Details for Patent: 10,456,393

Which drugs does patent 10,456,393 protect, and when does it expire?

Patent 10,456,393 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 10,456,393

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 hydrocodone 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:	US16/042,196
Patent Claim Types: see list of patent claims

United States Patent 10,456,393: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 10,456,393, issued on October 29, 2019, is a significant patent in the field of pharmaceuticals, particularly focusing on the treatment of pain in patients with hepatic impairment. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Inventors and Assignees

The patent was invented by Andrew Hartman, Christopher M. Rubino, and Cynthia Y. Robinson, and is assigned to Persion Pharmaceuticals LLC[5].

Background

The patent is part of a series of continuations and related applications, indicating a robust and evolving research and development process. It is a continuation of several earlier applications, including those filed on July 31, 2015, August 22, 2016, and others, highlighting the iterative nature of patent filings in pharmaceutical research[4].

Scope of the Patent

Purpose and Application

The patent pertains to a multiparticulate modified release composition designed for the treatment of pain in human patients, particularly those with hepatic impairment. This is crucial because patients with liver dysfunction often face challenges with standard pain medications due to their metabolization and potential toxicity[4].

Composition Details

The composition includes a combination of active pharmaceutical ingredients, such as opioids, formulated to provide a controlled release profile. This is achieved through a multiparticulate system, which ensures a steady and predictable release of the drug, reducing the risk of overdose and improving patient compliance[4].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically outline the composition, the method of preparation, and the specific characteristics of the multiparticulate system. For example, Claim 1 might describe the composition as a "multiparticulate modified release formulation comprising a plurality of particles, each particle comprising an opioid and a release-controlling polymer"[4].

Dependent Claims

Dependent claims further specify the details of the independent claims, such as the types of opioids used, the specific polymers employed, and the release profiles. These claims help to narrow down the scope and ensure that the invention is clearly defined and distinguishable from prior art[4].

Patent Landscape

Related Patents

The patent is part of a larger family of patents related to pain management and pharmaceutical formulations. Other patents, such as U.S. Patent 10,028,946 and U.S. Patent 10,322,120, also issued to Persion Pharmaceuticals LLC, cover similar aspects of pain treatment and formulation technologies[5].

Expiration Dates

The patent is set to expire on September 12, 2034, which is typical for pharmaceutical patents that often have a 20-year term from the earliest filing date of the application from which the patent was granted[5].

Legal and Regulatory Considerations

Patent Examination Process

The examination process for this patent, like others, involves a thorough review to ensure that the claims are novel, non-obvious, and meet the requirements of patentability. The process can be lengthy and may involve multiple iterations and amendments to the claims to satisfy the patent office's requirements[3].

Litigation and Disputes

Patents in the pharmaceutical sector are often subject to litigation and disputes, particularly regarding the validity and scope of the claims. The case of CYTIVA BIOPROCESS R&D AB v. JSR CORP. illustrates the complexities and challenges involved in patent disputes, where the scope and validity of claims are scrutinized in detail[1].

Impact on Innovation

Patent Scope and Quality

The scope of a patent, as measured by metrics such as independent claim length and count, can influence its impact on innovation. Narrower claims, which are often the result of a rigorous examination process, can provide clearer boundaries and reduce litigation costs, thereby encouraging further innovation[3].

Licensing and Collaboration

Patents like U.S. Patent 10,456,393 can facilitate licensing agreements and collaborations between pharmaceutical companies. These agreements can accelerate the development and commercialization of new treatments, benefiting patients and the healthcare industry as a whole[5].

Key Takeaways

• Specific Application: The patent is designed for treating pain in patients with hepatic impairment using a multiparticulate modified release composition.
• Composition Details: The formulation includes opioids and release-controlling polymers to ensure a controlled release profile.
• Claims Structure: Independent and dependent claims define the scope of the invention, ensuring clarity and distinguishability from prior art.
• Patent Landscape: Part of a larger family of patents related to pain management and pharmaceutical formulations.
• Expiration Date: Set to expire on September 12, 2034.
• Legal Considerations: Subject to rigorous examination and potential litigation to ensure validity and scope.

FAQs

What is the primary purpose of U.S. Patent 10,456,393?

The primary purpose of U.S. Patent 10,456,393 is to provide a multiparticulate modified release composition for the treatment of pain in patients with hepatic impairment.

Who are the inventors of this patent?

The inventors are Andrew Hartman, Christopher M. Rubino, and Cynthia Y. Robinson.

What is the assigned entity for this patent?

The patent is assigned to Persion Pharmaceuticals LLC.

When is the patent set to expire?

The patent is set to expire on September 12, 2034.

How does this patent fit into the broader patent landscape?

It is part of a series of patents related to pain management and pharmaceutical formulations, including other patents like U.S. Patent 10,028,946 and U.S. Patent 10,322,120.

What are the key components of the multiparticulate modified release composition?

The composition includes opioids and release-controlling polymers designed to provide a controlled release profile.

Sources

1. CYTIVA BIOPROCESS R&D AB v. JSR CORP., U.S. Court of Appeals for the Federal Circuit, December 4, 2024.
2. United States Patent - googleapis.com, U.S. Patent No. 10,028,946.
3. Patent Claims and Patent Scope, SSRN, September 29, 2016.
4. United States Patent - googleapis.com, U.S. Patent No. 10,456,393.
5. Generic Zohydro ER Availability, Drugs.com, November 6, 2024.

Drugs Protected by US Patent 10,456,393

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						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						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						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 10,456,393

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
China	103904260
China	105759918