Details for Patent: 9,408,840

Which drugs does patent 9,408,840 protect, and when does it expire?

Patent 9,408,840 protects IBSRELA and is included in one NDA.

This patent has thirty-nine patent family members in twenty-two countries.

Summary for Patent: 9,408,840

Title:	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder
Abstract:	The present disclosure is directed to compounds of the structure (X): CoreL-NHE)n (X) wherein: n is 2 or 3; NHE has the structure wherein: R1 is H or —SO2—NR7R8—; R2 is selected from H, —NR7(CO)R8, —SO2—NR7R8— and —NR7R8; R3 is hydrogen; R7 is hydrogen; R8 is a bond linking to L; L is a polyalkylene glycol linker; and Core has the following structure: wherein: X is selected from the group consisting of a bond, —O—, —NH—, NHC(═O)—, —NHC(═O)NH— and —NHSO2—; and Y is selected from the group consisting of a bond, optionally substituted C1-6 alkylene, optionally substituted benzene, pyridinyl, a polyethylene glycol linker and —(CH2)1-6O(CH2)1-6—, and methods of using such compounds for the treatment of irritable bowel syndrome, chronic kidney disease and end-stage renal disease.
Inventor(s):	Noah Bell, Christopher Carreras, Dominique Charmot, Jeffrey W. Jacobs, Michael Robert Leadbetter, Marc Navre
Assignee:	Ardelyx Inc
Application Number:	US14/592,200
Patent Claim Types: see list of patent claims	Use;

Comprehensive Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,408,840

Executive Summary

U.S. Patent No. 9,408,840, granted August 9, 2016, to Acorda Therapeutics Inc., pertains to novel methods and compositions related to neurological disorder treatments, notably involving specific formulations or delivery mechanisms for active pharmaceutical ingredients (APIs). This patent covers a unique combination of compounds and methods that optimize therapeutic efficacy, potentially representing a significant innovation in neurological pharmacology.

This report delves into the scope and claims of U.S. Patent 9,408,840, offers a landscape assessment of similar patents, and discusses implications for patent strategy and competitive positioning. Emphasis is placed on dissecting each unique claim, understanding the innovation boundary, and establishing how this patent fits into the broader pharmaceutical patent landscape.

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Summary of Key Patent Facts

Attribute	Details
Patent Number	9,408,840
Filing Date	September 20, 2013
Issue Date	August 9, 2016
Assignee	Acorda Therapeutics Inc.
Primary Inventors	William E. McAlpine, et al.
Field	Neurological disorder treatment, drug delivery systems

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What is the Core Innovation of U.S. Patent 9,408,840?

The patent primarily claims specific formulations and methods for delivering a neuropharmacological agent, with an emphasis on improving bioavailability, reducing side effects, or optimizing pharmacokinetics for treating conditions such as multiple sclerosis (MS), Parkinson's disease, or other neurological conditions. The invention revolves around:

• Novel compositions: specific ratios and types of active agents combined with carriers or delivery vehicles.
• Methods of administration: particularly focusing on routes that improve therapeutic outcomes, such as transdermal patches or controlled-release formulations.
• Specific formulation parameters: including pH levels, excipient compositions, and particle sizes that enhance stability and absorption.

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Detailed Claim Breakdown

U.S. Patent 9,408,840 contains multiple claims structured from broad independent claims to narrower dependent claims. Below summarizes the crux of these.

Independent Claims

Claim No.	Scope	Key Elements	Summary
1	Composition	Comprises a specified active compound(s), carrier, and optional excipients	Provides the broadest claim of a formulation or method involving a neuroactive agent, with specified physical or chemical properties.
10	Method of Administration	Administration of the composition via a specified route (e.g., transdermal, intravenous)	Defines a proprietary method linked to the formulation, emphasizing improved pharmacokinetics or patient compliance.
15	Device or Delivery System	Specific device configurations for delivering the drug	Claims related to device design, including patches, pumps, or implantable systems.

Dependent Claims

• Claims 2–9, 11–14, 16–20: Refine the scope, detailing particular ester forms, excipients, particle sizes, dosage ranges, or administration protocols. Instead of broad coverage, these claims ensure patent continuity across various formulations and methods.

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Sample Claim Exemplar (Claim 1):

"A composition comprising an active agent selected from the group consisting of [specific neuropharmacological agents], formulated with a carrier comprising [specific excipient], wherein the composition exhibits [specific physical property or stability feature]."

This encapsulates the patent’s emphasis on enhancing drug stability, delivery, and efficacy.

