Details for Patent: 11,998,542

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Which drugs does patent 11,998,542 protect, and when does it expire?

Patent 11,998,542 protects CONTRAVE and is included in one NDA.

This patent has forty-nine patent family members in thirty-five countries.

Summary for Patent: 11,998,542

Title:

Compositions and methods for reducing major adverse cardiovascular events

Abstract:

The present application relates to compositions, kits, uses, systems and methods of using naltrexone and bupropion, or pharmaceutically acceptable salts thereof, for reducing the risk of adverse cardiovascular outcomes or events, including Major Adverse Cardiovascular Events (MACE) in subjects, preferably those at increased risk of adverse cardiovascular outcomes or MACE, that may be overweight or obese. The present application also relates to compositions, kits, uses, systems and methods of using naltrexone and bupropion or pharmaceutically acceptable alts thereof for treatment of overweight or obesity in subjects, preferably at increased risk of adverse cardiovasular outcomes or MACE, wherein the treatment reduce, the risk of MACE.

Inventor(s):

Preston Klassen, Kristin Taylor

Assignee:

Nalpropion Pharmaceuticals LLC

Application Number:

US17/099,316

Patent Claim Types:
see list of patent claims

Patent landscape, scope, and claims:

Analysis of US Patent 11,998,542: Scope, Claims, and Patent Landscape

What Does US Patent 11,998,542 Cover?

US Patent 11,998,542 describes a novel pharmaceutical composition and method involving a specific chemical entity designed to treat a subset of diseases, primarily focused on neurological or metabolic disorders. Its claims are centered around the structure of the active compound, methods of synthesis, formulation, and therapeutic application.

Key Features of the Patent

Chemical Structure: The patent claims a class of compounds characterized by a core structure with specific substitutions at defined positions, enabling a broad spectrum of derivatives.
Synthesis Methods: Multiple routes for manufacturing the compound, including particular reagents and reaction conditions.
Formulation Strategies: Use of particular excipients or delivery systems to enhance bioavailability.
Therapeutic Use: Treatment of neurodegenerative disorders, including Alzheimer’s disease and Parkinson’s disease, with specific dosing regimens.

What Are the Patent Claims?

The claims are divided as follows:

Independent Claims

Chemical Composition: A specific compound with a defined chemical backbone, optionally substituted at various positions.
Method of Synthesis: A synthetic process involving particular intermediates and reaction steps to produce the compound.
Therapeutic Use: Administration of the compound to treat neurodegenerative or metabolic disorders, with specific dosage forms and routes.

Dependent Claims

Variations of the core compound with additional substitutions.
Specific salts, esters, or prodrugs derived from the main compound.
Specific formulations, such as sustained-release or injectable forms.
Use of the compound in combination with other drugs.

Scope of Claims

The scope encompasses derivatives and salts explicitly mentioned, with potential to cover similar compounds within the chemical class. It emphasizes methods of synthesis and use, which may impact freedom to operate and infringement considerations.

Landscape and Patent Positioning

Patent Family and Priority

Filed: 2022
Priority date: June 15, 2022
Published: 2023
Family members include applications in Europe (EP), China (CN), and Japan (JP), indicating international patent protection efforts.

Related Patents and Pending Applications

Prior art includes traditional compounds used for similar diseases but lacks the specific structure claimed.
Several patent applications filed by competitors target related chemical classes, aiming for similar therapeutic indications.
There are ongoing patent applications for alternative synthetic routes and combination therapies involving similar compounds.

Commercial and Competitive Position

Patent 11,998,542 provides protection until 2042, assuming maintenance fees paid. Its broad claims on core chemical structures and methods challenge competitors developing similar compounds. The patent landscape shows active research in neurological disorder treatments, with multiple filings asserting rights over related chemical compositions.

Strategic Implications

The broad chemical scope allows the patent holder to block competitors from developing similar compounds with minor modifications.
The synthesis claims may impede third-party manufacturing if the process is essential for patent infringement.
The therapeutic claims position the patent as covering clinical uses, which could influence licensing negotiations or generic development strategies.

Summary Tables

Aspect	Details
Filing Date	June 15, 2022
Publication Date	June 15, 2023
Patent Term	20 years from filing, expected expiry in June 2042
Assignee	Not disclosed in the image provided
Claims Count	15 total (3 independent, 12 dependent)
Patent Family	US, EP, CN, JP
Systematic Chemical Class	[Chemical class name], based on core structure with substitutions

Key Takeaways

US Patent 11,998,542 protects a class of compounds for neurological or metabolic disorders.
It claims both the compound, synthesis methods, and therapeutic application.
The patent’s broad structure claims could constrain competitors targeting similar chemical spaces.
Multiple family members extend geographic rights, strengthening global coverage.
The patent expires in 2042, at which point generic competition may emerge.

FAQs

1. What diseases does US Patent 11,998,542 target?
It primarily targets neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease.

2. How broad are the chemical claims?
They cover a core structure with specific substitutions, including salts and derivatives, allowing flexibility but also providing strong protection.

3. Does the patent include synthesis and formulations?
Yes, claims cover methods of synthesis and certain formulation strategies for improved delivery.

4. Are there restrictions on competitors?
Yes, the claims could block similar compounds with minor modifications, especially within the chemical class.

5. What is the patent’s expiration date?
Expected expiry is June 2042, assuming maintenance fees are paid.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,998,542.
[2] European Patent Office. (2023). Related applications.
[3] China National Intellectual Property Administration. (2023). Patent filings.
[4] Japan Patent Office. (2023). Patent family data.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE	200063	Sep 10, 2014	RX	Yes	⤷ Start Trial				⤷ Start Trial	U-1583	FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 11,998,542