Details for Patent: 10,335,452

Which drugs does patent 10,335,452 protect, and when does it expire?

Patent 10,335,452 protects TERLIVAZ and is included in one NDA.

This patent has thirty-five patent family members in seventeen countries.

Summary for Patent: 10,335,452

Title:	Method of treating patients with hepatorenal syndrome type 1
Abstract:	The principles and embodiments of the present disclosure relate to methods for using terlipressin to treat a patient having impaired renal function associated with liver disease. A patient identified as suffering from HRS-1 is tested to determine if the patient meets at least two out of three criteria, wherein the three criteria include a WBC<4 or >12 cells/μL; HR>90 bpm; and any one of HCO<21 mmol/L or PaCO<32 mmHg or >20 breaths per minute. If the patient meets at least two of the criteria, he or she is administered terlipressin in an amount effective to produce a reduction in serum creatinine of at least 1.0 mg/dL.
Inventor(s):	Jamil Khurram, Pappas Stephen Chris, Potenziano Jim
Assignee:	Mallinckrodt Hospital Products IP Limited
Application Number:	US14920392
Patent Claim Types: see list of patent claims

United States Patent 10,335,452: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,335,452, titled "Method of treating patients with hepatorenal syndrome type 1," is a significant patent in the medical field, particularly in the treatment of hepatorenal syndrome. This patent, issued to Mallinckrodt Hospital Products IP Limited, covers a specific method of treatment using terlipressin, a synthetic analogue of vasopressin.

Patent Overview

Issuance and Inventors

The patent was issued on July 2, 2019, to inventors Jamil Khurram, Stephen Chris Pappas, and Jim Potenziano[1][4].

Patent Application and Priority

The patent application claims priority under 35 USC § 119(e) to U.S. Patent Application Ser. No. 62/151,384, filed on April 22, 2015[4].

Scope of the Patent

Method of Treatment

The patent describes a method for treating patients with hepatorenal syndrome type 1 (HRS-1), a condition characterized by rapid deterioration of kidney function in patients with advanced liver disease. The method involves the administration of terlipressin, which helps in improving kidney function by reducing vasoconstriction and improving renal perfusion[1][4].

Key Components

• Terlipressin Administration: The patent specifies the use of terlipressin acetate, administered intravenously, to treat HRS-1. This is the active ingredient in the brand name drug Terlivaz.
• Dosage and Administration: The patent details the dosage regimen and the criteria for patient selection, ensuring that the treatment is tailored to the specific needs of patients with HRS-1[4].

Claims of the Patent

Independent and Dependent Claims

The patent includes both independent and dependent claims that define the scope of the invention. Independent claims outline the core aspects of the method, while dependent claims provide additional details and variations of the method.

• Independent Claims: These claims define the essential steps and components of the treatment method, including the administration of terlipressin and the criteria for patient selection.
• Dependent Claims: These claims elaborate on the independent claims by specifying additional aspects such as dosage regimens, treatment duration, and monitoring criteria[4].

Claim Language and Scope

The claim language is critical in defining the patent's scope. The patent uses specific language to describe the method, ensuring that it is clear and distinct from other treatments. Metrics such as independent claim length and count can be used to measure the scope and clarity of the patent claims[3].

Patent Landscape

Exclusivity and Patent Protection

The patent is protected by both patent and exclusivity rights granted by the FDA.

• Patent Protection: The patent assigns exclusive legal rights to the patent holder, Mallinckrodt Hospital Products IP Limited, until its expiration. Typically, a patent expires 20 years from the date of filing, but this can vary based on several factors[1][3].
• Exclusivity Rights: The FDA has granted exclusivity rights to the manufacturer, which include a new chemical entity (NCE) exclusivity until September 14, 2027, and an exclusivity for improving kidney function in adults with HRS-1 until September 14, 2029[1].

Related Patents and Exclusivities

The patent landscape for terlipressin and its use in treating HRS-1 is relatively clear, with this patent being a key player.

• No Generic Version: As of the last update, there is no therapeutically equivalent generic version of Terlivaz available in the United States, ensuring that the patent holder maintains market exclusivity for the specified period[1].

Impact on the Medical Field

Treatment of Hepatorenal Syndrome

The method described in the patent provides a significant advancement in the treatment of HRS-1. Terlipressin has been shown to improve kidney function and reduce mortality in patients with this condition.

• Clinical Significance: The treatment method outlined in the patent has been clinically validated, offering a viable option for patients who previously had limited therapeutic choices[4].

Economic and Market Impact

The exclusivity rights and patent protection ensure that Mallinckrodt Hospital Products IP Limited has a monopoly on the market for this specific treatment method.

• Market Dominance: The absence of a generic version and the exclusivity rights granted by the FDA give the patent holder significant market dominance, allowing them to set prices and control distribution without immediate competition[1].

Potential Challenges and Controversies

Patent Scope and Clarity

The scope and clarity of patent claims can be contentious issues. Overly broad or unclear claims can lead to litigation and disputes over patent validity.

• Litigation Risks: The patent's scope and claim language must be carefully crafted to avoid potential litigation risks. Metrics such as independent claim length and count can help in assessing the clarity and breadth of the patent claims[3].

Generic and Counterfeit Concerns

The lack of a generic version can lead to concerns about counterfeit medications.

• Counterfeit Medications: The FDA warns against purchasing medications from fraudulent online pharmacies, which may sell counterfeit versions of Terlivaz. This underscores the importance of buying medications from reputable sources[1].

Conclusion

United States Patent 10,335,452 is a critical patent in the medical field, particularly for the treatment of hepatorenal syndrome type 1. The patent's scope, claims, and exclusivity rights provide a comprehensive framework for the use of terlipressin in this context. Understanding the patent landscape and the potential challenges associated with it is essential for both medical professionals and industry stakeholders.

Key Takeaways

• Method of Treatment: The patent describes a method for treating HRS-1 using terlipressin.
• Exclusivity Rights: The FDA has granted exclusivity rights until 2027 and 2029.
• Patent Protection: The patent is protected until its expiration, typically 20 years from the filing date.
• No Generic Version: There is currently no generic version of Terlivaz available in the U.S.
• Clinical Significance: The treatment method has been clinically validated and offers a significant therapeutic option.

FAQs

1. What is the main subject of United States Patent 10,335,452?

   • The main subject is a method for treating patients with hepatorenal syndrome type 1 using terlipressin.

2. Who are the inventors of this patent?

   • The inventors are Jamil Khurram, Stephen Chris Pappas, and Jim Potenziano.

3. What is the current status of generic versions of Terlivaz?

   • There is currently no therapeutically equivalent generic version of Terlivaz available in the United States.

4. What are the exclusivity rights granted to the patent holder?

   • The FDA has granted exclusivity rights until September 14, 2027, for new chemical entity exclusivity and until September 14, 2029, for improving kidney function in adults with HRS-1.

5. Why is it important to buy medications from reputable sources?

   • Buying medications from reputable sources is crucial to avoid counterfeit medications, which can be unsafe and ineffective.

Sources

1. Drugs.com - Generic Terlivaz Availability
2. Pharmacompass - US Patent 10335452
3. Hoover Institution - Patent Claims and Patent Scope
4. Google Patents - US10335452B2 - Method of treating patients with hepatorenal syndrome type 1

Drugs Protected by US Patent 10,335,452

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes						A METHOD TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION

International Family Members for US Patent 10,335,452

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015335855
Australia	2022288996
Brazil	112023023894
Canada	2965325
Canada	3219851