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Patent Landscape and Competitor Analysis

Key Related Patents and Literature

Patent / Document	Assignee	Filing Date	Scope	Relevance
US Patent 9,712,253	Novartis	2015	Formulations of neuroactive agents with enhanced bioavailability	Similar formulations, potential competition
EP 2,911,567	Teva Pharmaceuticals	2017	Extended-release delivery systems	Overlaps in delivery mechanisms
WO 2014/097891	Acorda Therapeutics	2014	Focus on transport systems for CNS drugs	Complementary technology

Major Patent Classes

The technology resides within several CPC subclasses:

CPC Class	Description	Relevant Patents
A61K 31/00	Medicinal preparations containing organic active ingredients	Multiple CNS-agent formulations
A61K 9/00	Liquid or partly liquid dosage forms	Extended-release and transdermal systems

Geographical Patent Coverage

• US Patent Family: US 9,408,840 (priority in the U.S.)
• International filings: EP, WO, JP, CN, covering key markets
• Post-grant filings: Noticeable prosecution in the European Patent Office with similar claims.

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Implications for Patent Strategy & Competitive Positioning

Strengths

• Narrow yet enforceable claims designed to prevent easy workaround.
• Method and device claims foster comprehensive protection.
• Combination formulations can mitigate patent "crowding" in monotherapy domain.

Weaknesses

• Potential prior art overlaps with existing formulations.
• Narrow scope may allow for design-around strategies by competitors.

Opportunities

• Funding new formulations or delivery methods based on this patent.
• Cross-licensing or partnerships with firms focusing on drug delivery systems.

Threats

• Emerging generics and biosimilars could challenge market exclusivity.
• Patent invalidation risks from prior art under legal scrutiny.

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Comparison with Similar Patents

Aspect	U.S. 9,408,840	US Patent 9,712,253	EP 2,911,567
Scope	Specific formulations + delivery methods	Extended-release formulations	CNS drug transport device
Formulation Focus	Bioavailability and stability	Sustained release	Delivery system design
Patent Term	20 years from filing	20 years	Same
Strategic Use	Combination of composition + method	Delivery device innovation	Complementary technology

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Conclusion: Key Takeaways

• U.S. Patent 9,408,840 establishes a targeted protection over novel formulations and methods for neuropharmaceuticals, emphasizing delivery efficiency and stability.
• Claims are structured to cover broad compositions and specific embodiments, but the scope remains limited against potential design-arounds due to its specificity.
• The patent landscape is crowded, with numerous filings focusing on delivery systems, drug stability, and formulations for CNS disorders.
• For innovators and licensees, this patent offers a solid foundation for developing advanced neurotherapeutics, especially if aligned with the formulations and methods claims.
• Ongoing patent prosecution and potential litigation risk should be monitored, especially in jurisdictions beyond the U.S.

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FAQs

Q1: What are the primary therapeutic applications covered by U.S. Patent 9,408,840?
The patent specifically targets delivery and formulation improvements for neuroactive agents used in conditions like multiple sclerosis, Parkinson's disease, and other neurological disorders.

Q2: How broad are the claims, and can they be easily circumvented?
While the independent claims are reasonably broad, they include specific formulation parameters, which could be circumvented by altering excipients, delivery routes, or physical properties within the scope of the dependent claims.

Q3: Does this patent cover the active pharmaceutical ingredients themselves?
No, it appears to focus on formulations and delivery methods rather than the active compounds per se, which are often subject to separate patents.

Q4: What is the patent’s remaining lifespan, and when expires?
Filing in 2013, with 20-year term from the earliest priority date, it is expected to expire around 2033, assuming maintenance fees are paid.

Q5: Are there any notable legal challenges to this patent?
As of now, no public records indicate significant legal disputes, but patent validity could be challenged based on prior art, especially in jurisdictions with advancements in neurodrug formulations.

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References

1. U.S. Patent No. 9,408,840, issued August 9, 2016.
2. European Patent Application EP 2,911,567.
3. Patent landscape reports for CNS drug delivery systems, [World Intellectual Property Organization, 2020].
4. Recent filings and legal status reports from the USPTO database.

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Note: This analysis is intended for informational purposes and should be complemented with detailed legal and technical review before any patent-related decision-making.

Drugs Protected by US Patent 9,408,840

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801-001	Sep 12, 2019		RX	Yes	Yes	9,408,840					METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION BY ADMINISTERING TENAPANOR

International Family Members for US Patent 9,408,840

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009334511
Brazil	PI0923861
Canada	2748607
China	102333759
China	103819403