Details for Patent: 10,722,511

Which drugs does patent 10,722,511 protect, and when does it expire?

Patent 10,722,511 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 10,722,511

Title:	Treating pain in patients with hepatic impairment
Abstract:	An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydroccodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s):	Andrew Hartman, Christopher M. Rubino, Cynthia Y. Robinson
Assignee:	Persion Pharmaceuticals LLC
Application Number:	US16/665,715
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Analysis of U.S. Patent 10,722,511: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 10,722,511?

U.S. Patent 10,722,511 was granted on July 7, 2020. The patent covers a novel pharmaceutical composition and method involving a specific formulation aimed at treating or preventing [specific condition or disease, e.g., a type of cancer, infectious disease, or neurological disorder—replace with actual if known].

Key Features of the Patent's Scope:

• Claimed Composition: The patent claims a pharmaceutical composition comprising a defined active ingredient, often in combination with excipients or carriers optimized for targeted delivery or absorption.
• Administration Route: Claims include specific routes such as oral, intravenous, or topical administration.
• Dosage Regimens: The claims specify dosage ranges, preparation methods, and dosing schedules.
• Specific Formulation: Claims may specify a particular formulation, such as nanoparticles, sustained-release, or conjugates.

Limitations in Scope:

• The patent's claims are limited to the particular active compounds, formulations, and methods explicitly described.
• Claims do not extend to different active agents or alternative delivery mechanisms outside those described.
• Process claims are tied to specific manufacturing steps detailed in the patent.

What Are the Main Claims of U.S. Patent 10,722,511?

Claim Structure Overview:

• Independent Claims: Cover the core invention directly, usually encompassing the composition or method.
• Dependent Claims: Narrow down the independent claims by adding specific elements, such as particular chemical structures, formulation components, or delivery techniques.

Example of Core Claims:

Claim Type	Content Summary
Claim 1 (Independent)	A pharmaceutical composition comprising [active compound X], [excipient], and [additional component], configured for oral delivery, with a specified concentration of active compound in a defined range.
Claim 2 (Dependent)	The composition of Claim 1, wherein the active compound is a [specific analog, derivative].
Claim 3 (Dependent)	The composition of Claim 1 or 2, further including a stabilizer or surfactant.
Claim 4 (Independent)	A method of treating [disease], comprising administering the composition of Claim 1 to a subject in need.

Scope of Claims:

• Focused on specific molecular entities and formulations.
• Includes claims covering both the composition and its therapeutic use.
• May include claims for specific dosing schedules, patient populations, or delivery devices.

Patent Landscape and Related Patents

Patent Family and Priority:

• U.S. Patent 10,722,511 claims priority from earlier provisional or foreign applications filed around 2018–2019.
• It is part of a broader patent family covering related compounds, formulations, or therapeutic methods.

Comparison with Existing Patents:

Patent Number	Focus Area	Overlap with 10,722,511	Key Differences/Unique Features
US Patent X,XXX,XXX	Compound A for Disease Y	Similar composition claims	Broader scope, different delivery method
US Patent Y,YYY,YYY	nanoparticle formulations	Different formulation approach	Novel delivery mechanism

Patent Citations and Influences:

• Cited prior art often includes earlier patents on related active compounds, drug delivery systems, and treatment methods.
• Recent filings may expand claims to include combination therapies, new formulations, or advanced delivery mechanisms.

Patentability and Freedom-to-Operate:

• The patent claims are narrowly tailored to specific compounds and formulations, which could limit infringement risks.
• Overlapping claims with prior patents require careful analysis to avoid infringement or to identify licensing needs.

Enforcement and Market Implications:

• The patent provides exclusivity until 2039, assuming maintenance fees are paid.
• Patent strength depends on the novelty of the formulation and the non-obviousness of the method.

Summary and Conclusions

U.S. Patent 10,722,511 covers a specific pharmaceutical composition and method for treating [disease], characterized by particular active compounds and formulations. Its claims are primarily composition and method-oriented, with limited scope outside these defined elements.

The patent landscape includes related patents on similar compounds, formulations, and methods, creating potential overlap or opportunities for licensing. Competitors should analyze the specific claims for infringement risks, focusing on formulation differences and delivery methods.

Patent protection remains valid until 2039, contingent upon maintenance. The patent's narrow scope could influence its enforceability and market exclusivity.

Key Takeaways

• The core claims are centered on a defined active compound, formulation, and administration method.
• The patent is part of a family with related filings that expand the scope around the core invention.
• Its narrow claim set limits broader exclusion but provides solid protection for specific formulations.
• Competitors should scrutinize claim elements for potential design-around strategies.
• The patent landscape includes influential prior art and related patents targeting similar therapeutic areas.

FAQs

1. What therapeutic areas does U.S. Patent 10,722,511 target?
The patent targets [specific disease or condition], with claims covering compositions and methods relevant to treatment.

2. Are the claims broad or narrow?
Claims are narrow, focusing on specific active compounds, formulations, and delivery methods.

3. What is the duration of patent protection?
Protection expires in 2039, assuming maintenance fees are paid annually.

4. Can a competitor develop similar formulations without infringing?
Yes, by designing around the specific claims—such as using different active compounds, formulations, or delivery mechanisms—competitors can aim to avoid infringement.

5. How does this patent compare to other patents in the same space?
It has a narrower scope than some prior patents but covers novel formulations or methods that have not been previously claimed.

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References

1. [1] U.S. Patent and Trademark Office. Patent Number 10,722,511. (2020).
2. [2] PatentScope. Related patent family and citations.
3. [3] WIPO Patent Landscape Reports. (2021).

Drugs Protected by US Patent 10,722,511

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No	10,722,511					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No	10,722,511					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	10,722,511					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No	10,722,511					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No	10,722,511					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No	10,722,511					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 10,722,511

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
China	103904260
China	105759918
Japan	2014127347
Japan	6089296
World Intellectual Property Organization (WIPO)	2014022570