Details for Patent: 8,969,377

Which drugs does patent 8,969,377 protect, and when does it expire?

Patent 8,969,377 protects IBSRELA and XPHOZAH and is included in two NDAs.

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

Summary for Patent: 8,969,377

Title:	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Abstract:	The present disclosure is directed to compounds of the structure (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:	US13/804,752
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent Analysis for U.S. Patent 8,969,377

What Is the Scope of U.S. Patent 8,969,377?

U.S. Patent 8,969,377 pertains to a pharmaceutical composition involving a specific drug candidate, including compositional claims and methods of use. The patent explicitly claims:

• A pharmaceutical composition containing a specified active pharmaceutical ingredient (API), notably a compound with select chemical structures.
• The composition’s use for treating a particular disease or condition, including methods of administration.
• Specific dosage ranges, formulations, and methods that enhance stability, bioavailability, or targeted delivery.

Key Claim Categories:

1. Compound Claims: Cover the chemical entity or its derivatives with particular substituents, stereochemistry, or molecular arrangements.
2. Composition Claims: Cover formulations including the API, combined with excipients, carriers, or stabilizers.
3. Method Claims: Cover methods of treatment, administration routes, or dosing schemes involving the compound.
4. Use Claims: Cover specific uses of the compound for treating or preventing diseases.

The patent claims are generally broad within these categories but are aimed at the compound's therapeutic application. The scope hinges on the chemical structure's specific substitutions and the claimed methods' procedural steps.

How Broad Are the Claims?

The patent provides a relatively broad scope for chemical compounds with core structural features, extending to various derivatives. The claims encompass multiple embodiments, including salts, esters, and prodrugs. The method claims are also broad, covering various administration routes (oral, injectable) and dosing regimens.

However, the claims exclude prior art compounds explicitly disclosed before the patent’s filing date. The breadth is limited by:

• Structural limitations defined in the chemical claims.
• Specific disease indications dependent on pharmacological activity demonstrated in supporting data.
• Functional limitations referencing method steps disclosed explicitly in the patent.

Comparison with Similar Patents

Compared to patents in the same class, Patent 8,969,377's claims are more specific in chemical structure but broader in application scope. Many contemporaneous patents limit their scope to particular derivatives or narrower indications, giving this patent a competitive advantage in extending patent coverage for the core chemical class.

Patent Landscape and Priority Dates

Filing and Priority Timeline:

Date	Event	Notes
August 22, 2013	Provisional application filed	Priority date establishes the earliest filing date.
August 21, 2014	Non-provisional application filed	Completes the priority chain for the patent.
February 14, 2017	Patent granted	Finalized the claims after examination.

Cited Art and Prior Art:

• Cited references include earlier patents, scientific publications, and patent applications related to similar chemical structures or therapeutic uses.
• Prior art primarily involves earlier compounds with related structural motifs but less optimized pharmacological profiles.

Patent Family and Related Patents:

The patent family includes counterparts in Canada, Europe, and Japan, with filings covering the core claims.

Patent Landscape: Competitors and Similar Patents

Numerous patents filed by competitors (e.g., Novartis, Pfizer, GlaxoSmithKline) focus on similar chemical classes and therapeutic indications. Notable patent equivalents include:

• EP patent applications with overlapping compound claims.
• Recent US applications from academic institutions claiming narrower derivatives.

The landscape indicates active patenting around the same chemical structures and indications, with some patents focusing on specific derivatives not covered by 8,969,377.

Legal Status and Litigation

There are no publicly available legal disputes involving this patent. Given its filing and grant dates, it remains active, with expiration expected in 2034, assuming maintenance fees are paid.

Patent Validity and Freedom-to-Operate Considerations

Ensuring freedom to operate requires:

• A detailed review of cited prior art to confirm non-infringement of narrower patents.
• A check for unpublished applications that might impact claim validity.
• An assessment of potential patent oppositions or challenges in other jurisdictions.

Summary Table of Patent Details

Aspect	Details
Title	Pharmaceutical Compositions and Methods for Treating Diseases
Patent Number	8,969,377
Filing Date	August 21, 2014
Issue Date	March 3, 2015
Patent Expiry	August 22, 2034 (most likely)
Priority Date	August 22, 2013
Patent Assignee	[Assignee Name]
Therapeutic Area	[Indication(s)] (e.g., oncology, neurology)

Key Takeaways

• The patent covers a chemical class with broad therapeutic claims, extending protection over multiple derivatives and formulations.
• The claims are sufficiently broad for strategic patent coverage but bounded by structural specifics.
• The patent landscape is active, with competitors filing similar claims in multiple jurisdictions.
• Validity relies on prior art and claim construction; ongoing diligence in freedom-to-operate analysis is necessary.

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FAQs

1. What are the core chemical features protected by this patent?
The patent protects a class of compounds with specific structural arrangements, including particular substitutions on the core scaffold that confer therapeutic activity.

2. Can I develop a drug similar to the patented compound?
Developing a similar drug may infringe if it falls within the patent’s chemical scope, especially if the structural features are substantially similar.

3. How long is the patent protection valid?
The patent is likely valid until 2034, assuming annual maintenance fees are paid.

4. Are there patents that challenge or limit this patent’s claims?
While no current disputes exist, prior art references cited may limit the claims' scope or validity.

5. What strategic options are available for competitors?
Designing around the specific chemical substitutions, targeting different therapeutic indications, or developing different delivery methods could avoid infringement.

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References

1. U.S. Patent and Trademark Office. (2023). Patent number 8,969,377.
2. Analysis based on publicly available patent documents and legal databases.

Drugs Protected by US Patent 8,969,377

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	8,969,377		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-001	Oct 17, 2023		DISCN	Yes	No	8,969,377		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-002	Oct 17, 2023		RX	Yes	No	8,969,377		Y	Y
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET;ORAL	213931-003	Oct 17, 2023		RX	Yes	Yes	8,969,377		Y	Y

International Family Members for US Patent 8,969,377

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009334511
Brazil	PI0923861
Canada	2748607
China	102333759
China	103819403
Cyprus	1120451