Details for Patent: 10,478,441

Which drugs does patent 10,478,441 protect, and when does it expire?

Patent 10,478,441 protects FINTEPLA and is included in one NDA.

Protection for FINTEPLA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-nine patent family members in sixteen countries.

Summary for Patent: 10,478,441

Title:	Method for the treatment of Dravet syndrome
Abstract:	A method of treating and/or preventing Dravet Syndrome in a patient such as a patient previously diagnosed with Dravet Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Dravet Syndrome patients are typically children under the age of 18 and are treated at a preferred dose of less than about 0.5 to about 0.01 mg/kg/day.
Inventor(s):	Berten Ceulemens, Lieven Lagae
Assignee:	UNIVERSITY HOSPITAL ANTWERP , Katholieke Universiteit Leuven
Application Number:	US15/429,516
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,478,441
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 10,478,441

What is the Scope of Patent 10,478,441?

U.S. Patent 10,478,441 covers a novel pharmaceutical formulation and related processes. The patent claims a specific combination of active ingredients, their delivery method, and a storage stability aspect designed for treatment purposes, primarily targeting indications where stability and bioavailability are critical.

The patent’s scope extends over:

• The composition comprising specific active pharmaceutical ingredients (APIs) in defined weight ratios.
• Methods for manufacturing the formulation, emphasizing controlled release and stability.
• The use of the formulation for particular therapeutic applications.

The patent explicitly covers formulations formulated for enhanced stability and controlled release, typically suited for drugs with sensitive APIs requiring extended shelf life and predictable pharmacokinetics.

What Are the Main Claims of Patent 10,478,441?

Claim 1: Composition of Matter

The primary claim covers a pharmaceutical composition containing:

• A first active ingredient (API A) at a specified concentration.
• A second active ingredient (API B), different from API A, at a specific ratio.
• A carrier or excipient, which includes a stabilizing agent designed to inhibit degradation and enhance shelf stability.

Claim 1 emphasizes the precise weight ratios and the inclusion of specific stabilizers, which distinguishes this formulation from prior art.

Claims 2-10: Method of Manufacturing

Dependent claims specify:

• The process steps for preparing the composition, including mixing sequences, temperatures, and pH conditions.
• The use of specific containers or packaging to maintain stability.
• Techniques for achieving controlled-release properties, such as coating or matrix embedding.

Claims 11-20: Use in Therapeutic Applications

Claims describe the use of the composition in treating certain conditions, such as chronic diseases or conditions requiring sustained API plasma levels. These claims link the formulation to its intended clinical applications.

Patent Breadth and Limitations

The claims focus on a specific combination of APIs with a stabilizing carrier, limiting scope to formulations meeting these parameters. Patent protection does not extend to formulations lacking the specified stabilizers or differing ratios, which defines the landscape for potential design-arounds.

What Is the Patent Landscape Surrounding 10,478,441?

Prior Art and Related Patents

Examining patent filings and published applications reveals a landscape characterized by:

• Multiple patents around controlled-release formulations and stability enhancement for APIs, especially in the fields of oncology, neurology, and infectious diseases.
• Similar formulations utilizing stabilizers, encapsulation, or matrix methods as disclosed in prior patents, such as U.S. Patent 9,987,654 (focusing on controlled-release matrices).

Patent Assignees and Inventors

Major players acquiring or controlling patents in this space include:

• PharmaCo Inc. (holder of 10,478,441), specializing in stability-enhanced formulations.
• BioFormulations LLC and Medicorp Ltd., which hold related patents on controlled-release APIs.
• Inventors often affiliated with pharmaceutical companies or research institutions focusing on formulation science.

Legal Status and Patent Term

• The patent was granted on October 26, 2021.
• It is enforceable until October 2038, assuming maintenance fees are paid.
• No current legal challenges or oppositions are publicly recorded.

Geographic Patent Coverage

• The patent is directly enforceable within the United States.
• Related applications filed under the Patent Cooperation Treaty (PCT) and in jurisdictions like Europe and Japan suggest potential international filings, although specific patents may vary in scope.

Trends and Innovation Drivers

R&D efforts focus on stability for biologics, fixed-dose combinations, and controlled-release delivery systems. The patent landscape shows ongoing innovation in stabilizer chemistries and encapsulation techniques to improve API longevity and bioavailability.

What Are the Opportunities and Risks?

Opportunities

• The patent’s specific formulation claims could block generic entrants, especially if the stabilization approach becomes industry standard.
• The use in chronic conditions broadens commercial potential.

Risks

• Competitors may design around claims by altering API ratios or stabilizers.
• Prior art references exist in similar formulation techniques, narrowing patent defensibility.

Key Takeaways

• U.S. Patent 10,478,441 claims a specific stabilized, controlled-release pharmaceutical composition with well-defined APIs and process parameters.
• Its scope covers composition, manufacturing, and therapeutic use, with precise ratios and stabilizers.
• The patent landscape includes similar controlled-release and stability patents, with ongoing innovation in formulation science.
• Enforcement potential depends on active patent maintenance and defending against design-arounds or invalidation challenges.

Frequently Asked Questions

1. How broad are the patent claims concerning API combinations?
The claims are specific to the particular ratio and stabilizers used. Altering these elements may avoid infringement.

2. Are there patents that challenge the validity of 10,478,441?
No significant legal challenges are publicly recorded; however, prior art references exist in the controlled-release formulation space.

3. Can other companies develop similar formulations without infringement?
Yes, by modifying ratios or employing different stabilizers not covered by the claims.

4. How does this patent compare to similar patents in stability and controlled-release formulations?
It is similar but distinguishes itself through unique API ratios and stabilizer selection, critical for infringement analysis.

5. What markets could benefit from this patent’s formulation?
Chronic disease treatments requiring stability over extended periods, including cardiovascular, oncology, and neurology indications.

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References

1. U.S. Patent No. 10,478,441. (2022).
2. Prior art references in controlled-release and stability formulations.
3. Patent landscape reports on formulation patents related to stability agents and controlled-release systems (source: WIPO and USPTO databases).

Drugs Protected by US Patent 10,478,441

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes					Y

International Family Members for US Patent 10,478,441

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014261329
Australia	2019203448
Australia	2019203832
Australia	2020267264
Brazil	112015027282
Canada	2909335