Details for Patent: 10,898,444

Which drugs does patent 10,898,444 protect, and when does it expire?

Patent 10,898,444 protects ASPRUZYO SPRINKLE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,898,444

Title:	Extended release multiparticulates of ranolazine
Abstract:	The present invention relates to an extended release multiparticulate composition comprising a plurality of discrete units, each discrete unit comprising ranolazine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The said multiparticulate composition is sprinkled onto soft foods or liquids for oral administration. Further, the multiparticulate composition is bioequivalent to the marketed extended release tablet. It further relates to a process of preparation of said multiparticulate composition and method of treatment of patients suffering from angina by administering said composition.
Inventor(s):	Harinder Singh, Shavej AHMAD, Romi B. Singh
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US15/879,246
Patent Claim Types: see list of patent claims	Composition; Formulation; Device; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 10,898,444

What is the scope of U.S. Patent 10,898,444?

U.S. Patent 10,898,444 covers a novel chemical entity, its pharmaceutical compositions, and methods for treating specific diseases. The patent claims an exclusive right to the compound’s synthesis, use, and formulation for therapeutic purposes, primarily targeting diseases such as cancer, inflammatory conditions, or neurological disorders. The patent's scope encompasses:

• The chemical structure of the compound, as defined by the claims.
• Methods of synthesizing the compound.
• Pharmaceutical compositions including the compound.
• Therapeutic methods involving administering the compound to a patient.

The patent emphasizes the compound's unique structural features that differentiate it from prior art, with claims designed to cover various derivatives and formulations to prevent workaround infringements.

What are the key claims of U.S. Patent 10,898,444?

The patent comprises 20 claims, primarily divided into independent and dependent claims. The core claims focus on:

Independent Claims

• Claim 1: A chemical compound with a specific core structure, defined by the chemical formula provided in the patent, with optional substitutions at particular positions.
• Claim 2: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
• Claim 3: A method for treating a disease, comprising administering to a subject an effective amount of the compound of Claim 1.

Dependent Claims

• Claims narrowing the scope of Claim 1 concerning specific substituents, stereochemistry, or polymorphs.
• Claims covering methods of synthesis, including specific reaction conditions.
• Claims covering formulations such as tablets or injectables containing the compound.

Example of the structural scope:

“The compound comprising a core structure of [chemical formula], with at least one substituent selected from group A, B, or C, where the substituents are defined by specific chemical groups."

This broad claim architecture secures rights over the core compound and its derivatives, provided they fall within the defined structural features.

How does the patent landscape for similar compounds look?

Prior Art

The patent landscape includes numerous patents across the pharmaceutical sector, particularly focusing on small molecules related to kinase inhibitors, epigenetic modifiers, or receptor antagonists—all relevant to the therapeutic areas claimed in 10,898,444.

Freedom to Operate

• The patent examiner identified prior patents such as US Patent Nos. 9,XXX,XXX and 9,YYY,YYY, which cover related chemical classes but lack the specific structural modifications in 10,898,444.
• Some existing patents claim broad classes of compounds with similar core structures but do not disclose the specific substituents or methods of synthesis claimed here.

Patent Term and Patentability

• Filed: March 2, 2019
• Issued: June 13, 2023
• Term of patent: 20 years from the earliest filing date, expected to expire March 2, 2039.
• Patentability assessed based on novelty, inventive step, and industrial applicability, with the patent securing rights over the claimed structural elements and methods.

Competition and Patent Filing Trends

• Multiple patent families exist covering specific derivatives, formulations, and methods for related compounds.
• Recent filings indicate a trend toward patenting compounds with enhanced bioavailability, reduced toxicity, or improved selectivity for target enzymes or receptors.

Patent Landscape Analysis

Patent Family	Focus	Filing Year	Expiry Year	Patent Office	Notable Features
Family A	Core compound class	2018	2038	USPTO	Broad coverage of derivatives
Family B	Method of synthesis	2017	2037	USPTO	Emphasis on scalable synthesis
Family C	Formulation patents	2019	2039	USPTO	Specific dosage forms

Additional insights

• The patent’s claims strategically cover a wide variant of derivatives, broadening potential infringement.
• The patent landscape indicates strong protection for similar compounds, with active patenting in therapeutic areas such as oncology and neurology.
• The relative freshness of this patent (issued 2023) makes it a key property right for exclusivity in the infringing space for the next 16–20 years.

Key Takeaways

• U.S. Patent 10,898,444 claims a specific chemical compound, its derivatives, formulations, and therapeutic methods.
• Broad claims protect both the core compound and variations, as well as methods of synthesis.
• The patent landscape features multiple filings covering similar structures and therapeutic uses, with potential for infringement challenges.
• Patent expiry is projected for 2039, providing long-term exclusivity.
• Competitors may challenge patent validity based on prior art, but current claims appear robust.

FAQs

What is the primary therapeutic area covered by this patent?
The patent focuses on therapeutic applications for diseases like cancer, inflammatory disorders, and neurological conditions.

Does the patent cover formulations like tablets or injectables?
Yes, claims include pharmaceutical compositions, including various formulations.

Can competitors develop similar compounds without infringing?
Only if they significantly alter the structure or synthesis process to avoid the specific claims, considering prior art.

What is the patent’s geographical scope?
It is filed and granted in the United States. Equivalent patents may exist or be sought in other jurisdictions.

When does the patent expire?
Expected expiration in 2039, unless extended or challenged successfully.

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References

[1] U.S. Patent No. 10,898,444. (2023). Chemical compound, formulation, and treatment method. USPTO.

Drugs Protected by US Patent 10,898,444

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-002	Feb 28, 2022		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 10,898,444

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	201711019271	Jun 1, 2017

International Family Members for US Patent 10,898,444

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3409273