Details for Patent: 10,512,657

Which drugs does patent 10,512,657 protect, and when does it expire?

Patent 10,512,657 protects LIVMARLI and is included in two NDAs.

This patent has seventy-seven patent family members in twenty-two countries.

Summary for Patent: 10,512,657

Title:	Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Abstract:	Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.
Inventor(s):	Bronislava Gedulin, Michael Grey, Niall O'Donnell
Assignee:	Lumena Pharmaceutials LLC , Shire Human Genetics Therapies Inc
Application Number:	US15/137,323
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,512,657
Patent Claim Types: see list of patent claims

Summary:
U.S. Patent 10,512,657 (issued November 26, 2019) covers a specific formulation or method related to a particular drug candidate or therapeutic application. Its scope and claims define the innovative aspects of the invention and influence the patent landscape's dynamics.

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What Is the Scope of U.S. Patent 10,512,657?

Patent Coverage Overview

This patent primarily claims a novel pharmaceutical composition, process, or use involving a specific compound or combination. Its claims specify the composition's structural elements, dosage form, or method of administration. The scope is limited by the language of independent claims, with dependent claims refining specific embodiments.

Key Claims Summary

• Claim 1: Likely a primary apparatus, method, or compound identifier.
• Dependent Claims: Detail specific variants, such as salt forms, delivery mechanisms, or treatment methods.

Primary focus:
The patent emphasizes the unique features of its formulation or use, such as a new chemical entity, a novel adjuvant combination, or a specific therapeutic method. The scope excludes prior art by specifying structural or procedural features not present in earlier patents.

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How Do the Claims Define the Patent’s Boundaries?

Claim Language and Limitations

The claims are written in broad language that aims to cover all possible variations of the core invention, yet specific enough to distinguish from prior art.

For example:

• Claims may specify the chemical structure with particular substituents.
• They may describe a dosage range or administration route, such as oral or IV.
• Use of specific excipients or delivery systems may be claimed.

Examination of Possible Claim Types

• Product-by-Process Claims: Cover specific formulations produced via the disclosed process.
• Use Claims: Cover methods for treating specific diseases with the claimed compound.
• Formulation Claims: Cover compositions including the compound and excipients.

Limitations and Potential Challenges

• The patent may be challenged based on prior art if similar structures or methods exist.
• Narrow claim language could allow competitors to design around the patent.

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What Is the Patent Landscape Surrounding U.S. Patent 10,512,657?

Existing Patent Environment

The landscape includes patents on similar chemical structures, formulations, or therapeutic uses. These patents belong to competitors, research institutions, or earlier filings from the same applicant.

Key Similar Patents and Patent Families

• Patents on chemical analogs or derivatives with similar therapeutic applications.
• Patents on delivery devices or formulations that enhance bioavailability or stability.

Overlapping and Novel Patents

The following are noted within the landscape:

• Patents claiming the core chemical structure with different substituents.
• Patents claiming specific methods of administration or combination therapies.

Patent Filing Timeline and Jurisdiction

While this patent is U.S.-specific, related applications may exist internationally, particularly in regions with strong biopharmaceutical patent laws like Europe, Japan, and China.

Litigation and Oppositions

No publicly available litigation directly targeting this patent as of the latest data. However, competitive landscape analyses suggest potential challenges if similar patents emerge.

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Conclusion: Significance of Claim Scope and Landscape

U.S. Patent 10,512,657 covers a specific innovation within the drug development pipeline. Its broad claims protect key inventive features, but narrow claim language may invite challenges. The patent landscape features numerous similar patents, which could impact freedom-to-operate and licensing strategies.

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Key Takeaways

• The patent claims focus on a particular formulation or method, with scope defined by claim language.
• Competitors have filed similar patents, creating overlapping areas that could lead to litigation or licensing disputes.
• The patent landscape indicates active innovation, especially around chemical derivatives and delivery systems.
• The patent’s strength depends on the specificity of claims and the existence of prior art.
• Broader claims might be vulnerable to invalidation; narrower claims can limit enforceability.

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FAQs

1. What are the main types of claims in U.S. Patent 10,512,657?
It likely contains composition, method of use, and formulation claims, each defining different aspects of the invention.

2. How does the patent landscape impact the commercial viability of this patent?
Overlapping patents could limit or delay market entry; licensing or litigation may be necessary to secure freedom-to-operate.

3. Can competitors design around this patent?
Yes, if they develop structurally different compounds or alternative methods not covered by the claims.

4. Are there international equivalents of this patent?
Potentially, in jurisdictions that recognize patents on similar chemical structures or therapeutic methods, assessed via Patent Cooperation Treaty filings or national applications.

5. How does the scope of claims influence patent patentability?
Broader claims cover more variations but risk invalidation if prior art exists; narrower claims are easier to defend but provide less coverage.

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References

1. U.S. Patent 10,512,657.
2. [1] Patent Application Publications and Patent Families related to the compound or method.
3. Patent landscape reports on the targeted therapeutic area and chemical class.
4. USPTO patent search portals for related filings and statuses.
5. Legal analyses on patent claim construction and scope.

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Note: For proprietary or detailed patent claim interpretation, consult patent attorneys or formal patent analysis reports.

Drugs Protected by US Patent 10,512,657

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-002	Jul 24, 2024		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-001	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-002	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE

International Family Members for US Patent 10,512,657

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2771003		2023C/521	Belgium
European Patent Office	2771003		301234	Netherlands
European Patent Office	2771003		CA 2023 00017	Denmark
European Patent Office	2771003		122023000029	Germany