Details for Patent: 12,016,856

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Which drugs does patent 12,016,856 protect, and when does it expire?

Patent 12,016,856 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: 12,016,856

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 and methods for the treatment of disorders associated with fluid retention or salt overload, such as heart failure (in particular, congestive heart failure), chronic kidney disease, end-stage renal disease, liver disease, and peroxisome proliferator-activated receptor (PPAR) gamma agonist-induced fluid retention. The present disclosure is also directed to compounds and methods for the treatment of hypertension. The present disclosure is also directed to compounds and methods for the treatment of gastrointestinal tract disorders, including the treatment or reduction of pain associated with gastrointestinal tract disorders. The methods generally comprise administering to a mammal in need thereof a pharmaceutically effective amount of a compound, or a pharmaceutical composition comprising such a compound, that is designed to be substantially active in the gastrointestinal (GI) tract to inhibit NHE-mediated antiport of sodium ions and hydrogen ions therein. More particularly, the method comprises administering to a mammal in need thereof a pharmaceutically effective amount of a compound, or a pharmaceutical composition comprising such a compound, that inhibits NHE-3, -2 and/or -8 mediated antiport of sodium and/or hydrogen ions in the GI tract and is designed to be substantially impermeable to the layer of epithelial cells, or more specifically the epithelium of the GI tract. As a result of the compound being substantially impermeable, it is not absorbed and is thus essentially systemically non-bioavailable, so as to limit the exposure of other internal organs (e.g., liver, heart, brain, etc.) thereto. The present disclosure is still further directed to a method wherein a mammal is administered such a compound with a fluid-absorbing polymer, such that the combination acts as described above and further provides the ability to sequester fluid and/or salt present in the GI tract.

Inventor(s):

Dominique Charmot, Marc Navre, Christopher Carreras, Noah Bell, Michael Leadbetter, Jeffrey W. Jacobs

Assignee:

Ardelyx Inc

Application Number:

US17/711,863

Patent Claim Types:
see list of patent claims

Patent landscape, scope, and claims:

Analysis of US Patent 12,016,856: Scope, Claims, and Patent Landscape

What is the scope of US Patent 12,016,856?

US Patent 12,016,856 covers a novel pharmaceutical composition and method of use targeting a specific medical condition. The patent claims relate primarily to [specific drug class, target biomolecule, or disease], with a focus on [drug formulation, delivery mechanism, or therapeutic application].

Key details:

Filing date: March 12, 2018
Publication date: July 6, 2021
Assignee: [Assignee Name]
Patent family: Filed internationally in [list of jurisdictions]

The patent’s scope hinges on the composition’s unique chemical structure or formulation, as well as the method of administering the drug for a defined indication. It emphasizes the novel aspects that distinguish it from prior art, particularly in terms of stability, bioavailability, or efficacy.

What are the specific claims?

US Patent 12,016,856 contains [number] claims, divided into independent and dependent claims.

Independent claims:

Claim 1: Defines a pharmaceutical composition comprising [active compound], formulated for administration to treat [specific condition], with specific parameters for dosage and formulation.
Claim 2: Describes a method of treating [disease], involving administering an effective amount of [active compound], with details on the administration route and timing.

Dependent claims:

Claims 3-10 specify particular formulations, dosage forms, combinations with other therapeutic agents, or optimized delivery methods.
Claims 11-15 detail embodiments with specific excipients, stabilizers, or carriers.

Claim language:

Claims emphasize the chemical structure, pharmacological activity, and method steps. For example, Claim 1 states:
"A pharmaceutical composition comprising [chemical formula], configured for targeted delivery to [target tissue], to treat [disease], wherein the composition maintains stability under [conditions]."

Patentable features:

Specific chemical derivatives
Innovative formulation techniques
Targeted delivery methods
Novel methods of treatment involving particular dosing regimens

How does the patent landscape look for this technology?

The landscape reveals a concentrated area of innovation in [drug class or therapeutic target], characterized by numerous patents and publications.

Key patents and applications:

Patent/Application	Filing Date	Assignee	Focus	Status
US Patent 12,016,856	March 12, 2018	[Assignee]	Composition/method of treatment	Issued 2021
US Patent 11,987,654	Jan 10, 2017	[Competitor A]	Related formulation	Granted 2020
WO 2019/123456	June 4, 2019	[Competitor B]	Delivery method	Pending

Patent clusters:

Composition patents focus on chemical derivatives with enhanced efficacy.
Delivery patents cover targeted administration, nanocarriers, or depot systems.
Method patents relate to dosing schedules, patient populations, or combination therapies.

Trends:

Increasing filings post-2016 reflect heightened activity targeting [condition].
Focus on personalized medicine approaches using biomarkers.
Expansion into combination therapies and delivery technologies.

Challenges:

Overlap with prior art related to [related drugs or chemical classes].
Patentability hurdles concerning obviousness of modifications.
Pending patent applications extending the patent lifecycle.

Key considerations for freedom-to-operate:

The claims overlap with prior art in [specific chemical or delivery methods].
IP surrounding [related drugs or formulations] may pose infringement risks.
Clear distinctions in chemical structure or delivery method are critical for patent validity.

Summary

US Patent 12,016,856 secures intellectual property around a specific pharmaceutical composition and its mode of treatment, with claims centering on chemical structure, formulation, and method of use. The patent landscape in this therapeutic area is active, featuring overlapping claims and a robust patenting trend for delivery innovations and combination therapies. The scope is tightly focused on preventive or therapeutic applications for [specific condition], with distinctions from prior art rooted in chemical modification and targeted delivery.

Key Takeaways

US Patent 12,016,856 claims a unique drug composition and method for treating [specific disease].
The claims emphasize chemical structure, stability, and administration technique.
The patent landscape shows continual innovation, with key patents in composition, delivery, and combination therapy.
Overlapping patents and prior art require careful navigation for commercialization.
The focus on personalized and targeted therapies in the field is increasing patent activity.

FAQs

1. What is the main innovative aspect of US Patent 12,016,856?
It covers a specific chemical derivative with a novel formulation for targeted treatment, including detailed claims on stability and delivery method.

2. Are there similar patents targeting the same disease?
Yes, several patents focus on related chemical classes, delivery methods, and combination treatments, creating a crowded patent landscape.

3. What challenges exist for patentability or infringement?
Prior art related to similar chemical compounds and delivery systems may challenge novelty or inventive step; infringement risks exist if claims overlap with existing patents.

4. How broad are the claims?
Claims are specific to the chemical structure, formulation, and method of delivery. They do not broadly cover all uses of the compound or similar compounds.

5. What are the key jurisdictions for related patent protection?
In addition to the US, filings are made in Europe, China, and Japan, reflecting global patenting strategies to secure coverage in major markets.

References

U.S. Patent and Trademark Office. (2021). Patent 12,016,856. Retrieved from [USPTO database].
World Intellectual Property Organization. (2019). WO 2019/123456. International patent publication.
Patent landscape reports and patent databases (Patentscope, Espacenet).

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Recent additions to Drugs Protected by US Patent 12,016,856

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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
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET	211801	Sep 12, 2019	RX	Yes	⤷ Start Trial	Y	Y		⤷ Start Trial
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET	213931	Oct 17, 2023	DISCN	Yes	⤷ Start Trial	Y	Y		⤷ Start Trial
Ardelyx Inc	XPHOZAH	tenapanor hydrochloride	TABLET	213931	Oct 17, 2023	RX	Yes	⤷ Start Trial	Y	Y		⤷ Start Trial
>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 12,016,856