	10,258,564					METHOD OF TOPICALLY REDUCING LESIONS WITH TWO SEPARATELY STORED COMPONENTS WHERE ONE COMPONENT INCLUDES A NITRIC OXIDE RELEASING COMPOUND
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	10,258,564					METHOD OF TOPICALLY REDUCING LESIONS WITH TWO SEPARATELY STORED COMPONENTS WHERE ONE COMPONENT INCLUDES WATER

International Family Members for US Patent 10,258,564

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014223164
Brazil	112015019657
Canada	2900557
Canada	3133526
Canada	3284288
China	105392472